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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Incyte Collaborates with Cellenkos for CK0804 to Treat Myelofibrosis

Shots:

  • The companies collaborated to evaluate ruxolitinib in combination with CK0804 in patients with MF and plan to initiate a P-Ib study. Incyte will fund the study while operationalized by Cellenkos
  • Cellenkos to receive $20M as licensing fee, ~$294.5M as development, regulatory and commercialization milestones along with royalties on sales of therapies, if approved. Incyte has an exclusive option to acquire sole rights to develop and commercialize CK0804 in benign and malignant hematology indications
  • Following the exercising the global license option, Incyte to lead all activities and costs associated with research, development, and commercialization of the program

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

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Zai Lab Signs an Exclusive License Agreement with Cullinan Oncology for the Development and Commercialization of CLN-081 in Greater China

Shots:

  • Cullinan will receive $20M up front and is eligible to receive ~$211M in development, regulatory and sales-based milestone payments
  • Cullinan is also eligible for high-single-digit to low-teen tiered royalties based on sales of CLN-081 in Greater China includes Hong Kong, Macau and Taiwan
  • CLN-081 is an orally available, small-molecule, irreversible EGFR inhibitor, which is currently in P-I/IIa dose escalation and expansion trial for NSCLC patients

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

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Gilead Amends Agreement with Galapagos for Development and Commercialization of Jyseleca (filgotinib)

Shots:

  • Following the FDA Type A meeting, Gilead will not pursue the approval of Jyseleca for RA in the US. Galapagos will be solely responsible