MTPA and Aquestive Sign a License and Supply Agreement for Exservan (riluzole) to Treat ALS in the US

Shots:

  • Aquestive will receive upfront, milestones, royalties on net sales for Exservan (oral film formulation) in the US and will earn revenue pursuant to the exclusive supply agreement
  • MTPA to commercialize Exservan in the US while Aquestive will serve as the exclusive sole manufacturer and supplier for the product
  • Exservan is an oral film formulation of riluzole, expected to be available in the mid of 2021

Click here ­to­ read full press release/ article | Ref: MTPA | Image: PR Newswire

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Servier and MiNA Therapeutics Collaborate to Develop saRNA Therapies for Neurological Diseases

Shots:

  • MiNA to receive $267.6M in up front, exclusivity fee on first neurological target and will be eligible to receive research, development, regulatory and commercial milestones along with royalties
  • Servier will lead pre/ clinical development of lead candidates and will have the rights to commercialize any products that emerges from the collaboration
  • The collaboration integrates Servier’s CNS expertise and MiNA’s small activating RNA technology to identify new potential treatments for restoring normal cell function in neurological disorders

Click here ­to­ read full press release/ article | Ref: Businesswire| Image: Nohat

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Bio Integrates 2021 (Digital)

Making new connections is vital to helping the biotech industry continue their journey. Bio Integrates creates these opportunities and provides attendees with significant opportunities to learn from and interact with our growing community, to enhance both current and future needs.

Our debate-led format provides our attendees with the opportunity to hear from and ask questions of those that have succeeded in their respective fields, whilst our face-to-face networking platform enables a replication of the chance encounters you experience at live events. Add to this opening address and fireside chats with key industry figureheads, and new for this year our ‘C-Suite Series’ from thought leaders, you can see why Bio Integrates is an event unlike others.

WHO ATTENDS BIO INTEGRATES?

From a standing start in 2019, Bio Integrates is now in its third year and attracts over 400 senior executive attendees from:

  • Biotech Organisations
  • Pharma Organisations
  • CDMOs & CROs
  • Investors
  • Regulators
  • Supply chain solution providers
  • Patient Groups

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Prescient Healthcare Group to Partner with Bridgepoint Development Capital

The partnership will further enhance the depth, breadth and value of services for Prescient’s pharmaceutical and biotech clients.

LONDON, January 21, 2021: Prescient Healthcare Group (Prescient), a global product strategy advisory firm serving the pharmaceutical and biotech industries, announced today that Bridgepoint Development Capital, part of Bridgepoint, the international alternative asset management group, has agreed to invest in the business for an undisclosed sum, replacing current investor Baird Capital as the majority shareholder.

Founded in 2007, Prescient is headquartered in London and has offices in the US, India and China. The business provides product strategy services to help its clients make better clinical and commercial decisions, resulting in enhanced outcomes for patients. Prescient works with many of the leading multinational pharmaceutical companies, as well as a growing number of emerging biotech and specialty pharmaceutical organizations. Prescient has formed a partnership with Bridgepoint to support the continued scaling of its talent platform, client value proposition and global infrastructure.

“We are thrilled to be partnering with Bridgepoint, which has an impressive track record supporting the scaling of people-based businesses. Bridgepoint buys into our mission of becoming the biopharma strategy partner most respected for its people, expertise and impact,” said Jamie Denison-Pender, Prescient CEO. “I’m excited by the collaborative approach and hunger for excellence that Bridgepoint will bring to the boardroom and much look forward to our partnership as we continue to invest in our passion for helping our amazing clients develop and commercialize innovative treatments that bring such hope and relief to patients globally.”

“We’re delighted to partner with Prescient to help it drive growth and consolidate its market leadership and share management’s ambitions for the expansion of the Prescient platform. This will be achieved through a combination of investment to enhance scale and expertise, organic growth and selective M&A, with the aim of becoming the leading technology- and data-enabled strategic product partner of choice for decision support and advisory services to the large pharma industry,” said Stephen Bonnard, partner at Bridgepoint Development Capital.

Dr. Nick Edwards will remain Prescient’s Chairman. Baird Capital will be reinvesting in the company as a minority shareholder alongside Bridgepoint.

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Lilly and Merus Collaborate to Discover Novel T-Cell Re-Directing Bispecific Antibodies

Shots:

  • Merus to receive $40M up front, $20M as an equity investment, ~$540M as development & commercial milestones making it a total of $1.6B for three products, along with royalties, following the commercialization of therapies
  • Merus will lead discovery and early-stage research activities while Loxo Oncology at Lilly will be responsible for additional research, development, and commercialization activities
  • The collaboration leverages Merus’ Biclonics platform along with the scientific & rational drug design expertise of Loxo Oncology at Lilly to research and develop up to three CD3-engaging T-cell redirecting bispecific Ab therapies

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: Bilaterals.org

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Janssen Signs a Research Agreement with TenNor to Develop Treatments for Nontuberculous Mycobacteria Diseases

Shots:

  • The companies plan to leverage TenNor’s multitargeting drug conjugation platform to discover new therapies for NTM diseases. The agreement was facilitated by J&J
  • The focus of the pact to discover and develop novel therapies for NTM diseases with the potential to shorten the duration of treatment with better safety and efficacy
  • The collaboration builds on the scientific know-how and background IP of TenNor associated with its drug conjugation technology. The collaboration will integrate companies’ expertise together to discover new treatment modalities for NTM diseases

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: Web24 News

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Boehringer Ingelheim Collaborates with Cure Genetics to Develop Next-Generation Liver-Targeted Gene Therapy

Shots:

  • The companies collaborated to develop AAV vectors deploying Cure Genetics’ VELP platform to develop next-generation gene therapies
  • The focus of the pact is to provide new AAV serotypes for patients. The collaboration integrates Boehringer Ingelheim’s experience in disease biology and gene therapy development with Cure Genetics’ AAV expertise in library construction and in vivo AAV screening
  • The VELP technology provides effective solutions in increasing the efficiency of novel AAV screening, further expanding the efforts in the area of gene therapy development

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: GMP News

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Cerner Leadership Changes, Other Key Executives Hires

Cerner announced some leadership changes promoting long-time associates Travis Dalton to Chief Client & Services Officer and Dan Devers to Chief Legal Counsel. After long, respected, meaningful careers at Cerner, John Peterzalek and Randy Sims will be departing.


Cognoa, the leading pediatric behavioral health company developing diagnostic and therapeutic solutions for children living with autism and other behavioral health conditions appoints Eric B. Mosbrooker as Chief Operations Officer. Mosbrooker will be responsible for overseeing and leading the global commercialization of the company’s product offerings, expanding Cognoa’s operational capabilities and implementing scalable business processes.


Discovery Health Partners announced that Sameer K. Mishra has joined the company as Chief Information Officer. Leveraging his significant health payer technology experience, Mishra will lead Discovery’s dedicated IT staff and evolve the company’s technology platform.


Medical Microinstruments (MMI) SpA, hires Mark Toland as Chief Executive Officer. He brings more than 25 years of experience in the medical device industry and most recently served as President and CEO of Corindus, a vascular robotics company that Siemens Healthineers acquired for $1.1 billion in 2019. Following the CE mark of MMI’s Symani Surgical System® in 2019 and successfully completing the first human use cases in 2020, Toland will drive the company’s strategic direction from the developmental stage to broad commercialization.


Dr. Marilyn Ritholz and Dr. David Horwitz will join Chairman Eric Milledge on Dario Health’s scientific advisory board. Dr. Ritholz is a psychologist at Joslin Diabetes Center, a Harvard Medical School affiliate, and Dr. Horwitz is the former Global Chief Medical Officer of Johnson and Johnson Diabetes Institute. They will work on advancing Dario’s technical leadership and help to guide the development of its technology roadmap.


DrChrono expands its senior leadership team with two new hires joining the company. Shahram Famorzadeh will be joining as Senior Vice President of Engineering, responsible for scaling DrChrono’s platform to the next level to support its growing network of physicians and practices, and Jason Rasmussen has joined as Senior Vice President of Revenue, contributing his expertise to DrChrono’s financial operations team.


Vave Health announced two additions to its executive team and advisory board to support the company’s accelerated growth in the medical imaging market. David Garner, a long-time veteran of point-of-care ultrasound and previous vice president at Butterfly Network, brings more than 22 years of experience to Vave Health, and Terri Bresenham, founder of TruNorth Health Advisors and recognized global healthcare expert, joins as a member of the company’s advisory board.


Anang Chokshi, PT, DPT, OCS, SCS joins Include Health as Chief Clinical Officer (CCO). Chokshi joins IncludeHealth’s executive team to provide clinical and technical expertise as IncludeHealth expands its portfolio of products. 


Conversion Labs, Inc. appoints licensed personal care and wellness physician and psychiatrist, Dr. Anthony Puopolo, to the new position of chief medical officer. Dr. Puopolo will be responsible for overseeing the company’s rapidly expanding network of state-licensed physicians and ensuring that the company is delivering the highest quality of care.


BioCardia®, Inc. appoints Krisztina Zsebo, Ph.D., a 31-year veteran of the biotech industry, to its Board of Directors following her election at BioCardia’s 2020 Annual Meeting of Stockholders in December 2020.


Achiko AG appoints biotechnology research scientist and entrepreneur Dr. Morris S. Berrie to the position of President, and business leader in the life science industry Richard Lingard to the position of SVP Commercialization.

ApprioHealth announces the addition of Carl Swart as chief operating officer (COO). Prior to joining ApprioHealth, Swart served as the vice president for revenue cycle for Ensemble Health Partners. Additionally, he spent nearly a decade with Mercy Health as a market vice president.

Takeda and KSQ Collaborate to Develop and Commercialize Novel Immuno-Oncology Therapies

Shots:

  • KSQ to receive $100M+ as up front and preclinical milestones and up to $400M+/ program in option payment and development & commercialization milestones along with royalties on sales of each approved products
  • The deal includes two KSQ’s previously identified & validated T-cell targets with the potential to introduce two additional targets to the collaboration
  • Takeda will lead to funding for all development & commercialization activities. KSQ to get an option to participate in cost/profit sharing on one of the two products based on the T-cell targets previously identified and validated by KSQ, in the US and retain royalties on all ex-US sales for that product

Click here ­to­ read full press release/ article | Ref: Businesswire | Image: KSQ Therapeutics

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Sanofi Signs a License Agreement with Biond for BND-22

Shots:

  • Biond to receive $125M up front in cash and will be eligible to receive ~$1B+ as development, regulatory & commercial milestones, along with royalties on sales of the therapy
  • Biond will lead P-Ia study of BND-22, assessing its safety & tolerability as a single agent and in combination with approved cancer therapies as well as exploring potential associations b/w BND-22 anti-tumor activity, select tumor and blood-based biomarkers. Sanofi will be further responsible for clinical development and commercialization of BND-22
  • BND-22 is a humanized IgG4, antagonist Ab targeting ILT2 receptor in development for solid tumors. The first P-Ia study of BND-22 is anticipated to start by mid-2021

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: 20 Minutes

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AstraZeneca Collaborates with Adaptive on Mapping Immune Response in Cancer

Shots:

  • The companies collaborated to evaluate the use of immunoSEQ T-MAP, for which Adaptive will receive quarterly payments + sequencing and data mapping fees
  • AstraZeneca to provide cancer patients’ biological samples while Adaptive will sequence the samples & deliver TCR-antigen mapping data using its clinical immunomics database of 58B+ immune cell receptors and antigens
  • AstraZeneca gets an option to enter into an agreement with Adaptive for the development & commercialization of a CDx or therapeutic application based on T-MAP data. ImmunoSEQ T-MAP combines the sequencing and mapping capabilities of Adaptive to map TCRs to antigens, across AZ’s oncology portfolio

Click here ­to­ read full press release/ article | Ref: Adaptive | Image: Glassdoor

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Novartis In-Licenses BieGene’s Tislelizumab to Expand its Oncology Portfolio

Shots:

  • BieGene to receive $650M as up front along with milestones and royalties and will retain rights to Tislelizumab in China and other countries
  • Novartis to get the development & commercialization rights to tislelizumab in the US, Canada, Mexico, EU, UK, Norway, Switzerland, Iceland, Liechtenstein, Russia, & Japan. Additionally, the companies have identified multiple tislelizumab + Novartis’ therapy combination clinical trial opportunities in solid tumors
  • Tislelizumab is an anti-PD-1 mAb, designed to minimize binding to FcγR on macrophages and is approved in China for patients with cHL and m-UC in China while 15 registration-enabling clinical trials under way in NSCLC and other solid tumors

Click here ­to­ read full press release/ article | Ref: Novartis | Image: Outsourcing Pharma

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Almirall and Tyris Collaborate to Develop Next Generation Gene Therapies

Shots:

  • Tyris to receive up front, research milestone along with research funding and will be responsible for generating clinical lead candidates and will further progress them to clinical development
  • Almirall to get an exclusive option to acquire gene therapies and progress them through clinical development to commercialization
  • The collaboration will integrate Tyris’s non-viral based gene therapy technology and Almirall’s expertise in medical dermatology. The alliance will focus on developing next-generation gene therapies with transformational potential for rare genetic dermatology diseases

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: Nature

The post Almirall and Tyris Collaborate to Develop Next Generation Gene Therapies first appeared on PharmaShots.

Bayer Collaborates with CureVac for CVnCoV Against COVID-19

Shots:

  • Bayer to support the development, supply and key territory operations of CureVac´s COVID-19 vaccine candidate, CVnCoV and will contribute its expertise and established infrastructure in numerous area
  • Curevac will be the MAH for the product while Bayer will support CureVac with country operations within the EU and additional markets. Additionally, Bayer has an option to MAH outside the EU
  • The companies plan to combine their strengths for CureVac to be in a position to supply hundreds of millions of CVnCoV doses across the globe

Click here ­to­ read full press release/ article | Ref: Bayer | Image: GMPNews

The post Bayer Collaborates with CureVac for CVnCoV Against COVID-19 first appeared on PharmaShots.

Pfizer Signs a License and Supply Agreement with ImaginAb for CD8 ImmunoPET Technology

Shots:

  • ImaginAb to receive license fees and payments for manufacturing and other support and will supply clinical doses of 89Zr CD8 Immuno-PET agent to Pfizer for use in select oncology clinical trials
  • ImaginAb will provide technical, clinical & regulatory support to Pfizer
  • The collaboration follows the pre-competitive alliance b/w ImaginAb, Pfizer and other global companies focusing on the development of 89Zr CD8 ImmunoPET technology, signed in Oct 14, 2019

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: PRNewswire

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Genentech Signs ~$1B Pact with Ribometrix to Develop RNA-Targeted Small Molecule Therapies

Shots:

  • Ribometrix to receive $25M up front, ~$1B+ as milestones along with royalties on sales of therapies emerges from the collaboration
  • The companies collaborated on the discovery & preclinical development of programs. Genentech will lead further development and commercialization and will have exclusive rights to several predefined targets including an exclusive global license for the development and commercialization of molecules
  • Ribometrix will leverage its discovery platform to identify & optimize small molecule compounds modulating RNA function by targeting 3D RNA structures

Click here ­to­ read full press release/ article | Ref: Businesswire | Image: New Indian Express

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AbbVie Reports Results of Skyrizi (Risankizumab) in P-III Studies for Active Psoriatic Arthritis

Shots:

  • The two P-III studies KEEPsAKE-1 & -2 involves assessing Skyrizi (150mg) vs PBO followed by risankizumab (150mg, @24wks.) in patients with active PsA who had an inadequate response or intolerant to at least one biologic therapy and/or non-biologic DMARDs respectively
  • Results: ACR20 (57% & 51% vs 34% & 27%); ACR50 (33% & 26% vs 11% & 9%); ACR70 (15% & 12% vs 5% & 6%); PASI 90 (52% & 55% vs 10% & 10%); HAQ-DI (-0.31 & -0.22 vs -0.11 & -0.05); MDA (25% & 26% vs 10% & 11%) respectively
  • The safety profile is consistent with the known profile of risankizumab in psoriasis patients. Skyrizi is an IL-23 inhibitor, being developed in collaboration with Boehringer Ingelheim

Click here ­to­ read full press release/ article | Ref: Abbvie | Image: Modern Healthcare

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Biogen Signs a License Agreement with ViGeneron for Ophthalmic Gene Therapy Development

Shots:

  • ViGeneron to receive an up front and R&D funding for the mutually agreed workplan and will receive development, regulatory and commercial milestone payments along with royalties on sales of products arising from the collaborations
  • ViGeneron will optimize and validate in vitro therapeutic candidates for undisclosed target to treat inherited eye disease while Biogen has the right to add an additional reserved target within two years after the effective date
  • The companies will work together on the in vivo POC and will use ViGeneron’s vgAAV technology to efficiently transduce target cells via intravitreal injections

Click here ­to­ read full press release/ article | Ref: GlobeNewswire | Image: Fierce Biotech

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Amazon, AstraZeneca, Pfizer, Merck to Build $10M Digital Health Innovation Lab in Israel

Amazon, AstraZeneca, Pfizer, Merck to Build $10M Digital Health Innovation Lab in Israel
Rehovot Science Park

What You Should Know:

– Pfizer, AstraZeneca, Merck, and Teva, and Amazon Web Services (AWS) has been selected by the Israel Innovation Authority to establish an innovation lab in the fields of digital health and computational biology.

– The innovation lab located in the Rehovot Science Park will
receive a government budget of $10M over the next five years and is slated to
start operations in 2021.


Pfizer, AstraZeneca, Merck, and Teva, as well as the Israel Biotech Fund and tech giant
Amazon Web Services (AWS)— to establish an innovation lab in the fields of digital health
and computational biology. The companies were selected from a competitive bid process
conducted by the Israel Innovation
Authority
together with the National Digital Israel Initiative at the
National Digital Ministry.

The group will establish the Lab at the Rehovot Science Park
and invest in building a wet computational lab infrastructure in order to
assist early-stage entrepreneurs and startups to meet the challenges of the
healthcare industry, from the ideation stage to attaining proof of concept. The
Lab, scheduled to open in 2021, will be joining existing innovation labs as
part of the Israel Innovation Authority’s Innovation Lab Program.

$10M Operational Budget Over Next 5 Years

The innovation lab will operate on a government budget of
NIS 32 million ($10M USD), as well as additional funding from the partner companies.
The group will operate over the next five years, during which the Innovation
Authority, together with the National Digital Ministry, will finance 85% of a
total NIS 3 million budget for each startup that joins the lab, enabling them
to reach significant milestones in their technological development. The
Innovation Authority and National Digital Ministry will also participate in the
operating costs and in setting up the lab’s infrastructure.

Innovation Lab Focus Areas

The purpose of the Lab is to assist in the establishment and advancement of new startups developing innovative AI-based computational technologies aimed at discovering personalized solutions and treatments. The Lab will also help its startups — with the assistance of the lab partners and access they provide to their unique scientific know-how and leading experts — in developing groundbreaking medications and treatments. 

“This last year proved that the healthcare sector is rapidly transitioning to development and use of advanced technologies integrating engineering and biology, which has already led to more accurate results within a shorter time framework. This lab is part of the ‘Bio-convergence Strategy’ promoted by the Innovation Authority over the last year, aimed at establishing a successful, innovative ecosystem in the healthcare sector, which will serve as a proper basis for establishing innovative companies based on groundbreaking academic research performed in these areas in Israel. The expertise and vast experience of the lab partners will enable these companies to establish a significant, trailblazing industry in Israel,” said Aharon Aharon, CEO of the Innovation Authority.

Pfizer Report the US FDA’s Acceptance and Priority Review of sNDA for Lorbrena (lorlatinib) to treat (ALK)-Positive (NSCLC)

Shots:

  • The US FDA has accepted for Priority Review the sNDA is based on the pivotal CROWN study and is being reviewed by the FDA under its Real-Time Oncology Review (RTOR)
  • CROWN is P-lll, parallel 2-arm trial in which 296 previously untreated advanced ALK-positive NSCLC were randomized in ratio 1:1 to receive LORBRENA monotherapy (n=149) or XALKORI monotherapy (n=147). Result: The 1EPs is (PFS) based on the blinded independent central review (BICR) and 2EPs involve PFS based on OS, ORR, intracranial objective response, and safety
  • Lorbrena is a tyrosine kinase inhibitor (TKI) especially developed to inhibit tumor mutations and to penetrate the blood-brain barrier

Click here ­to­ read full press release/ article | Ref: Pfizer | Image: Michigan Health Lab

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Merck Signs a ~$1B Pact with Janux to Develop Cancer Therapies Using T Cell Engager Technology

Shots:

  • Janux to receive up to $500.5M/ target as upfront and milestones along with royalties on sales of product emerges from the collaboration, making a total deal value ~$1B. Merck will fund R&D performed under the agreement
  • Merck to get an exclusive WW license to products & IP developed from the collaboration
  • The focus of the collaboration is to leverage Janux’s TRACTr technology to engineer a novel, T cell engager candidates directed against two cancer targets selected by Merck

Click here ­to­ read full press release/ article | Ref: BusinessWire | Image: BusinessWire

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Minervax raises €47.4m in Series B funding round for GBS shot

Denmark’s MinervaX has raised €47.4 million (around $56 million) in a Series B funding round to take its novel group B streptococcus (GBS) vaccine into mid-stage clinical trials.

When and if the pandemic finally recedes there will still be an ongoing issue with a dearth of new antibiotics and a growing number of bacterial strains resistant to existing antibacterial medicines.

MinervaX is one company that wants to change this situation, which aims to prevent the spread of GBS infections using a vaccine instead of using an antibacterial agent.

On the back of phase 1b data the Copenhagen-based biotech said it had brought in new investors Sanofi Ventures, Adjuvant Capital and Industrifonden along with existing investors Novo Holdings, REPAIR Impact, Sunstone Life Science Ventures and LF Investment.

Proceeds will advance the clinical development of MinervaX’s novel GBS vaccine through phase 2 clinical trials, as well as manufacturing and regulatory preparation for phase 3.

GBS is responsible for nearly half of all life-threatening infections in newborns. MinervaX’s protein-only GBS vaccine targets pregnant women for the prevention of adverse pregnancy outcomes and life-threatening neonatal infections associated with GBS.

Globally, 15-25% of women are colonised with GBS, and they run the risk of transmitting the bacteria to their child in utero, during birth and / or during their first months of life.

GBS colonisation may lead to late-term abortions, premature delivery or stillbirth; and in newborn children may result in sepsis, pneumonia or meningitis, all of which carry a significant risk of severe morbidity, long-term disability or death.

The only preventive strategy available involves using intravenously delivered antibiotics and this does not comprehensively prevent infection in utero or reliably protect against late-onset infection in newborns.

Phase 1 data from 300 healthy females have so far shown a favourable safety profile, while generating high levels of long-lasting antibodies.

These are capable of mobilising the immune system against GBS bacteria and preventing invasion of epithelial and endothelial cell barriers.

Work began on a potential streptococcus vaccine in the 1980s and in 1996 a phase 1 trial provided a proof of concept that using polysaccharides and antigens from GBS could provide a strong enough immune response.

But there have been no GBS vaccines licensed since then, the Lancet pointed out in an editorial earlier this year.

The post Minervax raises €47.4m in Series B funding round for GBS shot appeared first on .

Genentech’s Ocrevus Shorter 2-Hour Infusion Receives the US FDA’s Approval for Relapsing & Primary Progressive Multiple Sclerosis

Shots:

  • The approval is based on ENSEMBLE PLUS study, which demonstrated similar frequency and severity of IRRs for 2hrs. Ocrevus infusion time vs conventional 3.5hrs in patients with RRMS. The initial dose is given as two 300mg infusions given 2wks. apart and a subsequent dose of single 600mg infusions were administered over a shorter, 2hrs. time
  • Results: frequency of IRRs post 600mg infusion (24.6% vs 23.1%), majority of IRRs were mild or moderate, and >98% resolved in both groups without complication
  • Ocrevus is a humanized mAb designed to target CD20-positive B cells and is the first and only therapy approved for both RMS and PPMS

Click here ­to­ read full press release/ article | Ref: Genentech | Image: Xconomy

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Chugai In-Licenses Roche’s Antibody Cocktail for COVID-19 in Japan

Shots:

  • Chugai get an exclusive development and commercialization agreement in Japan for Roche’s Ab cocktail of casirivimab and imdevimab to combat COVID-19
  • Earlier, Roche & Regeneron collaborated for the development & commercialization of Ab cocktail where Regeneron will distribute the treatment in the US while Roche will be lead manufacturing and distribution activities outside the US
  • The combination regimen is being studied globally in a P-II/III study for patients with COVID-19 who require hospitalization, in P-II/III clinical study for non-hospitalized patients with COVID-19, and P-III clinical study for prevention of infection in COVID-19 household contacts

Click here ­to­ read full press release/ article | Ref: Chugai | Image: Wikipedia

The post Chugai In-Licenses Roche’s Antibody Cocktail for COVID-19 in Japan first appeared on PharmaShots.

Astellas Collaborates with KaliVir to Develop and Commercialize VET2-L2

Shots:

  • KaliVir to receive $56M as upfront & other payments supporting the research & preclinical activities of VET2-L2 & is eligible to receive $307M & $271M as development, regulatory & commercialization for VET2-L2 & second product, respectively along with royalties on sales of each licensed product
  • The alliance integrates KaliVir’s expertise in the development of oncolytic viruses with Astellas’ capabilities in advanced drug development & its global business experience, enabling both parties to develop new immuno-oncology therapies
  • VET2-L2 (IV) is an oncolytic vaccinia virus that destroys cancer cells & activates anti-cancer immunity through the expression of therapeutic transgenes

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: BioSpectrum Asia

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Janssen Reports BLA Submission of Amivantamab to the US FDA for Metastatic NSCLC with EGFR Exon 20 Insertion Mutations

Shots:

  • The BLA is based on the P-I CHRYSALIS study assessing amivantamab as a monothx. and in combination with lazertinib in adult patients with advanced NSCLC
  • The company has established an EAP for patients in the US who may be eligible to obtain access to mivantamab during the review of the BLA
  • Amivantamab is an EGFR & MET bispecific Ab with the immune cell-directing activity that targets tumors with activating & resistance to EGFR & MET mutations & amplifications. Amivantamab has received the US FDA’s BTD in Mar’2020

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: Wypages

The post Janssen Reports BLA Submission of Amivantamab to the US FDA for Metastatic NSCLC with EGFR Exon 20 Insertion Mutations first appeared on PharmaShots.

Merck KGaA Collaborates with Artios Pharma for DNA Damage Cancer Therapies

Shots:

  • Artios to receive $30M up front & near-term milestones, ~$860M/ target as option fee along with royalties on sales of each commercialized product. Additionally, Artios has opt-in rights for joint development & commercialization of the programs
  • Merck has the right to opt into exclusive development & commercialization of compounds on up to 8 targets
  • The collaboration leverages Artios’ nuclease targeting discovery platform to jointly identify multiple synthetic lethal targets for precision oncology drug candidates while Merck KGaA will utilize its expertise and resources in the field of DDR

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: PSD

The post Merck KGaA Collaborates with Artios Pharma for DNA Damage Cancer Therapies first appeared on PharmaShots.

Swiss start-up Noema raises $59m to develop neurology drugs offloaded by Roche

Swiss biotech Noema has raised 54 million Swiss francs ($59m) to develop four neurological disorder drugs licensed in from Roche.

The company is developing four phase 2 drugs brought in from Roche after the big Swiss pharma decided somebody else should take the risk of developing them.

Roche, which decided the products were surplus to requirements in an already-packed pipeline, also received a shareholding in Noema, in exchange for rights to the four clinical-stage product-candidates.

Lead product is NOE-101, an mGluR5 inhibitor that is ready for phase 2b trials in two indications – for persistent seizures in Tuberous Sclerosis Complex and severe pain in Trigeminal Neuralgia.

The company is also preparing NOE-15, a PDE10A inhibitor for phase 2b testing to treat Tourette Syndrome.

It also has two other clinical stage assets – mGluR2/3 inhibitor NOE-109 and NOE-115, a triple reuptake inhibitor that are being evaluated in undisclosed indications.

The latest financing round was co-led by Sofinnova Partners, a European life sciences venture capital firm based in Paris, London and Milan, and Polaris Partners, a healthcare and technology investment firm based in the US.

The global consortium of new international investors includes Gilde Healthcare, Invus and BioMed Partners.

Noema was founded last year with a seed investment from Sofinnova partners and is led by CEO Luigi Costa, former CEO of haematology and oncology firm Nordic Nanovector.

He was also a senior figure at Onyx Pharmaceuticals, which was acquired by Amgen in 2014 and led the company’s international organisation and the launch of multiple myeloma drug Kyprolis outside the US.

The company also has the expertise of George Garibaldi as chief medical officer, a former Roche vice-president.

Costa said: “The successful licensing of these exciting clinical-stage product-candidates from Roche, together with our up-sized CHF54 million Series A financing, will enable Noema to reach value-creating development milestones with all four products.”

The post Swiss start-up Noema raises $59m to develop neurology drugs offloaded by Roche appeared first on .

Regeneron Collaborates with Penn to Explore Intranasal Delivery of COVID-19 Ab Cocktail via Gene Therapy Platform

Shots:

  • Penn allied with Regeneron to investigate Ab cocktail (casirivimab & imdevimab) to prevent COVID-19 infection when delivering intranasally via AAV vectors
  • The collaboration b/w Wilson and Penn’s GTP and Regeneron will have two phases. The first phase will include the validation of the effectiveness of Abs delivered via AAV in a large animal model challenge study. If successful, the research team will complete studies to support the filing of IND to the FDA
  • Regeneron’s Ab cocktail (casirivimab & imdevimab) is studied in clinical trials for the prevention of COVID-19 and has received the US FDA’s EUA in certain high-risk patients with mild to mod. COVID-19

Click here ­to­ read full press release/ article | Ref: Penn Medicine | Image: LaingBuisson News

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Moderna Amends its Agreement with UK Government for an Additional 2M Doses of COVID-19 Vaccine

Shots:

  • Moderna amended its current supply agreement with the UK govt. for an additional 2M doses of mRNA-1273 against COVID-19. The UK govt. has now secured 7M doses of mRNA-1273
  • The agreement reflects Moderna’s commitment to making its vaccine available in multiple countries. Moderna ramp up its global manufacturing to be able to deliver ~500M doses/yr & possibly ~1B doses/yr, beginning in 2021
  • The company is working with its strategic manufacturing partners, Lonza of Switzerland and ROVI of Spain, for manufacturing and fill-finish outside the US. Additionally, Moderna reported that the vaccine showed 94.5% efficacy

Click here ­to­ read full press release/ article | Ref: Businesswire | Image: Stat

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Online Live Team Pharma Forecasting Training Now Available

Working remotely can have its challenges, why not get together for a fun and rewarding learning experience and refresh your forecasting skills?

Following the success of J+D Forecasting’s face to face training, the content has been redesigned to make it suitable for live, online audiences.  There are two types of courses, type one is tailored to your objectives and delivered by experienced forecasting professionals via a sharing platform. Your team is interviewed prior to the training and the focus of the training is agreed in advance with you and your colleagues.

The second type of training allows you to choose from a selection of pre-set courses that are completed when you choose. The most popular independent courses are the Fundamentals of Forecasting and Oncology Forecasting courses.

The training is suitable for anyone involved in pharmaceutical forecasting who wishes to refresh or learn new skills. It is particularly useful for Forecasters, Marketeers, Analysts and Market Researchers.

In addition, trainees gain access to FC+ software, case studies and quizzes, plus reminder cards.
For further information get in touch: [email protected] or visit jdforecasting.com

The post Online Live Team Pharma Forecasting Training Now Available appeared first on .

Egle Identifies First Novel Regulatory T-cell Targets Under its Collaboration with Takeda

Shots:

  • Egle has achieved the first milestone in its research agreement with Takeda, signed in June’2020. Egle will validate novel tumor-infiltrating regulatory T-cell targets while Takeda will develop the potential therapies
  • Egle has leveraged its unique bioinformatic & translational capabilities to identify targets
  • Following the achievement of the target identification, Egle will receive an R&D milestone payment & equity funding from Takeda

Click here ­to­ read full press release/ article | Ref: Businesswire| Image: Businesswire

The post Egle Identifies First Novel Regulatory T-cell Targets Under its Collaboration with Takeda first appeared on PharmaShots.

Russia’s Sputnik V Demonstrates 91.4% Efficacy Against COVID-19

Shots:

  • The ongoing P-lll study involves assessing of Sputnik V vaccine vs PBO in 40,000 patients in a ratio (1:3) with COVID-19. The efficacy of the vaccine is 91.4%, based on the second interim analysis of data obtained 28 days after administering the first dose
  • Preliminary data from volunteers obtained 42days after the first dose (corresponds with 21days after the second dose) indicates the efficacy of the vaccine above 95%.
  • The data will be published by the Gamaleya Center team in peer-reviewed medical journals. Following the completion of P-lll clinical trials, Gamaleya Center will provide access to the full clinical trial report

Click here ­to­ read full press release/ article | Ref: Sputnik | Image: Anadolu Agency

The post Russia’s Sputnik V Demonstrates 91.4% Efficacy Against COVID-19 first appeared on PharmaShots.

Catamaran joins the CAR-NK fleet, raising $42m in first round

Catamaran Bio has weighed anchor with a $42 million first-round financing that will be used to pull its off-the-shelf natural killer (NK) cell therapies for cancer through early-stage development.

The Cambridge, Massachusetts-based biotech is the latest player in the emerging field of chimeric antigen receptor (CAR) NK cell therapies, which unlike the current generation of CAR-T therapies can be sourced from healthy donors, rather than patients themselves.

CAR-NK therapies also have the potential to be used to treat solid tumours, something that has so far eluded CAR-Ts, which to date have only been approved for blood cancers. Solid tumours tend to be a tougher treatment proposition for cell therapies, as they are harder to penetrate and are often swamped with immunosuppressive factors.

CAR-NK therapies consist of NK cells that have been modified with a CAR molecule, which allow them to bind to and attack a cancer cell.

Earlier this year, researchers at MD Anderson Cancer Centre in the US – a pioneer of CAR-NK – said they have achieved a 73% response rate with a CD19-targeting therapy derived from donated cells in patients with relapsed or refractory non-Hodgkin’s lymphoma and chronic lymphocytic leukaemia.

Catamaran’s cash injection comes just nine months after Catamaran was founded to build on research conducted by its scientific founders – George Washington University’s Catherine Bollard and University of Minnesota’s Branden Moriarty.

The other founders include Houman Ashrafian, Tim Harris and Kevin Pojasek of SV Health Investors, and Obsidian Therapeutics and Serien co-founder Vipin Suri, who will serve as Catamaran’s chief scientific officer.

Catamaran’s proprietary platform – called Tailwind – consists of a novel way to design and engineer improved CAR-NK cells using synthetic biology.

One element is the “architecture” or the CAR molecule, and Catamaran says it has novel structures in play that stimulate production of immune cytokine molecules by the CAR-NK cell, enhancing the cell-killing action.

Another is the delivery of molecule switches to CAR-NK cells, used to activate biological pathways that can help overcome the immunosuppressive microenvironment around tumours and improve recruitment of other elements of an immune response.

Finally, Tailwind includes a non-viral delivery system for engineering the CAR-NK cells based on transposons that make them easier and potentially cheaper to manufacture.

Viral vectors are limited in the size of genetic payloads they can deliver, but using transposons – a “jumping” DNA sequence that can change its position within a genome – sidesteps this issue and allow multiple CARs and switches to be delivered in one go.

Catamaran has two lead CAR-NK programmes at the lead optimisation stage, both of which target the same, undisclosed antigen that is found on both solid tumour and blood cancer cells. The lead programme is targeting a blood cancer.

“Catamaran is focused on expanding the frontier of cell therapies to treat solid tumours and provide transformative benefit to cancer patients,” said Suri.

“We are doing this by creating allogeneic cell therapies that harness the innate cancer-fighting power of NK cells and enhancing them with new biologically-powerful attributes from our leading-edge technologies,” he added.

Sofinnova Partners and Lightstone Ventures co-led the Series A, with SV Health Investors, Takeda Ventures and Astellas Venture Management also taking part.

Other groups developing CAR-NK therapies include Takeda, which has partnered with MD Anderson, as well as Artiva, Nkarta, Fate Therapeutics, oNKo-innate, Kuur Therapeutics, and ONK Therapeutics.

The post Catamaran joins the CAR-NK fleet, raising $42m in first round appeared first on .

Eli Lilly Signs an Exclusive Agreement with Precision BioSciences on Genome Editing Research

Shots:

  • Precision to receive $100M upfront, $35M as an equity investment and will receive $420M as milestones/ product along with royalties on sales of licensed products emerges from the collaboration
  • Precision will lead to pre-clinical research and IND-enabling activities while Lilly will lead clinical development and commercialization and have the right to select up to 3 additional gene targets. Precision can co-fund clinical development of one product in exchange for an increased royalty rate on co-funded product sales
  • The agreement will utilize Precision’s ARCUS genome editing platform for the development of in vivo therapies for genetic disorders, focusing on DMD and two other undisclosed gene targets

Click here ­to­ read full press release/ article | Ref: Lilly | Image: KMS Lighthouse

The post Eli Lilly Signs an Exclusive Agreement with Precision BioSciences on Genome Editing Research first appeared on PharmaShots.

Novartis Signs a License Agreement with Mesoblast to Develop and Commercialize Remestemcel-L for ARDS

Shots:

  • Mesoblast to receive $25M up front and $25M as equity investment with additional payments and royalties on achievement of development, regulatory and commercial milestones
  • Novartis to acquire the exclusive WW rights to develop, commercialize & manufacture remestemcel-L for ARDS & access to a cell-therapy based platform with WW rights to a range of potential indications. Novartis has the option to distribute remestemcel-L for GVHD (outside Japan)
  • Both parties have rights to co-fund development & commercialization for other non-respiratory indications. Remestemcel-L is currently being studied in COVID-19-related ARDS in an ongoing P-III study while Novartis plans to initiate a P-III study in non-COVID-19-related ARDS

Click here ­to­ read full press release/ article | Ref: Novartis | Image: Market Watch

The post Novartis Signs a License Agreement with Mesoblast to Develop and Commercialize Remestemcel-L for ARDS first appeared on PharmaShots.

VC firm SR One completes GSK spin-out, raising $500m

Trans-Atlantic biotech venture capital firm SR One has completed its spin-out from GlaxoSmithKline and closed its first fund with $500m in its coffers.

The VC built itself a considerable reputation after it was founded in 1985 and works with entrepreneurs and scientists to build biotechnology companies.

GSK is the largest investor in the independent fund, which said it is the largest first-time VC fund to close in 2020 focused on US and European biotechs.

CEO Simeon George will lead the company’s investment team, bringing more than a decade’s worth of experience in the sector.

George has been with the fund since 2007 and established its San Francisco office in 2010.

He earned his MD and MBA from the University of Pennsylvania School of Medicine/Wharton and BA from Johns Hopkins University.

Previously, he worked in management consulting (Bain & Co.) and investment banking (Goldman Sachs) and has led some of SR One’s highest profile investment deals.

These include CRISPR Therapeutics and Principia Biopharma, which was recently acquired by Sanofi for $3.7 billion, Turning Point Therapeutics, Progyny and Nkarta Therapeutics, which he co-founded.

David Redfern, chief strategy officer at GSK, said: “Since inception, SR One’s mandate has been to deliver financial returns by investing in innovative biotechnology companies.

“Following SR One’s spin-out from GSK and establishment as an independent fund management business, GSK has remained a committed investor in SR One’s new independent fund, alongside a diversified and top tier investor base.

“The close of the fund at the hard cap and its over-subscription by global investors underscore the team’s abilities and strong track record.”

CEO Simeon George said: “Our spin-out from GSK and successful raise of a new independent fund provide a foundation for SR One’s next chapter, enabling us to scale our investment strategy and build upon our track record of success.”

It’s been a busy time for life sciences VC, with the likes of Canaan Partners, Atlas Venture creating new funds amid the investment boom in life sciences amid the COVID-19 pandemic.

The post VC firm SR One completes GSK spin-out, raising $500m appeared first on .

Sanofi’s Supemtek (quadrivalent recombinant influenza vaccine) Receives the EC’s Approval to Prevent Influenza

Shots:

  • The approval is based on two P-III studies assessing the safety and efficacy of Supemtek (quadrivalent recombinant influenza vaccine) in 10,000 patients with influenza aged > 18yrs. Supemtek is 1st and only recombinant influenza vaccine approved in the EU
  • The P-III efficacy study demonstrated improved protection against influenza compared to standard-dose influenza vaccine and reduced the risk of influenza by an additional 30% in adults aged ≥50yrs.
  • Supemtek contains three times more antigen than both egg-based and cell-based standard-dose vaccines. Supemtek is also approved in the US under the tradename Flublok Quadrivalent

Click here ­to­ read full press release/ article | Ref: Sanofi | Image: Sanofi

The post Sanofi’s Supemtek (quadrivalent recombinant influenza vaccine) Receives the EC’s Approval to Prevent Influenza first appeared on PharmaShots.

TGFB for Immuno-Oncology Drug Development Summit

Are you interested in finding the next breakthrough in immuno-oncology preclinical or clinical development?

Recent scientific, clinical breakthroughs and high-profile industry deals have reignited the race to find the next blockbuster TGF-ß inhibitor for immuno-oncology applications.

As such, the TGFß for Immuno-Oncology Drug Development Summit (January 26-28) is the ONLY industry-focused meeting dedicated to pharma, biotech, and academia who will share their latest data, best practices, and top tips to expedite TGF-beta candidates into the clinic in a safe and efficacious manner.

With over 21 expert speakers presenting across 3 days packed full of content, this is your definitive guide to tame the TGF-beta double-edged sword and navigate a narrow therapeutic window, enhance tumor suppression, and maximize therapeutic potential in immuno-oncology – you won’t want to miss it!

Take a look at the full program here

Here’s a sneak peek into the world-class speaker faculty:

  • Shannon Turley, Senior Director, Cancer Immunology, Genentech
  • Rik Derynck, Professor – Departments of Cell, Tissue Biology & Anatomy, University of California San Francisco
  • Thomas Schurpf, Associate Director, Scholar Rock
  • Olaf Christensen, Vice President, Head of Bintrafusp alfa, Global Development, R&D, EMD Serono
  • Paul Rennert, President & Chief Scientific Officer, Aleta Biotherapeutics
  • Sam Shrivastava, Chairman & Chief Executive Officer, Venn Therapeutics
  • Vuong Trieu, Chairman & Chief Executive Officer, Oncotelic Inc
  • Christopher Heery, Chief Medical Officer, Precision BioSciences

Download your digital event guide here to access the full speaker faculty and conference agenda.

How can this get any better I hear you ask? Well, through our specialized digital platform, you can enjoy the full conference experience all from the comfort of your own home (without the bad conference coffee and awkward encounters at the buffet table). Using our algorithm get matched with fellow attendees and speakers for meaningful networking opportunities.

For more information visit www.tgf-beta-summit.com or email us at [email protected].

The post TGFB for Immuno-Oncology Drug Development Summit appeared first on .

J&J and US Government Amends their Agreement for the Next Phase of COVID-19 Vaccine Development

Shots:

  • J&J and the US Department of Health and Human Services have expanded an agreement to support the next phase of COVID-19 vaccine candidate research and development
  • Janssen will commit ~$604M while BARDA will commit ~$454M to support the ongoing P-lll ENSEMBLE study assessing Janssen’s JNJ-78436735 as a single-dose in ~60,000 patients globally
  • J&J affirmed its commitment to develop and test its vaccine candidate in accordance with high ethical standards and sound scientific principles, as outlined in a pledge made by 9 vaccine manufacturers in early 2020

Click here­ to­ read full press release/ article | Ref: PR Newswire | Image: Courier Journal

The post J&J and US Government Amends their Agreement for the Next Phase of COVID-19 Vaccine Development first appeared on PharmaShots.

Novavax Collaborates with Commonwealth of Australia to Supply 40M doses of NVX-CoV2373 for COVID-19

Shots:

  • Novavax has signed a non-binding Heads of Terms document with the Australian Government to supply 40M doses of NVX-CoV2373 for the Australian community
  • The delivery will start as early as H1’21, following the completion of P-III study and the TGA’s approval of the vaccine. The vaccine regimen is expected to require two doses per individual, administered 21 days apart.
  • NVX-CoV2373 is evaluated in P-ll trial in the UK and 2 ongoing P-ll studies that began in Aug’2020, a P-llb trial in SA, and a P-l/ll continuation in the US and Australia. Additionally, Novavax has multiple agreements for the supply of NVX-CoV2373 directly to the US, UK, Canada, and through partnerships, supply to Japan, South Korea, and India

Click here to­ read the full press release/ article | Ref: GlobeNewswire | Image: MediCircle

The post Novavax Collaborates with Commonwealth of Australia to Supply 40M doses of NVX-CoV2373 for COVID-19 first appeared on PharmaShots.

CStone Signs a License Agreement with LegoChem for LCB71 to Treat Multiple Cancer Indications

Shots:

  • LCB to receive $10 M as upfront, and up to $353.5M as cumulative milestone payments along with royalties on sales of LCB71. CStone get an exclusive global right to lead the development and commercialization of LCB71 outside the Republic of Korea
  • The collaboration adds the first ADC to CStone’s development pipeline, bolstering its precision medicine franchise with a new modality
  • LCB71 is a pre-clinical ADC targeting ROR1, having the potential to treat multiple cancer indications and has demonstrated efficacy and reduced toxicity in preclinical studies

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: Investopedia

The post CStone Signs a License Agreement with LegoChem for LCB71 to Treat Multiple Cancer Indications first appeared on PharmaShots.

BMS Signs a Five-Year Agreement with Insitro to Develop Therapies for ALS and Frontotemporal Dementia

Shots:

  • Insitro to receive $50M as up front, $20M as near-term operational milestones and is eligible to receive ~$2B+ as discovery, development, regulatory and commercial milestones along with royalties on sales of the therapies
  • BMS will lead the clinical development, regulatory submissions, and commercialization activities. Insitro will apply its insitro Human (ISH) platform, to create iPSC derived disease models for ALS and FTD
  • Insitro will apply ML-enabled therapeutics discovery capabilities to advance programs while BMS to get an option to select several targets identified by insitro to advance through clinical development and commercialization

Click here to­ read full press release/ article | Ref: Businesswire | Image: Medium

The post BMS Signs a Five-Year Agreement with Insitro to Develop Therapies for ALS and Frontotemporal Dementia first appeared on PharmaShots.

GSK Presents Results of Maternal & Older Adults RSV Vaccines at IDWeek 2020

Shots:

  • GSK reported that its RSV vaccines for maternal immunization (GSK3888550A) and older adults (GSK3844766A) were well-tolerated and highly immunogenic in P-I/II clinical studies. Both the candidate vaccines contain a recombinant RSVPreF3, that triggers the required immune response
  • The GSK3844766A was first tested in 48 healthy adults (18-40yrs.) & then in 1005 healthy older adults (60-80yrs.) with different dosages of antigen & adjuvant. The interim data 1mos. post-immunization elicited a robust humoral and cellular immunity while the vaccine includes AS01 adjuvant system to boost the immune response
  • GSK3888550A was tested with 3 different doses vs PBO in 502 healthy non-pregnant women over monthly visits (day 8, 31 & 91 post immunization). The study results demonstrated that vaccine rapidly boost pre-existing immunity at all dose levels & @day8 it showed a 4-fold increase in RSV-A and RSV-B neutralizing Abs titers. P-III studies of both the vaccines are expected to initiate in the coming months

Click here ­to­ read full press release/ article | Ref: GSK | Image: Reuters

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Novo Nordisk Signs a License Agreement with Chugai for Antibody Engineering Technologies

Shots:

  • Chugai will receive an upfront, development milestone and royalties if the compound is launch as an approved Ab drug. Additionally, Chugai will receive a fee for technology access
  • Novo Nordisk to get the rights to use several Chugai Ab engineering technologies for their research activities and optional right for the development and marketing of therapeutic Abs
  • Novo Nordisk will utilize Chugai’s Ab engineering technologies targeting the unmet medical needs and create novel medicines

Click here ­to­ read full press release/ article | Ref: Chugai | Image: Peter Boyle Solicitors

The post Novo Nordisk Signs a License Agreement with Chugai for Antibody Engineering Technologies first appeared on PharmaShots.

Babyscripts Forms Commercial Partnership with Roche to Develop RPM Programs for Pregnancy

Babyscripts Forms Commercial Partnership with Roche to Develop RPM Programs for Pregnancy

What You Should Know:  

Babyscripts today announced a commercial partnership with
Roche Diagnostics, a division of the world’s largest biotech company and a
global pioneer in pharmaceuticals and diagnostics. 

– Roche will partner with Babyscripts on the
development of Babyscripts’ remote patient monitoring (RPM) programs to
leverage groundbreaking data science through the next generation of RPM in
pregnancy. 


Babyscripts, a
Washington D.C.-based virtual care platform for managing obstetrics, today
announced a commercial partnership with Roche
Diagnostics
, a division of the world’s largest biotech company and a
global pioneer in pharmaceuticals and diagnostics. Roche Diagnostics and Babyscripts will collaborate on the next generation of
digital and diagnostic combinations in women’s health.

Commercial Partnership to Power Next-Generation of RPM in
Pregnancy

Under the terms of this collaboration,
Roche will partner with Babyscripts on the
development of Babyscripts’ remote patient
monitoring (RPM) programs to leverage groundbreaking data science through the
next generation of RPM in pregnancy. These programs will be focused on solving
issues of blood pressure-related complications through RPM, such as prenatal
hypertension. Babyscripts participated in Startup
Creasphere
, Roche’s digital health accelerator
program, which was instrumental in initiating this collaboration.

Babyscripts Virtual
Care Platform Background

Babyscripts has spent
the last six years building a clinically-validated, virtual care platform to
allow OBGYNs to deliver a new model of prenatal and postpartum care. Using
internet-connected devices for remote monitoring, Babyscripts offers
risk-specific experiences to allow providers to manage up to 90% of pregnancies
virtually, allowing doctors to detect risk more quickly and automate elements
of care.

“Roche’s investment in Babyscripts solutions is a tremendous validation of our vision for improving maternal care, and an example of the kind of strategic collaboration essential to moving the needle on outcomes,” said Juan Pablo Segura, co-founder and President of Babyscripts. “Roche’s vast expertise in the field of women’s health diagnostics and clinical science combined with our on-the-ground experience in the virtual maternal health space is going to prove a game changer for rethinking how we approach prenatal and postpartum care.”

Ori Biotech Lands $30M for Cell and Gene Therapy Manufacturing Platform

Biotech Startup Ori Biotech Lands $30M for Cell and Gene Therapy Manufacturing Platform

What You Should Know:

– Biotech startup Ori Biotech raises $30M in Series A
funding to scale its cell and gene therapy (CGT) manufacturing platform.

– Ori Biotech helps pharmaceutical and biotech companies
develop and manufacture cell and gene therapies. Its patented technology aims
to reduce the manufacturing cost of these life-saving treatments by up to 80%,
allowing them to be more widely accessible for patients.


Ori Biotech Ltd (Ori),
a leading innovator in cell and gene therapy (CGT) manufacturing, today
announced the successful close of a $30 million Series A financing round,
bringing the company’s total funding to date to $41 million. The Series A round
was led by the experienced life sciences investment team at Northpond Ventures, a leading global
science, medical, and technology-driven venture fund, alongside Octopus Ventures, a leading European
venture fund. Northpond and Octopus invested alongside significant support from
Ori’s existing institutional investors, Amadeus Capital Partners, Delin Ventures, and Kindred Capital.

The Future of Cell and Gene Therapy Manufacturing

Founded in 2015 by Dr. Farlan Veraitch and Professor Chris Mason, Ori Biotech is a London and New Jersey-based cell and gene therapy (CGT) manufacturing technology company. Ori has developed a proprietary, flexible manufacturing platform that closes, automates, and standardizes manufacturing allowing therapeutics developers to further develop and bring their products from pre-clinical process development to commercial-scale manufacturing. The mission of the Ori platform is to fully automate CGT manufacturing to increase throughput, improve quality, and decrease costs in order to enable patient access to this new generation of life-saving treatments.

The new funding will be used to help bring Ori’s innovative
manufacturing platform to the market. The Ori platform delivers scalable
solutions to flexibly address the critical clinical and commercial
manufacturing needs of CGT developers.

“Closing a significant Series A round, during these uncertain times, further validates Ori’s disruptive approach to fully automating cell and gene therapy manufacturing to increase throughput, improve quality, and decrease costs,” said Jason C. Foster, CEO of Ori Biotech. “We are excited to work with our top tier investors and development partners to bring our platform to market as fast as possible to achieve our mission of enabling patient access to life-saving cell and gene therapies.”

Regeneron’s Inmazeb (atoltivimab, maftivimab, and odesivimab) Receives the US FDA’s Approval as the First Treatment for Ebola

Shots:

  • The approval is based on the PALM trial assessing Inmazeb vs Zmapp and remdesivir in 681 adult and pediatric patients including newborns of mothers who have tested positive for the infection. The study demonstrated 1EPs of mortality @28days (33.5% vs 51.3%) and 2EPs of reduction in days until the virus was undetectable in the bloodstream
  • As per the agreement signed in Jul’2020, Regeneron will deliver a number of Inmazeb treatment doses for 6yrs. to the BARDA.
  • Inmazeb is a triple antibody cocktail consisting of 3 mAbs (atoltivimab, maftivimab & odesivimab, 50 mg each /kg) that bind to different, non-overlapping epitopes on Zaire ebolavirus glycoprotein

    Click here to­ read the full press release/ article | Ref: PR Newswire | Image: Stat

The post Regeneron’s Inmazeb (atoltivimab, maftivimab, and odesivimab) Receives the US FDA’s Approval as the First Treatment for Ebola first appeared on PharmaShots.

Roche Signs a License Agreement with Dyno to Develop AVV Gene Therapy for ~$1.8B

Shots:

  • Dyno to receive upfront and is eligible to receive ~$1.8B milestones including development and commercial milestones along with royalties on any product emerges during the collaboration
  • Dyno will be responsible for the design of novel AAV capsids with improved functional properties for gene therapy while Roche and Spark will conduct preclinical, clinical, and commercialization activities for the products using the novel capsids
  • The collaboration leverages Dyno’s CapsidMap platform for the development of next-generation AAV vectors for CNS diseases and liver-directed therapies for the portfolio of both Roche and Spark

    Click here to­ read the full press release/ article | Ref: Dyno Therapeutics | Image: Oncology Nurse Advisor

The post Roche Signs a License Agreement with Dyno to Develop AVV Gene Therapy for ~.8B first appeared on PharmaShots.

Inhaled and Intranasal Drug Delivery: A Deeper Look into Service Providers Landscape

The techniques used for the drug delivery are found to be have an enormous impact on the efficacy of the treatment. In fact, the slow progression of the efficacy, has suggested the need of different approaches for the effective delivery of drug to the target area, along with the optimal bioavailability. Over the years, several drug delivery systems have been introduced to the market. However, the innovators present in the pharmaceutical domain have been continuously investing in the new advancements to minimize the unwanted toxicities and to improve the efficacy of the treatment. Amongst these, one such non-invasive approach for the drug delivery is the inhaled and intranasal route of administration.

Pulmonary route of drug delivery has always been an area of interest for the investors present in this domain. It offers the absorption of drugs through lungs, which are used for the local deposition or for systemic delivery. This is only possible because of the large surface area offered by lungs for the absorption of drugs and the ability to overcome the first-pass metabolism. In addition, it has been reported that, several local respiratory and systemic diseases can be treated well with the afore-mentioned type of route of delivery. Example of such diseases include, asthma, local infectious diseases, pulmonary hypertension, diabetes, depression and migraine. Further, there are many biotherapeutics as well which are currently injected intravenously and can be effectively delivered by the pulmonary route. These include, growth hormones, glucagon and insulin.

Companies Offering Inhaled and Intranasal Drug Product and Drug Delivery System  Related Services

Owing to the increasing pipeline of these drugs and the associated manufacturing complexities, the developer companies are relying on the contract service providers, available in this domain. These service providers tend to have enough capabilities and experience, to offer the services related to drug product and drug delivery systems.

Inhaled and Intranasal Drug Delivery

During our research, we came across more than 110 players, which claim to offer services related to inhaled and intranasal drug products. As per our analysis, majority of these players have their inhaled and intranasal related manufacturing facilities located in Europe, followed by North America.

Further, we also came across around 20 additional players, which claim to offer services related to inhaled and intranasal drug delivery systems. As per our analysis, majority of the companies have the capability to offer services related powder and aerosol-based formulations. Of these, most of the service providers offered development services for the respective drug delivery systems.

A Deeper Look into Service Providers  Landscape

Which Type of Deals are being Inked in this Domain?

In the last five years, several players have collaborated to enhance their inhaled / intranasal drug and drug delivery system portfolio. In fact, the maximum number of collaborations (20%) were inked in 2017 and 2016; of these, 33% were development and manufacturing agreements. Further, in 2020 (till June), 16% collaborations were inked between different stakeholders. Of the total, close to 22% collaborations inked during this period were related to development agreements, followed by acquisitions (19%) and manufacturing agreements (17%).

Intranasal Drug Delivery Systems

What is the Current Demand for Inhaled / Intranasal Drug Delivery Systems (in terms of number of units)?

Over the past decade, the number of inhaled and intranasal drug delivery systems available in the market have increased significantly. In fact, the increase in demand for these drug delivery systems, is reported to be driven by the prevalence of asthma and COPD. In order to address this increasing demand for inhaled and intranasal drug delivery systems, developer companies are continuously working towards the development of more sophisticated and easier to use drug delivery systems.

Intranasal Drug Product and Drug Delivery System Contract Service Providers Market

Likely Growth of the Inhaled / Intranasal Drug Product and Drug Delivery System Contract Service Providers Market

During our research, we estimated the market under conservative, base and optimistic scenarios. As per the base case forecast scenario, the market for inhaled and intranasal contract services market is estimated to be worth over USD 20 billion by 2030, growing at an annualized rate of over 7% in the given time period.

Growth of the Inhaled

To get a detailed information on the key players, partnership activity, current and future demand in this domain and the likely market evolution.

Check out the report here.

Inhaled and Intranasal Products: Contract Service Providers Market (Focus on Drugs and Drug Delivery Systems), 2020 – 2030

You may also be interested in the following titles:

  1. STING Pathway Targeting Therapeutics and Technologies
  2. Point-of-Care Diagnostics Market for Infectious Diseases by Indication
  3. Single-cell Sequencing Services and Technologies Market, 2020-2030

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J&J to Supply EU with up to 400M Doses of its COVID-19 Vaccine

Shots:

  • EC has approved an advance purchase agreement in which the Janssen will supply 200 M doses of thw COVID-19 vaccine candidate to EU member states following approval from regulators. Additionally, the EU member states have an option to secure up to 200M additional doses
  • The agreement follows the conclusion of exploratory talks with the EC. Apart from the agreement, J&J plans to allocate up to 500M vaccine doses toward international efforts for ensuring access in lower income countries, with delivery beginning in mid-2021, following approval
  • J&J is evaluating a single dose regimen in P-III ENSEMBLE study initiated in Sept’2020 and plans the initiation of P-III study with two-dose regimen later this year

    Click here ­to­ read full press release/ article | Ref: J&J | Image: Law.com

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Merck Signs an Out-Licensing Agreement with Novartis for M6495 (Anti-ADAMTS5 Nanobody) for Osteoarthritis

Shots:

  • Merck to receive an € 50M upfront payment and € 400M development and commercial milestones and royalties on future net sales. Novartis will hold full responsibility for the development and commercialization of the M6495 program
  • Two P-I studies were completed with M6495 where NCT03224702 in healthy volunteers demonstrated safety and tolerability and reduction of ARGS levels at single doses (n=54) and NCT03583346 targets inhibition of ARGS with dosing every other week in OA patients    
  • M6495 is being developed to be self-administered via SC injections to maintain structural integrity of knee joint and reduce pain. M6495 was originally jointly developed by Merck and Ablynx as part of a joint discovery and development agreement in 2011

Click here to­ read full press release/ article | Ref: Merck | Image: Stem Cells Transplant Institute

The post Merck Signs an Out-Licensing Agreement with Novartis for M6495 (Anti-ADAMTS5 Nanobody) for Osteoarthritis first appeared on PharmaShots.

Moderna’s mRNA-1273 COVID-19 Vaccine Demonstrate Immune Responses in Older Adults

Shots:

  • Moderna reported the publication of the second interim analysis of the open-label P-I study of mRNA-1273 in the NEJM. The study evaluated a 2dose vaccination schedule of mRNA-1273 given 28 days apart in 40 adults across two dose levels (25/100µg) in two age cohorts (56-70/ 71+) and reports results @Day 57 (1mos. following the second dose)
  • mRNA-1273 induced consistently high levels of pseudovirus neutralization Ab titers in all participants, elicited Th1-biased CD4 T cell responses across all age group, neutralizing Ab titers and T cell responses is consistent with reported in younger adults, both the doses were well tolerated
  • Results were consistent using 3 live virus assays. Additionally, the US government has agreed to purchase 100M doses of mRNA-1273, with an option to purchase an additional 400M dose

Click here ­to­ read full press release/ article | Ref: Moderna | Image: Stat

The post Moderna’s mRNA-1273 COVID-19 Vaccine Demonstrate Immune Responses in Older Adults first appeared on PharmaShots.

Taysha Gene Therapies’ TSHA-101 Receives the US FDA’s Orphan Drug Designation and Rare Pediatric Disease Designation for GM2 Gangliosidosis

Shots:

  • The US FDA has granted ODD and RPD to the Taysha Gene Therapies’ TSHA-101 for GM2 Gangliosidosis. The company expects the therapy to enter the clinic by the end of 2020
  • The US FDA’s two designations demonstrated the strength of the translational data package supporting TSHA-101 for GM2 Gangliosidosis
  • TSHA-101 is an AAV9-based gene therapy, currently under development for rare, neurodegenerative disease that causes a progressive dysfunction of the CNS

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: Nordic Life Science

BioNTech and Fosun Pharma to Supply ~10M Doses of COVID-19 Vaccine to Hong Kong and Macao

Shots:

  • BioNTech and Fosun collaborated to supply 10M doses of their BNT162 mRNA-based vaccine candidate against COVID-19 to Hong Kong SAR and Macao SAR, once approved
  • Fosun Pharma has signed the Letter of Intent with Jacobson for contemplated distribution of 10M doses of a vaccine targeting COVID-19 in the Chinese market
  • On Mar 13, 2020, the companies collaborated to jointly develop and commercialize the vaccine in Mainland China, Hong Kong, and Macau SAR and the Taiwan region. The P-I study of BNT162b1 has been initiated in China  and enrolled 144 participants

Click here ­to­ read full press release/ article | Ref: BioNTech | Image: StraitTimes

BeiGene Signs an Exclusive License Agreement with Singlomics for Neutralizing COVID-19 Antibodies

Shots:

  • Singlomics to receive upfront and is eligible to receive regulatory & commercial milestones along with royalties on sales of products. BeiGene get an exclusive global right (Ex-China) to develop & commercialize its preclinical assets (DXP-593 and DXP-604), as well as for a series of Ab sequences targeting COVID-19
  • The companies plan to initiate P-I study enrolling up to 30 healthy subjects in Australia in Sept’2020 and anticipates the initiation of enrollment in P-I/II study in patients with mild to moderate COVID-19 by early Oct’2020
  • DXP-593 and DXP-604 are SARS-CoV-2 neutralizing Ab drug candidates identified by high-throughput single-cell RNA and VDJ sequencing of antigen-enriched B cells from over 60 convalescent patients. The candidates elicited strong neutralization potency in its preclinical testing

Click here ­to­ read full press release/ article | Ref: BeiGene | Image: OutSourcing Pharma

COVID-19 is causing a renaissance in the UK biotech sector, we must ensure it lasts

Despite the UK’s world class research output and the many start-ups successfully spinning out from its academic institutions, in recent years UK biotech companies have struggled to access the capital they need to scale up and make their mark on the industry.

The COVID-19 pandemic has brought about a radical transformation, with investors now eager to fund companies involved in the fight against the virus. To ensure this renaissance endures, stakeholders such as the UK government and investors themselves must ensure the right regulatory and capital foundations are laid down.

A world-class science and start-up ecosystem

There is certainly no shortage of high-quality research or scientific output in the UK. The Biotechnology and Biological Sciences Research Council (BBSRC), part of UK Research and Innovation (UKRI), works with universities, research organisations, businesses, charities, and government to develop a supportive ecosystem. The UK is home to three of the top ten universities in the world for life sciences – Oxford, Cambridge and UCL – and UK research accounts for 12% of all life sciences academic citations globally, with the UK’s share of the top 1% of these standing at 18%. Other university cities such as Nottingham and Cardiff are also prominent.

Similarly, the UK also performs well at transferring academic knowledge into innovative start-ups. Some 42% of UK biotech companies have been spun‑out from academic institutions and, according to the latest report from Global University Venturing, the UK is home to five of the top ten universities in the world by value of capital raised via their spin-out start-ups.

Companies have struggled to access intermediate capital

However, companies in the sector have tended to stall prior to achieving scale. The common challenge is undertaking lengthy and capital-intensive phase II/III clinical trials. UK companies suffer from a limited pool of available capital and investors able to accept the risks and time required for commercialisation. Unable to move to the next stage of growth, many companies are often sold, willingly or unwillingly, before they have achieved their objectives.

Investment trends in the US influence investor appetite in the UK. Over the past five to ten years US investors have focused on technology and internet companies, and relatively little on new biotech or pharmaceutical companies. Regulatory pressures, lengthy drug development times, and the fact that drug prices have become politicised have raised risks and cut revenue projections, leading to the biotech sector falling out of fashion. In the UK, structural problems of the AIM market have compounded these problems by driving institutional investors away from relatively illiquid shares.

COVID-19 sparks change

The pandemic has changed the situation, highlighting the importance of having a vibrant and strong UK life sciences sector that can provide COVID-19 vaccines, therapies and tests to help society return to work and get the economy back on track.

Certainly, the supply of capital has dramatically increased. Large amounts of government funding became available, with Oxford University’s Jenner Centre and its spin-out company, Vaccitech, for example, having received £65 million of public funding from the UK Government for development of its viral vector ChAdOx1 vaccine and to support its clinical trials.

The strategic importance of the biotech sector has attracted a flood of institutional, generalist and retail investors as they reallocate capital away from sectors such as retail, leisure and travel, which have suffered in the lockdown. As a result, the FTSE 350 Pharmaceuticals & Biotech index hit all-time highs in May.

Moreover, the range of companies benefiting from investor interest has not been limited to those developing a vaccine. To use the analogy of vaccine discovery being akin to striking gold during the Klondike Rush of the late nineteenth century, there are a raft of companies profiting from selling ‘picks and shovels’ – whether this is developing associated treatments and diagnostics, or manufacturing devices.

For example, if a company is carrying out clinical trials, then a clinical research organisation is needed to run them. If one is recruiting patients, then data management and other ancillary services are required. Vaccine trials in Oxford may make the headlines, but in the background are the people and companies providing the hardware and laboratories. All this has combined to inspire a renaissance in the sector.

“While some valuations in the US might have edged too high, in the UK that certainly is not yet the case. We are currently seeing a trend of US investors coming and buying what they see as undervalued UK biotechs”

Two key trends underpin the sector’s resurgence

Two important trends have also emerged during this sector resurgence. The first is that the development of vaccines is utilising cutting edge technologies.

Conventional vaccines introduce an inactivated sample of a disease to patients with the aim of stimulating an immune response. Today researchers are attaching only a portion of the DNA or mRNA of the virus to a harmless molecule. This precision has significant advantages in efficacy and production.

Because they are relatively new, these techniques have not yet yielded licensed products for human use. Therefore, a successful COVID-19 vaccine developed in this manner would represent a huge leap forward for the industry and demonstrate biotech’s ability to solve some of society’s biggest problems.

Another trend is a tremendous level of repurposing of existing IP and production capacity – often from areas that have been struggling for years – towards COVID-19 related causes. Scancell Holdings, for example, is currently producing a COVID-19 vaccine, but is doing so by repurposing expertise gained from developing a vaccine against melanoma.

Indeed, many companies that have found they can apply IP and business capacity to fighting the virus have seen their share prices rocket – UK small-cap Synairgen, for instance, saw its shares soar more than 1000% between the start of the year and mid-April as investors piled in on its plans to develop a potential treatment for coronavirus.

Nevertheless, while some valuations in the US might have edged too high, in the UK that certainly is not yet the case. Indeed, we are currently seeing a trend of US institutional investors coming in to buy what they see as undervalued UK biotech companies.

Paving the way for lasting change

So, what needs to happen to ensure the recent resurgence of the UK biotech sector does not recede once the pandemic is over? One approach would be to continue to provide government funding to underpin private investment in the sector. A more enlightened approach would be to address investors’ underlying concerns by, for example, reviewing the formats of clinical trials and the associated regulatory approval process, which were designed decades ago. If these discourage investment in the sector, are they still fit for purpose?

If we get it right, the prize is great. The outcome could be a UK that is resilient to future threats to public health, a world-leader in supporting the development of new life-changing medical treatments, diagnostics and devices, and a country that is building an innovation-led economy to create future prosperity.

 

About the author

Andrew Boyle is CEO of LGB & Co.

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AstraZeneca Initiates P-I Study of AZD7442 Against COVID-19

Shots:

  • The first participants have been dosed in a P-I trial of AZD7442 to assess safety, tolerability, and PK of the combination mAbs in up to 48 healthy participants aged 18-55 yrs. in the UK. The study is funded by DARPA
  • If AZD7442 proves to be tolerated and has a favorable safety profile in the trial, AstraZeneca will progress it into larger P-II & P-III trials to evaluate its efficacy as a preventative and treatment approach against COVID-19. The company anticipates the results of P-I study in H2’20
  • AZD7442 is a combination of two mAbs derived from convalescent patients with SARS-CoV-2 infection, discovered by Vanderbilt University Medical Center and licensed to AstraZeneca in Jun’2020. AstraZeneca optimized the mAbs with half-life extension and reduced Fc receptor binding

Click here to­ read full press release/ article | Ref: AstraZeneca | Image: Outsourcing Pharma

Merck’s Keytruda (pembrolizumab) Receives Two New PMDA’s Approvals in Japan

Shots:

  • The first approval is for certain ESCC patients, which is based on P-III KEYNOTE-181 trial assessing Keytruda vs CT in patients with recurrent or metastatic ESCC whose tumors expressed PD-L1 (CPS ≥10). The study demonstrated mOS (10.3 vs 6.7mos.)
  • Additionally, Keytruda received approval for use at an additional recommended dosage of 400mg, q6w, IV over 30 minutes across all adult indications, including both monothx. and combination therapy
  • The approval for q6w dosing regimen is based on PK modeling and exposure-response analyses & was supported by an interim analysis of KEYNOTE-555 from a cohort of patients (Cohort B) treated with Keytruda (400mg, q6w). With the approvals, Keytruda has 13 indications across seven tumor types plus MSI-H tumors in Japan

Click here ­to­ read full press release/ article | Ref: Merck | Image: Biospace

Novartis’ Triple Regimen Fails to Meet the Primary Endpoint in P-III COMBI-i Study for Advanced Melanoma

Shots:

  • The P-III study involves assessing of spartalizumab (PDR001) + Tafinlar (dabrafenib) and Mekinist (trametinib) vs PBO + Tafinlar and Mekinist in previously untreated patients with unresectable or metastatic BRAF V600 mutation-positive melanoma
  • The study was conducted in three parts while today’s results are from part 3 of the trial. The study did not meet its 1EPS of investigator-assessed progression-free survival
  • Spartalizumab is mAb targeting PD-1 receptor while Tafinlar and Mekinist are prescription medicines, used in combination to prevent melanoma

Click here ­to­ read full press release/ article | Ref: Novartis | Image: CNBC

ReiThera Reports First Patient Dosing with its COVID-19 Vaccine Candidate in Italy

Shots:

  • The first healthy volunteer has been dosed in a P-I study of GRAd-COV2 against COVID-19 which is conducted by the Lazzaro Spallanzani National Institute for Infectious Diseases under the sponsorship of ReiThera
  • The P-I study will evaluate the safety & immunogenicity of GRAd-COV2 in 90 healthy volunteers divided equally into two age cohorts: 18-55yrs. and 65-85yrs. with participants to be monitored over a 24wks. period. The P-I study will also evaluate vaccine dose for further investigation in a P-II/III trial
  • ReiThera is expecting the results of interim safety and immunogenicity analysis by mid Q4’20 which will guide dose selection for P-II/III trial. The company plans to commence international P-II/III in countries with high rates of SARS-CoV-2 infection by the end of 2020, post-P-I outcomes

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: Global Times

Chugai’s Kadcyla (trastuzumab emtansine) Receives MHLW’s Approval for Adjuvant Therapy of HER2-Positive Early Breast Cancer

Shots:

  • The approval is based on P-III KATHERINE study assessing Kadcyla (100/160mg, IV) adjuvant therapy in 1486 patients with HER2+ early BC who did not have pathologic complete response following neoadjuvant therapy including Herceptin
  • The results showed the superiority of Kadcyla over Herceptin in terms of the 1EPs of invasive disease-free survival. The safety profile of the therapy in the study was consistent with the previously approved treatment of HER2-positive metastatic BC, and was well-tolerated as an adjuvant treatment in HER2-positive early BC
  • Kadcyla is an ADC and a postoperative new treatment option to improve prognosis in the treatment of HER2-positive early BC when pCR is not obtained by neoadjuvant therapy

Click here ­to­ read full press release/ article | Ref: Chugai | Image: Pune365

Related News: Roche’s Kadcyla (trastuzumab emtansine) Receives Health Canada’s Approval for The Treatment of HER2-Positive Early Breast Cancer After Surgery

AstraZeneca’s Imfinzi (durvalumab) Receives MHLW’s Approval for Extensive-Stage Small Cell Lung Cancer

Shots:

  • The approval is based on P-III CASPIAN study assessing Imfinzi + etoposide and either carboplatin/ cisplatin CT or Imfinzi & CT+ tremelimumab vs CT as monothx. as 1L treatment in 805 patients with ES-SCLC. The trial used an FD of Imfinzi (1,500mg, q3w for 4 cycles) while in combination with CT and then q4w until disease progression
  • Results: the study met its 1EPs of OS in Jun’2019, demonstrated a 27% reduction in risk of death with m-OS (13.0 vs 10.3 mos.); ORR (68% vs 58%). An updated analysis demonstrated sustained efficacy after a median follow up 2+ yrs., m-OS (12.9 vs 10.5 mos.)
  • Imfinzi is a mAb targeting PD-L1 and blocks the interaction of PD-L1 with PD-1 and CD80, countering the tumor’s immune-evading tactics and releasing the inhibition of immune responses

Click here ­to­ read full press release/ article | Ref: AstraZeneca | Image: Clinical Lab Products

Pfizer and BioNTech Plan for Regulatory Review of its COVID-19 Vaccine in October 2020

Shots:

  • The companies have shared additional P-I safety and immunogenicity data from their ongoing US study of the BNT162b2 against SARS-CoV-2, which has advanced into P-II/III evaluation. Across all populations, BNT162b2 was well tolerated with mild to moderate fever in fewer than 20% of the participants
  • In P-I study, BNT162b2 (@7days after the second dose of 30μg) elicited SARS-CoV-2–neutralizing GMTs in younger adults (18-55yrs.) that were 3.8 times the GMT of a panel of 38 sera of SARS-CoV-2 convalescent patients, and in older adults (65-85 years of age), it elicited a neutralizing GMT 1.6 times the GMT of the same panel
  • The companies anticipate commencing the global (Ex- China) P-II/III study of BNT162b2 in up to 30,000 participants that started in Jul’2020, which has to date enrolled 11,000+ patients including in areas with significant SARS-CoV-2 transmission

Click here to­ read full press release/ article | Ref: Pfizer | Image: Smartworld

Related News: Pfizer and BioNTech Elicits Strong T-cell Response in P-I/II Study Against COVID-19

Novartis’ Kesimpta (ofatumumab) Receives the US FDA’s Approval as the First Self-Administered Therapy for Relapsing Multiple Sclerosis

Shots:

  • The approval is based on P-III ASCLEPIOS I & II studies assessing Kesimpta (20mg, monthly, SC) vs teriflunomide (14mg, qd) in 1,882 patients aged 18-55yrs. with RMS with an EDSS b/w 0 and 5.5 across 37 countries. Additionally, P-II APLIOS study determine the bioequivalence of subcutaneous delivery of Kesimpta via a prefilled syringe and a Sensoready pen in patients with RMS
  • ASCLEPIOS I & II studies results: reduction in ARR 51% & 59% (0.11 vs 0.22) & (0.10 vs 0.25), 34% reduction in 3mos CDP, reduction in number of Gd+ T1 (98% & 94%) and new/ enlarging T2 lesions (82% & 85%) respectively
  • In a post hoc analysis, Kesimpta may halt new disease activity in RMS with 47.0% & 7.8% of patients achieved (NEDA-3) within (0–12mos.) and (12–24 mos.) of treatment, respectively. The therapy is expected to be available in the US in early Sept’2020 along with its anticipated EU approval in Q2’21

Click here ­to­ read full press release/ article | Ref: Novartis | Image: KRCU

Evotec and Centogene Expand their Collaboration to Target Gaucher Disease

Shots:

  • The two companies will work together to research, discover, and develop therapeutic options related to the deficiency of the protein GBA which is a gene linked to Gaucher disease
  • The collaboration will combine Evotec’s iPSC platform and drug discovery and development capabilities with Centogene’s global rare disease platform, including iPSC lines
  • The collaboration follows the companies 2018 agreement to discover and develop novel small molecules in rare hereditary metabolic diseases

Click here ­to­ read full press release/ article | Ref: Evotec | Image: Wikipedia

AstraZeneca Collaborates with mAbxience to Produce COVID-19 Vaccine in Latin America

Shots:

  • mAbxience will produce ~200M + doses of AZD1222 and will supply it to all Latin American countries, except Brazil
  • The company will produce API in its facility located in Garín (Argentina) and will send it to Mexico to complete the production and filling process. AstraZeneca will transfer its technology to the Garín plant shortly, allowing the facility to produce the vaccine in the coming months
  • AstraZeneca’s AZD1222 has demonstrated robust immune response in its P-I & II studies, being evaluated in P-III study with its expected completion in the coming months. The vaccine is expected to be available in the H1’21, upon completion of the P-III trial and approval

Click here ­to­ read full press release/ article | Ref: mAbxience | Image: Thailand Medical News

Related News: AstraZeneca to Initiate Production of its COVID-19 Vaccine Early in 2021

Roche’s Enspryng (satralizumab-mwge) Receives the US FDA’s Approval for Neuromyelitis Optica Spectrum Disorder

Shots:

  • The approval is supported by P-III SAkuraStar and SAkuraSky studies involve assessing Enspryng (120mg, SC, q4w) as a monothx. & as an add-on therapy to baseline IST vs PBO in 95 & 83 patients aged 20-70 &  13-73yrs. in a ratio (2:1) & (1:1) administered at week 0,2 & 4 in patients with NMOSD respectively
  • The studies demonstrated robust efficacy and a favorable safety profile in adults with AQP4 Ab positive NMOSD. relapse-free patients @96wks. (76.5% & 91.1% vs 41.1% & 56.8%)
  • Enspryng is the first and only FDA-approved SC treatment option for AQP4 Ab positive NMOSD that can be self-administered by a patient or a caregiver every four weeks. The therapy is mAb targeting IL-6 that utilizes recycling antibody technology and will be available in the US in two wks.

Click here ­to­ read full press release/ article | Ref: Roche | Image: HKU E-Learning Platform

Related Post: Roche’s Enspryng (satralizumab) Receives MHLW’s Approval for Neuromyelitis Optica Spectrum Disorder in Japan

Abeona Signs a License and Inventory Purchase Agreements with Taysha for ABO-202 to Treat CLN1 Disease (Infantile Batten disease)

Shots:

  • Abeona to receive $7M including $3M up front, $4M inventory purchase price, including GMP-sourced CLN1 plasmid and is eligible to receive $56M as clinical, regulatory, and commercial milestones along with royalties on sales of ABO-202
  • Taysha gets an exclusive WW right to IP developed by scientists at the UNC and Abeona and Abeona know-how relating to the research, development, and manufacture of ABO-202. Abeona will continue the development of the P-I/II clinical trial protocol and manufacturing process and has received FDA clearance of its IND application that is anticipated to enter the clinic in 2021
  • ABO-202 is a novel, one-time gene therapy for CLN1 disease, designed to deliver a functional copy of the PPT1 gene and has received the US FDA’s ODD, RPD and EMA’s OMPD

Click here ­to­ read full press release/ article | Ref: Abeona Therapeutics | Image: Pexel

Swittons Introduces Smart IoT Devices for Pharmaceutical Lab Digital Transformation Initiatives

Swittons, a P360 company, has announced a new line of Internet of Things (IoT) enabled smart devices built specifically for pharmaceutical labs. The fully customizable devices align with strategic Lab of the Future(LoTF) initiatives and help automate various laboratory workflows between people and existing digital lab equipment, systems and solutions. Built on an agile technology platform, Swittons devices are easy to deploy within pharmaceutical laboratories of all types.

“There are profound changes taking place in the area of life science research and development,” stated Swittons CEO and Founder Anupam Nandwana. “Driven by technological advances and the development of precision medicines, these modernization initiatives are designed to propel laboratory efficiencies into the future, allowing scientists to spend more time on science. This has changed the very concept of what the lab is, and Swittons is a key part of that evolution.”

The Swittons software platform is designed to provide life sciences companies with a modern, flexible user interface that not only integrates with other systems, but other IoT devices as well. This flexibility gives labs the power to create their own LoTF, configured in the way that works best for their specific use case. This means Swittons devices can be uniquely programmed, even within an individual laboratory, so end users aren’t forced into workflows that don’t fit their job function. In addition, the devices take up very little desk space, so they are conveniently available and work seamlessly within individual work styles.

Swittons devices are designed to be compatible with existing IT systems and integrate with lab support platforms and services such as LIMS, eDOC and ticketing systems. Swittons also features a powerful backend portal and reporting system, where administrators can view user CLICKS in one convenient location. The devices are even able to trigger phone and video calls via a built-in integration with Microsoft Teams.

Each Swittons device can be custom branded, and programmed for a wide range of laboratory scenarios. In pharmaceutical lab settings, Swittons fills the gap between the scientist and the lab by automating functions such as:

  • Trigger equipment maintenance
  • Open equipment service ticket
  • Indicate equipment availability
  • Trigger a video call
  • Notify of temperature control deviation
  • Notify of spill/cleaning needed
  • Equipment occupancy notification
  • Open Tickets in service software such as ServiceNow, Salesforce Service Cloud, Microsoft Dynamics
  • Reorder reagents
  • Re-stock disposable supplies
  • Report OOS or Aberrant result
  • Summon a lab runner
  • Open SOP software
  • Alert in an emergency

Swittons is built on Microsoft Azure, and each device comes out of the box ready and automatically connects through a Wi-Fi or GSM cellular connection. More information about Swittons for LoTF initiatives is available HERE.

Swittons is powered by the technology and expertise developed by P360. Delivering a 360-view through the pharma physician, laboratory and patient ecosystem, P360 designs and deploys capabilities that ensure the highest efficiencies and returns on sales operations, data management, clinical trials, patient centricity and IoT innovation. To learn more about P360, visit P360.com.

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Novavax Collaborates with UK Government to Supply 60M Doses of NVX-CoV2373 to Combat COVID-19

Shots:

  • Novavax will supply ~60M doses of its COVID-19 vaccine to the UK government for P-III study evaluating the efficacy of NVX-CoV2373 in ~9,000 adults aged 18-85yrs. in the UK. The trial is expected to initiate in Q3’20
  • Novavax will expand its collaboration with FUJIFILM Diosynth, which will manufacture the antigen component of NVX-CoV2373 from its Billingham, Stockton-on-Tees site in the UK, in addition to its sites in NC and Texas in the US
  • The FUJIFILM Diosynth site in the UK is expected to produce up to 180M doses annually, which boosts the global supply of NVX-CoV2373 for additional markets. NVX‑CoV2373 elicited robust Ab responses superior to seen in human convalescent sera in P-I/II clinical study while P-II study is expected to begin in Aug’2020

Click here to­ read full press release/ article | Ref: Novavax | Image: Reuters

SK bioscience Collaborate with Novavax to Supply Antigen for COVID-19 Vaccine

Shots:

  • SK bioscience signs a development and supply agreement for Novavax’ NVX-CoV2373 to supply it globally including the COVAX facility. SK bioscience will manufacture the vaccine antigen component for use in the final drug product
  • SK bioscience will utilize its cell culture and recombinant protein capability, will initiate the production of the NVX-CoV2373 antigen at its facility in Andong L-house, South Korea, expected to begin in Aug’2020
  • Additionally, the companies have signed a letter of intent with the Republic of Korea’s Ministry of Health and Welfare for equitable access to NVX-CoV2373 in global market and to make it available in South Korea

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: Novavax

EC Concludes Exploratory Talks with J&J to Supply 200M Doses of COVID-19 Vaccine

Shots:

  • The EC has the contractual framework in place to purchase the initial 200M doses on behalf of all EU Member States once the vaccine has proven safe and effective. The agreement includes an option to purchase up to an additional 200M dose
  • If approved, the EC expects to facilitate a process for the allocation of the vaccine doses among the member states.
  • The exploratory talks concluded today are intended to result in an Advance Purchase Agreement to be financed with the Emergency Support Instrument, which has funds for vaccines with different profiles and produced by different companies

Click here to­ read full press release/ article | Ref: European Commission | Image: USA Today

AstraZeneca to Initiate Production of its COVID-19 Vaccine Early in 2021

Shots:

  • AstraZeneca collaborates with the Mexican and Argentinean governments to initially produce 150M doses of the vaccine and eventually make at least 400M for distribution throughout the region
  • The price for the vaccine is not final but it is expected not to exceed $4/ dose. The vaccine will initially supply to all Latin American countries except Brazil
  • The clinical trial conducted in the US, South Africa, England, and Brazil is expected to be completed in Nov or Dec’2020, after which the company would seek approvals. If approved, AstraZeneca will transfer technology to Argentina’s INSUD Group and Mexico’s Laboratorios Liomont at the end of the year and begin manufacturing in Q1’21

Click here ­to­ read full press release/ article | Ref: Reuters | Image: Bloomberg

Related News: AstraZeneca Signs an Agreement with Emergent BioSolutions to Expand Manufacturing of AZD1222 for COVID-19

Novo Nordisk Resumes P-III Study of Concizumab for Patients with Hemophilia A and B

Shots:

  • The company resumes the P-III program (explorer6, 7, and 8) of concizumab. The clinical trials are evaluating concizumab (SC) prophylaxis treatment in hemophilia A and B patients regardless of their inhibitor status
  • The trials will be resumed as soon as local procedures allow. This follows pausing of the trials in Mar’20 due to the occurrence of non-fatal thrombotic events in 3 patients enrolled in the ongoing P-III program
  • In Oct 2019, Novo Nordisk has initiated the explorer7 study to establish the safety and efficacy of concizumab (SC, qd) delivered in a pen device to reduce the number of bleeds in patients with hemophilia A or B with inhibitors towards FVIII/ FIX. In Nov 2019, the company initiated P-III explorer8 study in hemophilia A or B patients without inhibitors. The trials are to enroll ~293 patients across 32 countries

Click here ­to­ read full press release/ article | Ref: Novo Nordisk  | Image: Scrip Informa

Roche Reports the US FDA’s Acceptance of sBLA for Xolair (omalizumab) Prefilled Syringe for Self-Administration Across All Indications

Shots:

  • The US FDA has accepted the sBLA for a new self-administration option for Xolair across all approved indications in the US. The company anticipates the approval of the therapy in Q1’21
  • The acceptance is based on the efficacy and safety profile of Xolair in allergic asthma and chronic idiopathic urticaria (CIA)
  • If approved, Xolair’s prefilled syringe will become available for either self-administration by select patients or administration by their caregivers.  Genentech and Novartis work together to develop and co-promote Xolair in the US

Click here ­to­ read full press release/ article | Ref: Roche | Image: Pinterest

Roche Collaborates with Celleron Therapeutics for Emactuzumab to Treat Patients with Tenosynovial Giant Cell Tumor

Shots:

  • Celleron will receive an exclusive global right for the clinical development, manufacturing, and commercialization of emactuzumab (formerly RG7155 and RO5509554). The companies expect the closing of an agreement by the end of 2020
  • 86% of TGCT patients treated with emactuzumab responded to the drug, with 68% of people experiencing a PR within 6 weeks of starting the treatment. The license agreement demonstrated Celleron’s dedication to the development of cancer medicine and its transformational potential for patients inflicted with cancer
  • Emactuzumab (RG7155) is an IgG1 mAb, designed to target and deplete macrophages in the tumor tissue.  The therapy targets TAMs by binding to CSF-1R on the cell surface and blocking its activation by CSF-1

Click here ­to­ read full press release/ article | Ref: Celleron Therapeutics | Image: PharmaShots

Innovent and Eli Lilly Report sNDA Acceptance of Tyvyt (sintilimab) Combination Regimen as 1L Therapy in Squamous Non-Small Cell Lung Cancer in China

Shots:

  • The NMPA has accepted the sNDA for Tyvyt (sintilimab) in combination with Gemzar (gemcitabine) and platinum as 1L therapy in sq. NSCLC
  • The sNDA is based on P-III ORIENT-12 study assessing sintilimab (200mg) vs PBO in combination with Gemzar and Pt (q3w for up to 4 or 6 cycles), followed by either sintilimab or PBO maintenance therapy in 327 patients in a ratio (1:1). The study demonstrated improvement in PFS with no new safety signals
  • Additionally, the therapy in combination with CT has met its 1EPs in ORIENT-11 study in 1L non-squamous NSCLC patients. Today’s acceptance marks the second sNDA of Tyvyt for 1L NSCLC indication

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: PharmaShots

Sarepta Therapeutics Collaborates with University of Florida to Accelerate the Development of Therapies for Rare Genetic Diseases

Shots:

  • Sarepta to fund four research programs at the UF and will get an exclusive option to develop any new therapeutic compounds resulting from the funded research programs.
  • The projects include exploratory research in novel gene therapy vectors, next-generation capsids, and gene editing technologies along with new therapeutic areas in degenerative genetic diseases
  • The focus of the collaboration is to foster early relationships with experts and accelerate the scientific advancements leading to the development of transformational precision genetic medicines targeting the unmet medical needs of patients

Click here ­to­ read full press release/ article | Ref: Sarepta Therapeutics | Image: CNBC

AstraZeneca Collaborates with Daiichi Sankyo to Evaluate the Combination of Patritumab Deruxtecan (U3-1402) + Tagrisso for EGFR-Mutated Non-Small Cell Lung Cancer

Shots:

  • Daiichi Sankyo to conduct two-part P-I study assessing U3-1402+ Tagrisso as both a 1L and 2L dual regimen in patients with advanced or mNSCLC with an EGFR exon 19 deletion or L858R mutation
  • The dose-escalation part will assess the safety & tolerability of different dosing combinations of dual regimen to determine the recommended dose while the second part of the study (dose expansion) will include a 1L and 2L cohort to further evaluate the anti-tumor activity and safety of the regimen
  • In the 1L cohort, patients will receive dual regimens and patients in the 2L cohort will be randomized in a ratio (1:1) to receive treatment with U3-1402 as monothx. or in combination with Tagrisso. 258 patients will be enrolled in the study, which will be conducted in NA, EU, and Asia including Japan

Click here to­ read full press release/ article | Ref: Daiichi Sankyo  | Image: StraitTimes




Roche’s Tecentriq (atezolizumab) + Paclitaxel Fail to Meet the Primary Endpoint in P-III IMpassion131 Study for Patients with Metastatic Triple-Negative Breast Cancer

Shots:

  • The P-III IMpassion131 study involves assessing of Tecentriq + paclitaxel vs PBO + paclitaxel, in 651 people in a ratio (2:1) with previously untreated, inoperable, LA/ m-TNBC
  • The study did not meet its 1EPs of PFS for 1L treatment of people with m-TNBC) in the PD-L1+ population.  The data for 2EPs of OS showed a negative trend, however, the study was not powered for the 2EPs of OS and data were immature at the time of analysis while OS follow-up is planned to continue until the final analysis
  • In the previous IMpassion130 study, Tecentriq + Abraxane demonstrated PFS benefit and, while not formally tested, showed improvements in OS for people with metastatic TNBC whose tumors express PD-L1

Click here ­to­ read full press release/ article | Ref: Roche | Image: Forbes

Related News: Roche’s Tecentriq (atezolizumab) + Abraxane Receive European Commission’s Approval for Patients with PD-L1-Positive Metastatic Triple-Negative Breast Cancer




Moderna Prices its COVID-19 Vaccine at $32-$37 per Dose for Smaller Volume Agreements

Shots:

  • For smaller volume agreements, the company has priced its COVID-19 vaccine ranging from $32-$37/ dose, higher than the price of Pfizer’s vaccine candidate
  • The company is in talks with several countries for supply agreements of its vaccine, adding that it had already received about $400M for supply. The P-III study of mRNA-1273 is being conducted in collaboration with NIH and BARDA with an anticipated completion of enrollment in Sept’2020
  • Moderna has received $1B from the US government under a plan to ramp up vaccine development. The company’s vaccine candidate is one of the few that have already advanced to the final stage of testing

Click here ­to­ read full press release/ article | Ref: Reuters | Image: PharmaShots




Novartis Reports Results of Ofatumumab (OMB157) in P-III ASCLEPIOS Trials for Relapsing Multiple Sclerosis

Shots:

  • The two P-III studies, ASCLEPIOS I & II involves assessing of ofatumumab (20mg, monthly SC) vs teriflunomide (14mg) in 1882 patients aged 18-55yrs with MS and EDDS score b/w 0 and 5.5.  The studies were conducted across 37 countries in 350+ sites 
  • Results of ASCLEPIOS I & II: 51% & 58% reduction in ARR (0.11 vs 0.22 & 0.10 vs 0.25); reduction Gd+T1 lesions (97% & 94%); reduction in new or enlarging T2 lesions (82% & 85%); superior in reducing neuroaxonal damage in both studies, as measured by NfL serum concentrations; 34% and 32% risk reduction in 3mos. and 6mos. CDW; favorable trend in rate of 6mos. CDI; no difference in annual rate of brain volume loss
  • Ofatumumab (SC, once monthly) is a CD20 mAb, targeting CD20 molecule on the B-cell surface and inducing potent B-cell lysis and depletion with its anticipated US FDA’s approval in Sept’20 and in EU by Q2’21

Click here ­to­ read full press release/ article | Ref: Novartis | Image: Clinical Trial Arena

Related News: The US FDA Extends Review of sBLA of Ofatumumab (OMB157) for Patients with Relapsing Multiple Sclerosis




Johnson & Johnson Signs an Agreement with the US Government to Supply 100M Doses of COVID-19 Vaccine Worth ~$1B

Shots:

  • The US government will pay over $1B for 100M doses of its potential COVID-19 vaccine, Ad26.COV2.S, for use in the US following the US FDA’s EUA
  • The government may also purchase additional 200M doses of Ad26.COV2.S under a subsequent agreement. The company is evaluating one- and two-dose regimens, in its clinical program for the global access of the vaccines
  • J&J expects to meet its goal to supply 1B doses globally through the course of 2021, provided the vaccine is safe and effective. The vaccine will be provided at a global not-for-profit basis for emergency pandemic use

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: PharmaShots

Related News: Johnson & Johnson Initiates P-I/IIa Study of its Ad26.COV2.S Against COVID-19 in the US and Belgium




BioNTech and Fosun Pharma Initiate Clinical Trial of BNT162b1 Against COVID-19 in China

Shots:

  • The P-I study will evaluate the safety and immunogenicity of the vaccine as well as confirm dose selection in ~144 healthy subjects aged 18-55 and >55 yrs. As part of the two-dose cohort design, subjects will receive two injections (prime-boost), 21 days apart  BNT162b1 vs PBO
  • The dose range was determined based on early data from clinical trials conducted in Germany and the US. The participants will be dosed in Taizhou clinical P-I center, Jiangsu province
  • BioNTech will provide the clinical supply of the vaccine from its GMP-certified mRNA manufacturing facilities in EU while Fosun Pharma will exclusively commercialize the vaccine in Mainland China, Hong Kong, and Macau Special Administration Regions and in Taiwan if received approval in China

Click here ­to­ read full press release/ article | Ref: GlobeNewswire | Image: PharmaShots

Related News: Fosun Pharma Signs an Agreement with BioNTech to Develop and Commercialize BNT162 for COVID-19




AbbVie Terminates Tau and ASN Agreement with Voyager Signed in 2018 and 2019

Shots:

  • Voyager retains full rights to the vectorization technology and novel vectorized Abs emerges from the collaboration and has the right to pursue vectorized Ab programs targeting tau and alpha-synuclein alone or in collaboration with another partner
  • As per collaboration agreements, Voyager has received an upfront payment to perform research and preclinical development of vectorized Abs directed against tau and alpha-synuclein in AD & PD respectively
  • Voyager is not obligated to repay the upfront payment it received from AbbVie in connection with the Tau & ASN agreement but is no longer eligible to receive option payments, milestone payments, or royalties thereunder

Click here, Click here ­to­ read full press release/ article | Ref: Voyager | Image: PharmaShots




Janssen’s Darzalex (daratumumab, SC) Receives Health Canada Approval for the Treatment of Patients with Multiple Myeloma

Shots:

  • The Health Canada has approved Darzalex SC (daratumumab) in four regimens across five indications in patients with MM, notably newly diagnosed, transplant-ineligible patients as well as relapsed/refractory patients
  • The approval is based on P-III COLUMBA and P-II PLEIADES studies. The P-III study demonstrated a consistent ORR (41% vs 37%), with PK & safety profile compared with Darzalex IV in patients with RRMS, 2/3rd reduction in systemic ARRs (13% vs 34%)
  • In P-II PLEIADES study evaluates Darzalex SC + D-VMP in newly diagnosed transplant-ineligible patients & Darzalex SC + (D-Rd) in R/R patients prior treated with 1L therapy. In general, Darzalex SC reduces administration time from hours to minutes and demonstrates consistent efficacy with a reduction in administration-related reactions

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: Explore




Eli Lilly in Collaboration with NIAID Initiate P-III Study of LY-CoV555 to Prevent COVID-19

Shots:

  • Eli Lilly initiates P-III BLAZE-2 study assessing LY-CoV555 to prevent SARS-CoV-2 infection and COVID-19 in residents and staff at long-term care facilities in the US (skilled nursing facilities, commonly referred to as nursing homes, and assisted living facilities)
  • The company will enroll up to ~2400 patients and test whether a single dose of LY-CoV555 reduces the rate of SARS-CoV-2 infection @4wks. as well as complications of COVID-19 @8wks.
  • LY-CoV555 is a potent, neutralizing IgG1 mAb, directed against the spike protein of SARS-CoV-2. The therapy emerges from the collaboration b/w Lilly and AbCellera to create Ab therapies for the prevention & treatment of COVID-19

Click here ­to­ read full press release/ article | Ref: Eli Lilly | Image: Fierce Pharma




Sanofi and GSK Receive $2.1B from the US Government to Supply 100M Doses of COVID-19 Vaccine

Shots:

  • The US government will provide ~$2.1B to support the development of the vaccine, including clinical trials with some amount to be used for ramping up the manufacturing and delivery of an initial 100M dose of the vaccine
  • The US government has an option to supply an additional 500M dose and helps the government’s Operation Warp Speed goals for providing millions of doses of a safe and effective COVID-19 vaccine
  • Additionally, the companies are in discussion with the EC for the supply of up to 300M doses of a COVID-19 vaccine. Both the companies are committed to making their COVID-19 vaccine affordable and available globally

Click here, Click here ­to­ read full press release/ article | Ref: GSK, GSK | Image: WorldPharma Today

Related News: Sanofi and GSK Sign an Agreement with the UK Government to Supply ~60M Doses of COVID-19 Vaccine




Johnson & Johnson Initiates P-I/IIa Study of its Ad26.COV2.S Against COVID-19 in the US and Belgium

Shots:

  • J&J’s Ad26 vector-based vaccine demonstrated robust immune response in the pre-clinical study by neutralizing Abs, preventing infection and provide complete/ near-complete protection in the lungs from the virus in NHPs
  • Based on the preclinical studies, the company has commenced the P-I/IIa study of Ad26.COV2.S, in healthy volunteers in the US and Belgium with expected initiation of P-III study in Sept’2020. The P-I/IIa study will evaluate the safety, reactogenicity, and immunogenicity of Ad26.COV2.S in ~1,000 healthy adults aged 18-55yrs. and 65+ yrs.
  • Additionally, the company is planning to initiate P-III clinical trial program, will evaluate both one/two-dose regimens of Ad26.COV2.S initiate in parallel studies while the P-IIa study in the Netherlands, Spain, and Germany and a P-I study in Japan in underway

Click here ­to­ read full press release/ article | Ref: Johnson & Johnson | Image: StraitTimes




Roche’s Tecentriq + Cotellic and Zelboraf Receives the US FDA’s Approval for Patients with Advanced Melanoma

Shots:

  • The approval is based on P-III IMspire150 study assessing Tecentriq (atezolizumab) + Cotellic  (cobimetinib) + Zelboraf (vemurafenib) vs  PBO + Cotellic +   Zelboraf in patients with BRAF V600 mutation-positive advanced melanoma
  • Results: mPFS (15.1 vs 10.6mos.); the safety profile of the Tecentriq combination was consistent with the known safety profiles of the individual medicines. The review was conducted under Project Orbis
  • Tecentriq is a mAb targeting PD-L1, acts by blocking is its interactions with both PD-1 and B7.1 receptor. Cotellic is a MEK1/2 inhibitor in a cell signaling pathway that helps control cell growth and survival while Zelboraf is a prescription medicine for melanoma that has spread to other parts of the body or cannot be removed by surgery and has a BRAF V600 mutation

Click here ­to­ read full press release/ article | Ref: Roche | Image: StraitTimes




UCB Canada’s Brivlera (brivaracetam) Receives Health Canada Approval to Treat Partial-Onset Seizures in Pediatric Epilepsy Patients

Shots:

  • The approval is based on the principle of extrapolation of its efficacy data in adults also supported by pharmacokinetic and safety data in children. Additionally, the safety and tolerability data of Brivlera in children 4 years and older were similar to observed in adults
  • The usage of Brivlera in pediatric and adolescent patients is supported by the placebo-controlled partial-onset seizure studies in adults, PK study in pediatric aged 4 to 17 years of and for the achievement of similar plasma concentrations as of adults weight-based dose adaptations were practiced
  • Brivlera is an anti-epileptic drug (AED) displays a high and selective affinity for synaptic vesicle protein 2A (SV2A) developing anticonvulsant effects, approved by Health Canada as adjunctive therapy for partial-onset seizures in patients 4 years of age and older

Click here to read full press release/ article | Ref: Newswire | Image: Twitter




BARDA Signs a Multi-Year Agreement with Regeneron for its REGN-EB3 for National Preparedness

Shots:

  • Regeneron will be responsible to deliver treatment doses for six years post-approval of product from the FDA, will receive compensation of ~$10M & average of $67M/year in 2021 and each for the next five years (2022-2026) respectively
  • In 2019, the PALM trial evaluated REGN-EB3 vs ZMapp conducted in the Democratic Republic of the Congo, was stopped as the REGN-EB3 crossed the pre-specified superiority threshold for preventing death in Ebola patients
  • Regeneron’s REGN-EB3 is a novel anti-viral Ab cocktail developed using its VelociSuite platform in collaboration and funding provided by BARDA. The product is under priority review by the US FDA with PDUFA date Oct 25, 2020

Click here to read full press release/ article | Ref: BusinessWire | Image: Behnace




Roche’s Actemra/RoActemra (tocilizumab) Fails to Meet the Primary Endpoint in P-III COVACTA Study for Patients with COVID-19 Associated Pneumonia

Shots:

  • The P-III COVACTA study involves assessing of Actemra/RoActemra (IV) + SOC vs PBO + SOC in adult patients hospitalized with severe COVID-19 associated pneumonia. Patients will be followed for 60 days post-randomization
  • The study did not meet its 1EPs i.e. improvement in clinical status and 2EPs i.e. difference in patient mortality @4wks. (19.7% vs 19.4%); median time to discharge (20 vs 28days); rate of infection (38.3% vs 40.6%); rates of serious infections (21.0% vs 25.9%)
  • Actemra/RoActemra was the first approved anti-IL-6 receptor biologic available in both IV/ SC formulations for the treatment of adult patients with moderate-to-severe active RA. Roche will continue the clinical study of Actemra in other treatment settings including in combination with an antiviral

Click here ­to­ read full press release/ article | Ref: Roche | Image: StraitTimes




Sanofi and GSK Sign an Agreement with the UK Government to Supply ~60M Doses of COVID-19 Vaccine

Shots:

  • The two global companies will supply up to ~60M doses of a vaccine to the UK’s government to combat COVID-19
  • Sanofi leads the clinical development and registration of the vaccine and expects a P-I/II study to be initiated in Sept’2020, followed by a P-III study by the end of 2020. Additionally, the companies are expecting the approval in H1’21
  • The vaccine is deploying Sanofi’s S-protein COVID-19 antigen together with GSK’s adjuvant technology. Both the companies are scaling up manufacturing of the antigen and adjuvant to produce up to 1B doses per year

Click here ­to­ read full press release/ article | Ref: Sanofi | Image: PharmaShots

Related News: Sanofi and GSK Collaborate to Develop Adjuvanted COVID-19 Vaccine




Roche and UCB Collaborate to Develop UCB0107 for Alzheimer’s Disease

Shots:

  • UCB to receive $120M and is eligible to receive $2B as cost reimbursement, development, and commercial milestones as well as royalties on sales of the therapies, if Roche proceeds the clinical development. Roche to get an exclusive license to develop and commercialize UCB0107 for AD
  • UCB to fund and perform a POC study in AD and, upon the availability of the results of that study while Roche has the right to progress with the development or return full rights back to UCB
  • UCB0107 is an IgG4 mAb targeting a central Tau epitope, being developed to block/reduce the spread of Tau pathology. UCB continues to develop UCB0107 in PSP, with anticipated initiation of P-III study in Q2’21

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: PharmaShots




Ciox Health Acquires Biomedical NLP Company Medal

Ciox Health Acquires Biomedical NLP Company Medal

What You Should Know:

– Ciox Health has acquired Medal, Inc., a biomedical
Natural Language Processing (biomed-NLP) technology company.

– The acquisition will lead Ciox to better and more
quickly enable real-world data in support of research that advances patient
care.


Ciox
Health
, a leading health technology company, today announced its acquisition
of San Francisco-based biomedical Natural Language Processing (biomed-NLP)
technology company, Medal, Inc., a leader
in the application of AI techniques to the interrogation of unstructured
medical record data. The acquisition accelerates capabilities to enable
real-world data (RWD) in support of research that advances patient care.

The Real-World Data Advantage

As more pharmaceutical and research organizations look to real-world data to accelerate clinical research, reliable identification, and interpretation of phenotypic data from deep inside medical records are becoming paramount. The most relevant information resides in the unstructured data: the surgical reports, pathology reports, imaging reports, discharge summaries, and other clinician-scribed narrative text. Medal’s software helps identify, contextualize, and interpret narrative-based medical notes, leading to the creation of research-grade data sets at scale. The company’s approach to biomed-NLP and deep learning AI is guided and informed by consensus from clinical expert reviewers across therapeutic areas.

“More than 100 million medical records are retrieved and reviewed by Ciox each year from the vast majority of U.S. providers, presenting an unprecedented opportunity to actually bring a true longitudinal perspective to clinical investigation. Ciox works at the first and last mile of U.S. healthcare data,” says Andy McMurry, Ph.D., Chief Science Officer of Medal. “Using Medal AI, Ciox will reduce human expert time and increase the utility of patient data to support biomedical discovery and clinical trials research across many disease areas, including COVID-19. Combining vast biomedical knowledge sources with clinically trained Artificial Intelligence enabling human experts, we are reinventing real-world data for clinical investigation.”

Acquisition Benefits for Ciox Health

This acquisition is the third major recent announcement from
Ciox’s growing Real World Data business, following two prior announcements of
strategic collaborations with LabCorp and Merck. As health data remains
fragmented throughout the U.S. healthcare ecosystem, Ciox is attracting
interest in its RWD division from medical research organizations and other
partners. This additional feature of the Ciox DataFit Platform through the
acquisition of Medal will enable faster and more consistent translational
research. 

Why It Matters

“We’re proud to bolster the Ciox Real World Data offering with Medal’s technology and team,” says Pete McCabe, CEO, Ciox. “The team and the biomed-NLP product, combined with Ciox’s technology-enabled ability to create longitudinal records across EHRs and provider systems, remove the friction related to medical records-based clinical research.  We will consistently supply consented, HIPAA-compliant, de-identified, research-grade RWD for complex clinical use cases to commercial researchers in pharma and biotech, as well as government sponsored researchers. The need is particularly highlighted in the COVID-19 research questions being asked by agencies like the FDA, CDC and NIH.”

AstraZeneca Signs an Agreement with Emergent BioSolutions to Expand Manufacturing of AZD1222 for COVID-19

Shots:

  • Emergent will provide CDMO services for AstraZeneca’ AZD1222. The agreement valued ~174M through 2021 and follows an $87M agreement signed in June for development services, performance and process qualification, raw materials, and an initial capacity reservation
  • The two companies may enter additional commercial manufacturing agreement as the candidate progresses over three years through Emergent’s flexible capacity deployment model. The agreement follows CDMO partnership b/w Emergent and the BARDA signed in June to pave the way for OWS high-priority innovators
  • The University of Oxford and its spin-out company, Vaccitech co-invented AZD1222 and was licensed to AstraZeneca. The vaccine is under clinical trial for COVID-19

Click here ­to­ read full press release/ article | Ref: Emergent | Image: PharmaShots




Pfizer and BioNTech Initiate P-II/III Global Study of its Lead mRNA Vaccine Candidate Against COVID-19

Shots:

  • The companies commence global (Ex- China) P-II/III study to evaluate a modRNA candidate (BNT162b2, 30µg dose level in a 2 dose regimen) from their BNT162 mRNA-based vaccine program against SARS-CoV-2
  • The P-II/III study follows the US FDA’s guidance on clinical trial design, will evaluate up to 30,000 participants in a ratio (1:1)  aged 18 – 85yrs. started in the US and is expected to include ~120 sites globally 
  • Assuming clinical success, companies expect to seek regulatory approval as early as Oct’2020. Following the approval, the companies currently aim to supply globally up to 100M doses by the end of 2020 and ~1.3B doses by the end of 2021. BNT162b2 encodes an optimized SARS-CoV-2 full-length spike glycoprotein (S), which is the target of virus-neutralizing Abs and has received the US BT designation

Click here ­to­ read full press release/ article | Ref: Pfizer | Image: StraitTimes

Related News: Pfizer and BioNTech Elicits Strong T-cell Response in P-I/II Study Against COVID-19




Kite’s Tecartus (brexucabtagene autoleucel) Receives the US FDA’s Approval as the First Cell-Based Gene Therapy for Relapsed or Refractory MCL

Shots:

  • The accelerated approval follows FDA’s PR and BT designation and is based on ZUMA-2 study assessing Tecartus (formerly KTE-X19) in 74 patients with r/r MCL prior treated with  anthracycline/ bendamustine-containing CT, an anti-CD20 Ab therapy and a BTK inhibitor (ibrutinib or acalabrutinib)
  • Results: 87% patients responded to Tecartus (single infusion), including 62 % patients achieved CR, 18% experienced Grade 3 or higher CRS and 37% experienced Grade 3 or higher neurologic toxicities
  • Tecartus is an autologous, anti-CD19 CAR T cell therapy, currently under EC review and has received EMA’s PRIME designation for r/r MCL. The therapy will be manufactured in Kite’s commercial manufacturing facility in El Segundo, California

Click here to read full press release/ article | Ref: Kite | Image:  Stat News




AstraZeneca Signs an Agreement with Daichii Sankyo to Develop and Commercialize DS-1062 Worth Up to $6B

Shots:

  • Daichii Sankyo to receive $1B as upfront of which $350M is due upon execution, $325M after 12mos. and $325M after 24 mos., ~$5B as contingent payment including $1B as regulatory milestones, and $4B as commercial milestones, making a total deal value up to ~6B
  • The companies will jointly develop and commercialize DS-1062 globally and share equal development & commercialization costs, except in Japan where Daiichi Sankyo will maintain exclusive rights and manufacture and supply DS-1062
  • Daiichi Sankyo is expected to book sales in the US, certain EU countries, and other markets where the company has affiliates while AstraZeneca is expected to book sales in other markets globally, including China, Australia, Canada, and Russia. DS-1062 is a TROP2 directed DXd ADC, currently in P-I study for NSCLC and TNBC

Click here ­to­ read full press release/ article | Ref: Daichii Sankyo | Image: Pahrmashots

Related News: Daiichi Sankyo in Talks with AstraZeneca for the Supply of AZD1222 to Combat COVID-19 in Japan




Synaffix Expands its Existing Collaboration with ADC Therapeutics to Explore Two Additional Programs

Shots:

  • Synaffix to receive upfront, milestone and royalty payments tied to each program while ADC gets a non-exclusive right for two additional programs, bringing the total number of programs to five
  • ADC also get access to Synaffix’ GlycoConnect platform, including DAR1 technology enabling stable attachment of just a single drug per antibody
  • In 2016, the two companies collaborated, under which ADC Therapeutics is responsible for the research, development, manufacturing, and commercialization of any resulting ADC products while Synaffix is responsible for the manufacturing of components specifically related to its ADC technologies

Click here to read full press release/ article | Ref: Businesswire | Image: Synaffix




Genentech Reports Results of Port Delivery System with Ranibizumab in P-III Archway Study for Neovascular Age-Related Macular Degeneration

Shots:

  • The P-III Archway study involves assessing of PDS with ranibizumab, refilled @6mos. at fixed intervals, vs ranibizumab (0.5mg, monthly IVT) in 418 patients with nAMD, prior treated with VEGF therapy
  • Results: 98.4% of PDS patients were able to go 6mos. without needing additional treatment and achieved vision outcomes equivalent to patients receiving ranibizumab (0.5mg, monthly IVT), PDS demonstrated non-inferior and equivalent visual acuity outcomes with a favorable benefit-risk profile
  • PDS is a permanent refillable eye implant that continuously delivers a customized formulation of ranibizumab over a period of mos., potentially reducing the treatment burden associated with frequent eye injections

Click here to read full press release/ article | Ref: Genentech | Image: Twitter




Daiichi Sankyo Signs a Research Agreement Gustave Roussy for DS-1062 and Patritumab Deruxtecan to Treat Lung and Breast Cancer

Shots:

  • Gustave Roussy to receive funding and support from Daiichi Sankyo for integrative research program including clinical, translational, and preclinical studies for DS-1062 and patritumab deruxtecan in lung and breast cancer respectively
  • The research program includes two P-II studies evaluating the efficacy, safety, and markers of response and resistance to DS-1062 & patritumab deruxtecan in patients with advanced NSCLC, progressed on anti-PD-1/PD-L1 therapy and Pt-doublet CT & HER3 expressing mBC respectively
  • Each study will enroll ~100 patients and will be conducted at several sites in France. The 1EPs of the studies will be ORR and 2EPs includes clinical benefit rate, PFS, DoR, OS, and safety measures. DS-1062 is a TROP2 directed DXd ADC while patritumab deruxtecan is a HER3 directed DXd ADC

Click here to read full press release/ article | Ref: Daiichi Sankyo| Image: ETHealthworld




Evotec Collaborates with Quantro Therapeutics to Discover and Develop Novel Therapies for Cancer and Other Diseases

Shots:

  • The two companies collaborated to discover and develop novel therapeutics interfering with the disease-causing transcriptional programs in cancer and other diseases. Quantro intends to revamp the scope of pharmacologic interventions in a variety of cellular, target and disease contexts
  • Quantro will exploit its functional-genetic and transcriptomic technologies addressing the undruggable targets while Evotec will provide its hit identification services for Quantro’s anti-tumor projects
  • Additionally, Evotec joins Boehringer Ingelheim Venture Fund as seed investor in Quantro and acquired equal minority stakes in Quantro

Click here to read full press release/ article | Ref: Evotec | Image: Evotec




Roche Collaborates with Jnana Therapeutics to Discover Novel Therapies to Treat Immune-Mediated and Neurological Diseases

Shots:

  • Jnana to receive $40M upfront payment in cash and is eligible to get ~$1B as research funding, preclinical, development, and commercialization milestone along with royalties on sales of the therapies
  • The partners will work on the discovery and preclinical development of therapies targeting key regulators of cellular metabolism to treat across immunology and neuroscience while Roche will further develop and commercialize the therapies exclusively
  • The collaboration leverages Jnana’s RAPID platform designed to overcome the challenges of directly targeting SLC transporters. The RAPID platform is a cell-based platform that can be used to screen small molecule libraries to identify novel modulators of SLC transporter

Click here to read full press release/ article | Ref: Businesswire | Image: Twitter




Pfizer and BioNTech Elicits Strong T-cell Response in P-I/II Study Against COVID-19

Shots:

  • The companies reported that most advanced of four COVID-19 vaccine candidates from their BNT162 mRNA-based vaccine program demonstrated the ability to elicit high SARS-CoV-2 neutralizing titers following the second dose in an ongoing P-I/II study in Germany
  • The results divulge that BNT162b1 candidate induced strong CD4+ and CD8+ T-cell responses. BNT162b1 elicits RBD-specific, interferon-g+, IL-2+, CD8+ T cells in immunized participants indicating a strong potential for cell-mediated anti-viral activity
  • BNT162b1 induced broad neutralizing activity in pseudovirus neutralization assays across a panel of 16 SARS-CoV-2 RBD variants, including D614G strain. Data from German and US P-I/II studies will be used by the two companies to determine a dose level and select among multiple vaccine candidates to seek to progress in global P-IIb/III safety and efficacy trial, expected to begin in Jul’20 end

Click here to read full press release/ article | Ref: Businesswire | Image: Barron

Related News: Pfizer and BioNTech Report Results of BNT162b1 mRNA-Based Vaccine in P-I/II Study Against COVID-19




AstraZeneca and Oxford University’s AZD1222 Delivers Dual Immune Response in its P-II/III COV001 Study Against COVID-19

Shots:

  • The P-II/III COV001 designed to determine the safety, immunogenicity, and efficacy of the AZD1222 (single dose or two doses of AZD1222 at 5×1010 viral particles) vs single dose of meningococcal conjugate vaccine (MenACWY) as control vaccine in up to 1,077 healthy adults aged 18-55yrs. in 5 trial centers in the UK
  • The study demonstrated that a single dose of the AZD1222 resulted in 4 times increase in Abs to the SARS-CoV-2 virus spike protein in 95% of participants one month after injection. A T-cell response was induced in all the participants, which was maintained two months after vaccination, as per the interim results. The peak response was noted by day 14
  • 91% of participants showed neutralizing Abs against SARS-CoV-2 following a single dose of AZD1222 and 100% following a second dose. The levels of neutralizing Abs seen in participants receiving either one/ two doses were in a similar range to those seen in convalescent COVID-19 patients

Click here to read full press release/ article | Ref: AstraZeneca | Image: Bloomberg

Related News: Daiichi Sankyo in Talks with AstraZeneca for the Supply of AZD1222 to Combat COVID-19 in Japan




Celltrion Initiates P-I Study of its COVID-19 Antibody Treatment in South Korea

Shots:

  • The P-I study follows positive pre-clinical results and the Korean MFDS’ IND approval. The study will enroll ~32 healthy volunteers in collaboration with Chungnam National University Hospital to assess the safety of the antiviral Ab treatment candidate in patients who have not been diagnosed with COVID-19
  • The trial is expected to be completed in Q3’2020. The company plans to conduct a P-I trial of the therapy in mild COVID-19 patients across the EU, including the UK, followed by global P-II/III trials in patients with mild/moderate COVID-19. Celltrion expects preliminary results from pivotal studies by late 2020
  • Additionally, the company will evaluate the treatment for use as a preventative measure and enroll people in close contact with COVID-19 patients globally with its anticipated results in Q1’21. Celltrion’s Ab treatment candidate has demonstrated effectiveness in neutralizing the mutated G-variant strain of SARS-CoV-2 (D614G variant)

Click here ­to­ read full press release/ article | Ref: Businesswire | Image: GMP News




Alnylam’s Anant Murthy on making it as a US biotech in Europe

Alnylam’s European head of market access and GM of mid-size markets, Anant Murthy, shares his perspective on how a US biotech can adapt to the many unique challenges of the EU market.

Though they represent the two biggest markets for pharma companies, the EU and US have some stark differences that can often catch out biotech leaders looking to expand from America into Europe.

Anant Murthy is one leader well-placed to know what it takes to succeed in the region. Originally from the US, he has spent much of his career in Europe, and now heads up market access and several EU countries for mid-sized Alnylam Pharmaceuticals, based in Switzerland, which specialises in RNA interference (RNAi) therapeutics.

He says that the biggest challenge people often face in bringing a US biotech to Europe is in accepting that some European markets will have no problem denying access to specific medicines.

“That’s really uncommon in the US, and for a lot of American biotech leaders who have not worked in Europe it’s a difficult thing to accept,” he says. “It’s a real possibility that an entire country will simply not allow access to a medicine, especially in many rare diseases.”

He adds that many companies have had to learn the unique difficulties in commercialisation in Europe through some challenging experiences.

“Building infrastructure in Europe takes a lot of investment – you need to hire people with skillsets across different countries, you need to build distribution infrastructure and you need to establish legal entities in many countries,” he says.

“I personally haven’t seen the type of change that I thought we would be facing in 2020 when I was imagining the future a few years ago”

“You have to do all that several times over just to access the EU. Meanwhile, the time to your first sale could be more than three years after a European regulatory review, and you’re still shouldering that entire infrastructure and all the costs associated with it during that time.

“A lot of emerging biotech companies have learned that the hard way, and many have learned that it’s better to schedule the timing of investments closer to the timing of revenues.”

Murthy stresses, though, that there are just as many opportunities for biotechs in the region as there are challenges – particularly as the sector moves toward highly specialised approaches to disease.

“We’re seeing a lot of interesting technologies focused purely on the biological mechanism of action behind the disease,” he says. “This is certainly true in the RNA field, and this new approach to medicine development has transformed Alnylam’s business.

“It affects how we do clinical trials and it affects the size of the commercial opportunities, because we can target very specific patients. Because of that, payers need to decide within the disease how to segment certain patient populations in order to maximise investments and get the best clinical benefit. That is quite disruptive, and I think that’s only going to continue.”

Murthy says this has also led to some innovative approaches to company formation.

“We’re now seeing a lot of biotechnology companies in Europe that are spinoffs of universities, based on platform technologies. This is great news – more biotechnology company creation leads to additional innovation, additional investments in research, and additional competition for European consumers.”

He also stresses the importance of partnering and collaborating with healthcare systems – which has only become more critical during the COVID-19 pandemic.

“The traditional model has always been somewhat transactional – we develop the medicine, they pay for it. Some of the more innovative biopharma companies are starting to blur those lines.

“Gene therapy is a great example, where you see proposals to engage in innovative, long-term payment models. These initial transactions are now leading to greater partnerships down the road.

“We believe there’s a need for more tailored agreement types like these that address uncertainty whilst limiting complexity and burden for payers. For example, we’ve created a value-based agreement framework for our new medicine for acute hepatic porphyria. This combines payment based on performance with additional financial mechanisms that address the short-term need to ensure payer value for money with the long-term view of budget responsibility, ensuring that what is committed to today is sustainable.”

Murthy adds: “Going forward, companies that want to be successful will need to find ways to be real partners in the development of medicines. That means investing in European research, partnering with European medical centres in developing medicines, and ensuring enrollment of European patients in clinical trials.”

A wide range of diseases

Alnylam’s work focuses on RNA interference therapeutics – which inhibit gene expression or translation by neutralising targeted mRNA molecules. Murthy notes that the field has become incredibly exciting over the last few years, and the company is hoping their new class of medicines will treat a range of diseases in the long-term.

“RNA interference is really a platform technology – it’s a naturally occurring biological process based on Nobel Prize winning research that began over 20 years ago. That basic understanding of biology is now transforming itself into real medicines. We’re only at the beginning.

“In the earlier stages of RNAi therapeutics, there were delivery challenges – how do you get these unstable RNAi molecules into the body without them degrading? Tremendous advances in biology, chemistry, and delivery of medicines have allowed us to go from applications that would require frequent infusions of high volumes of medicine to monthly or even quarterly subcutaneous injections.

“Now that we’ve cracked that delivery problem, the road is endless in terms of the number of diseases that we could address. We have announced research programmes in the CNS space, and have programmes in diseases ranging from hypercholesterolemia to pediatric diseases affecting the kidney. There are very few companies that could say that.”

And for a company that often deals with rare genetic diseases, the digitisation of healthcare services, delivery, and research has been a powerful boon.

“The biggest challenge with these conditions is often finding patients who are out there in the community. It’s unfortunate because they’re suffering when a treatment is already available, but you don’t find them until physicians can put the clues together.

“The digitisation of medical records and the ability, for example, to retrospectively screen records using risk factors or algorithms with propensity scores to find these people, has the potential to transform how physicians diagnose their diseases.”

However, Murthy says that while in other areas of digital health there are a lot of exciting concepts, he does not see much translation of those concepts into real practice.

“Fundamentally, the way most biopharma companies develop medicines hasn’t changed that much. In order for them to truly change, you need to look at the regulatory frameworks around research and development.

“I personally have not seen the type of change that I would have thought we would be facing in 2020 when I was imagining the future a few years ago.”

COVID and beyond

Alnylam has even been able to leverage its RNAi technology for a candidate to treat COVID-19, in partnership with Vir Biotechnology. The companies are aiming to move the asset into clinical trials at the end of the year.

“That has been a very rapid development process. In general, it has been tremendously exciting to see so many companies looking into developing or repurposing drugs to fight the pandemic.

“We’ve also noticed much more cooperation in the sector. Our president of research mentioned that it’s not uncommon for him to get a call from his counterpart in another company asking to compare notes in areas where we have expertise. That level of collaboration is really unprecedented.”

Conventional wisdom might say that the sector’s work during the pandemic will change how people view the industry for the better – but Murthy says there is some way to go in changing the appreciation of pharma’s value in Europe, and he hasn’t seen a noticeable shift yet.

“I hope that changes, but at the moment most of the recognition is framed around what the industry could bring to the economy for member states.

“When we meet with payers or government authorities, I’m frequently asked how many people we employ in their country, what our contribution to their GDP is, etc. If you are a small research-based biotechnology company, completely dependent on investment capital because you’re trying to bring forward cutting edge science, by definition you’re not going to be a major employer.

“If that is the standard by which European Union member states value our sector, that’s really going to devalue basic scientific innovation.”

Nevertheless, Anant says it’s important for people working in this industry to push themselves outside of their comfort zone if they want to make a difference in Europe.

“That’s how you really make an impact. Of course, that means there’s a chance you may fail because you’re going to be doing something that you’ve never done before – but that’s where the real opportunities lie.”

About the interviewee

Dr Anant MurthyDr Anant Murthy is currently a vice president at Alnylam Pharmaceuticals where he is the head of the MidSize Market Region, comprising Canada, the Nordics, Netherlands, Belgium, Luxembourg, and Portugal. In addition, he is the managing director of Alnylam Netherlands. Murthy is also the head of market access, pricing, and public policy, overseeing the company’s interactions with payers and governments across the European Union and Canada. He has led Alnylam’s successful launch of the world’s first RNA-interference medicine in several countries.

About the author

Paul TunnahDr Paul Tunnah founded pharmaphorum in 2009, which combines industry leading publications (www.pharmaphorum.com) with a specialist strategy and content marketing/communications consultancy (www.pharmaphorumconnect.com). He is a recognised author, speaker and industry advisor on content marketing, communications and digital innovation, having worked with many of the world’s leading pharmaceutical companies and the broader ecosystem of healthcare organisations.

In June 2020, he became chief content officer for Healthware Group, a next-generation integrated consulting group that operates at the intersection of the transformation of commercial operations and digital health, offering a unique range of services combining design, strategy, communication and innovation with technology and corporate venturing.

Connect with Dr Tunnah at https://www.linkedin.com/in/paultunnah/ or https://twitter.com/ptunnah

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GSK to Acquire 10% stake in CureVac for $163M

Shots:

  • GSK will invest $163M (€150m) in CureVac for a 10% stake to collaborate for the research, development, manufacturing, and commercialization of up to five mRNA-based vaccines and mAbs targeting infectious disease pathogens excluding CureVac’s existing COVID-19 mRNA and rabies vaccines research programs
  • CureVac to receive $137M (€120m) as upfront, $34.3 (€30m) as one-time reimbursable payment and is eligible to receive up to $366M (€320m) as development and regulatory milestones, $435M (€380m) as commercial milestones along with royalties on product sales
  • CureVac will lead pre/clinical-development till P-I trial after which GSK will develop & commercialize the therapies. Moreover, CureVAc will receive R&D funding from GSK and will be responsible for the GMP manufacturing of the candidates as well as retain the commercialization rights for all products in selected countries

Click here to read full press release/ article | Ref: GSK | Image: Twitter




Eli Lilly Reports Results of Mirikizumab in P-III OASIS-2 Study to Treat Moderate to Severe Plaque Psoriasis

Shots:

  • The P-III OASIS-2 study involves assessing mirikizumab vs PBO & Cosentyx (secukinumab) in 1,465 patients with mod. to sev. PsO. The patients were randomized in a (4:4:4:1) ratio to one of the following induction and maintenance period treatments: mirikizumab (250mg) @ 0, 4, 8, 12wks. followed by 250 & 125mg, q8w starting @16wks; 300mg secukinumab @ 0, 1, 2, 3, 4wks. followed by 300mg, q4w starting @4wks.; PBO @ 0, 4, 8, 12 wks. followed by 250mg mirikizumab q4w starting @16wks. through 32wks. followed by q8w thereafter
  • Results: @16wks. sPGA(0,1) (79.7% vs 6.3% & 76.3%), PASI 90 (74.4% vs 6.3% & 72.8%); PASI 100 (37.7% vs 1.8% & 36.6%). In general, the study resulted in meeting its 1EPs and all key 2EPs vs PBO @16wks. and all key 2EPs vs Cosentyx (secukinumab) @16wks. (non-inferiority) and @52wks. (superiority)
  • Mirikizumab is an IgG4 mAb binding p19 subunit of IL-23 and being evaluated for immune diseases, including psoriasis, UC and CD

Click here to read full press release/ article | Ref: Eli Lilly | Image: Glassdoor




Oncorus Initiates P-I Study of ONCR-177 in Patients with Advanced/ Refractory Cutaneous Subcutaneous or Metastatic Nodal Solid Tumors

Shots:

  • Oncorus has initiated a P-I study assessing ONCR-177 as monothx. and in combination with Merck’s Keytruda in patients with advanced and/or refractory cutaneous, subcutaneous or metastatic nodal solid tumors
  • The P-I study enrolls ~21 cancer patients while P-II study enrolls patients to histology- specific expansion cohorts. The P-I study will evaluate the safety and tolerability and determine the recommended P-II dose and as preliminary anti-tumor activity of ONCR-177 as monothx. & combination therapy
  • The planned expansion cohorts will include patients with BC, SCCHN, and melanoma. ONCR-177 is an intratumorally administered oncolytic Herpes Simplex Virus (oHSV) viral immunotherapy and is armed with oHSV, IL-12, CCL4, FLT3LG, anti-PD-1 and anti-CTLA-4 designed to stimulate multiple arms of the immune system

Click here to read full press release/ article | Ref: Oncorus | Image: Pitt Innovation System




Medical Device CROs – The next Growth Opportunity

Over the past decade, numerous scientific and technological breakthroughs in the medical device industry have resulted in an accelerated pace of research and innovation within this domain. Further, the demand for high quality and efficient medical devices, driven by a growing geriatric population and increasing incidence of various chronic clinical conditions, is on the rise. However, one of the primary challenges faced by this industry is the complex and time-consuming product development lifecycle of a new medical device. Specifically, the clinical stage is exceedingly resource intensive, involving high costs and greater risks.Furthermore, new advancements have facilitated the development and enforcement of more informed regulatory guidelines and instructions to ensure the safety of medical devices. Subtle differences in regulatory guidelines across various geographical regions need to be considered by medical device developers in order to receive approval in different markets. This has further resulted in longer trials, higher costs (due to rise in patient enrollments), and increased time-to-market. In order to overcome the abovementioned challenges, medical device developers are actively outsourcing their clinical research and associated operations to specialized medical device CROs, which are known to have the required capabilities and expertise.

The medical device sector is one of the few businesses that has been relatively less impacted amidst the COVID-19 pandemic. Moreover, as the disease spreads, the demand for accurate diagnostic measures, medical devices (including handled scanners, and personal protective equipment (PPE)), and effective preventive and treatment solutions for COVID-19, is growing at a rapid pace. In this context, it is worth mentioning that the sales of handheld ultrasound / x-ray scanners and infrared thermometers have increased manifold, in compliance to social distancing guidelines. In fact, the medical device industry is presently overwhelmed with the need to develop and supply various types of products to cater to the ongoing COVID-19 testing initiatives, across the world. As more cases of the disease are identified, restrictions imposed on both national and international movement of goods are anticipated to impact the import / export of medical devices, as well. In order to address this problem, it is very important for MedTech manufacturers to be flexible in their operations, leveraging all applicable exemptions, and optimizing internal processes by fulfilling emerging needs through innovation. Further, in general, any strategy conceived / deployed in this crisis must be communicated in an effective manner, across both public and private stakeholders in the industry.[3]

Over 300 CROs presently offer a wide range of preclinical and clinical research-related services to medical device developers

It worth noting that more than 85% CROs offer clinical development services to sponsor companies. Further, the market is currently dominated by the presence of very small and small companies (less than 51 employees), that represent over 50% of the total players. In fact, in the past few years, the domain has witnessed the establishment of several start-ups.

MEDICAL DEVICE CROS – THE NEXT GROWTH OPPORTUNITY

More than 70% of medical device CROs are based in North America and Europe. Within North America, majority of the service providers are headquartered in the US, in fact, over 50% of preclinical service providers are US-based; whereas, in Europe, most of the CROs are distributed across France, Germany, Switzerland, Spain, Italy and Sweden. Further, a significant number of such players (30%) are headquartered in Asia-Pacific and other developing countries of the world.

Deal Making in Medical Device CRO Domain

The medical device CRO domain is witnessing significant consolidation activity since the past few years. This can be attributed to the rise in competition within this domain, which has further compelled medical device service providers to diversify their portfolios through mergers and acquisitions. More than 35 instances of mergers and acquisitions have been reported in this domain, during the period 2015 and 2020 (till mid-March).

Majority of the deals in this domain were acquisitions (92%). It is worth noting that, of the total number of acquirers, 58% were privately held firms, while the rest were public companies. However, majority (94%) of the acquired companies were private companies.

MEDICAL DEVICE CROS – THE NEXT GROWTH OPPORTUNITY

Medical Device CROs Market to Grow at a Healthy Rate in the Foreseen Future

Over the years, outsourcing has become an indispensable business strategy within the global medical devices market. Moreover, the increasing regulatory stringency worldwide, is causing many innovator companies to rely on the expertise of CROs to liaise regulators and handle the intricacies associated with product approval. According to our estimates, the overall medical device CRO market is anticipated to grow at an annualized rate of 6.4%. The demand for such contract services is likely to be driven by clinical stage operations (78%), with the maximum share of revenues expected to come in from clinical trial management services (68%), both in the short- and mid-long term. This is anticipated to be followed by data management services, which are expected to contribute to 16% of the total share by 2030. Other important service segments include regulatory services (5.9%) and consultancy services (4.4%).

MEDICAL DEVICE CROS – THE NEXT GROWTH OPPORTUNITY

The share of preclinical service providers is estimated to be over 20% of the overall market, with the largest share of revenues expected to come in from sterility and microbiology testing services (35%). This is likely to be followed by biocompatibility testing services (31%), and material characterization and analytical services (20%).

MEDICAL DEVICE CROS – THE NEXT GROWTH OPPORTUNITY

In the long term, service revenues for medical devices intended for the treatment of CNS disorders (14%) are expected to make up a relatively higher share of the market. This is attributed to the anticipated growth in number of clinical trials of devices targeting Parkinson’s disease, Schizophrenia and strokes. It is likely to be followed by revenues from services offered for devices intended for catering to cardiovascular disorders (12%), oncological disorders (11%) and bone disorders (6%).

In terms of service revenues generated across difference device classes, class III devices are presently estimated to be responsible for the largest share (48%) in the overall medical device CRO market, followed by class II (45%) and class I (7%) devices. As of 2020, the contribution of service providers in North America is likely to be the largest (41%) in the overall medical device CROs market. This is likely to be followed by stakeholders in Europe and the Asia-Pacific, representing 32% and 25% shares, respectively.

Visit this link for more Insights.

Medical Device CROs Market (2nd Edition), 2020 – 2030

You may also be interested in the following titles:

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  2. Continuous Manufacturing Market (Small Molecules and Biologics), 2020 – 2030
  3. Prefilled Syringe Fill / Finish Services Market, 2020-2030

The post Medical Device CROs – The next Growth Opportunity appeared first on Blog.

Zydus Initiates Adaptive P-I/II Clinical Study Evaluating its ZyCoV-D Against COVID-19 in India

Shots:

  • Zydus has commenced the adaptive P-I/II human clinical trials of its plasmid DNA vaccine, ZyCoV-D and reported its first human dosing
  • The Adaptive P-I/II dose escalation study will assess the safety, tolerability, and immunogenicity of the vaccine in ~1000 candidates across multiple clinical sites in India. The company has already manufacture clinical GMP batches of the vaccine candidate for the clinical trials
  • ZyCoV-D has demonstrated a strong immune response and a high level of neutralizing Abs in its preclinical studies

Click here to read full press release/ article | Ref: Zydus | Image: The Quint

Related News: Zydus to Initiate Clinical Trials Evaluating ZyCoV-D Vaccine Against COVID-19 in July 2020




Fill / Finish Services Industry: Impact of the Swelling Biopharmaceutical Pipelines

Biopharmaceuticals represent the most rapidly growing and high-value segment of the pharmaceutical industry. Growing at an annualized rate of ~12%, the industry stands tall with more than 5,000 biologics in development and over 300 FDA approved biologics, since 2002. Biologic drug development is characterized by high quality standards and a rapidly growing demand for novel and effective treatment options. Even though it is a technically challenging field, outsourcing has grown into a promising and prominent segment, especially for manufacturing and fill / finish operations. In spite of the fact that fill / finish services are one of the crucial stages of product development, these operations represent one of the most heavily outsourced activities in the pharmaceutical industry. Currently, it is estimated that about one-third of the total fill / finish operations are outsourced to contract service providers.

Impact of the Swelling Biopharmaceutical Pipelines on Fill / Finish Services Industry

What are the Opportunities for the Players Active in the Field?

Owing to the recent advances in the product development technologies and innovative drug products, there are multiple growth opportunities for companies providing fill / finish services to biopharmaceutical drug manufacturers. the demand for contract services continues to be driven by a variety of needs, including requirement of single use systems, rising adoption of RABS and isolator barriers, introduction of robotic solutions and automation, and carrying out fill / finish in diverse type of drug-delivery devices; these are some of the areas where developer companies claim to benefit from engaging the services of capable CMOs.

Impact of the Swelling Biopharmaceutical Pipelines on Fill / Finish Services Industry

Who are the Leading Players in the Industry?

There are more than 115 service providers actively providing fill / finish services for various biologics. In addition to fill / finish, these provide an array of services for late stage product development, including lyophilization, quality control testing, labeling, storage and distribution services. Further, the service providers can be distinguished on the basis of their headquarters, year of establishment, company size, location of fill / finish facilities, type of packaging used for filling, services offered in addition to fill / finish, scale of operation, type of biologics handled and other details related to the fill / finish capabilities of service providers (such as number of units filled per batch).

Impact of the Swelling Biopharmaceutical Pipelines on Fill / Finish Services Industry

How is the Industry Landscape Changing in Response to Increase in Demand?

Owing to the complexities related to the handling of biologics and the requirement of fully automated fill / finish equipment, several contract service providers have made significant investments for expanding their respective production capabilities and capacities. Certain players have also established new facilities to cater to the growing demand for both conventional biologics and novel biologics. Since 2013, the industry has witnessed about 70 such developments; of which more than 30% were associated with establishment of new facilities.  

Impact of the Swelling Biopharmaceutical Pipelines on Fill / Finish Services Industry

Further, since 2013 the industry has witnessed ~70 instances wherein players have joined hands to offer their combined services, including fill / finish of biologics. Several players have entered into mergers and acquisitions with other service providers in order to expand their service offerings.

Impact of the Swelling Biopharmaceutical Pipelines on Fill / Finish Services Industry

Do the Contract Service Providers have Enough Capacity to Fulfill the Current and Future Demand for Biologic Drug Products?

The global installed fill / finish capacity of companies providing contract services for biologics is estimated to be about 17 million units, per day (or per batch). The current global installed capacity is primarily driven by players operating at commercial scale, which together account for 85% of the installed fill / finish capacity.

Impact of the Swelling Biopharmaceutical Pipelines on Fill / Finish Services Industry

The demand for commercial biologics is driven by antibodies; this trend is likely to continue in future as well. Currently, vials are estimated to be the most prevalent format of packaging container. In addition, by 2030, majority of the demand is likely to come from biologics commercialized for oncological disorders.

Impact of the Swelling Biopharmaceutical Pipelines on Fill / Finish Services Industry

How will the Market Evolve in the Foreseen Future?

Owing to the surge in efforts for development of various types of biologic drugs, the overall opportunity for contract fill / finish service providers is significant. Overall the market is likely to grow at an annualized rate of over 10% till 2030 and be worth more than USD 4 billion.

Impact of the Swelling Biopharmaceutical Pipelines on Fill / Finish Services Industry

The current opportunity lies heavily with the service providers packaging biologic drug products in vials. Antibodies which represent the most prominent type of biologic are likely to continue to dominate this market in the future as well.

Impact of the Swelling Biopharmaceutical Pipelines on Fill / Finish Services Industry

To get a detailed information on the key players across different geographies, key performance indicators for the service providers, role of robotic fill / finish systems and ready-to-use primary packaging, and other key industry trends impacting this domain, visit this link

Biologics Fill / Finish Services Market

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  1. China Biopharmaceutical Contract Manufacturing Market, 2020 – 2030
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  3. Prefilled Syringe Fill / Finish Services Market, 2020-2030

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Clover Reports First Patient Dosing in P-III Trial with SCB-808 (biosimilar, etanercept) in China

Shots:

  • The P-III study involves assessing of SCB-808
    (SC) vs Enbrel (SC) in patients with ankylosing spondylitis (radiographic axial
    spondyloarthritis) to evaluate its safety, efficacy and PK
  • The company utilizes its Trimer-Tag technology
    platform to develop novel therapies targeting trimerization-dependent pathways
    and is also leveraging its cGMP biomanufacturing capabilities to develop biosimilars
  • SCB-808 is mAb being developed as a prefilled
    syringe ready-for-injection self-administered for the treatment of rheumatoid
    arthritis and other autoimmune diseases

Click here to read full press release/ article | Ref: GlobeNewswire| Image: Signbox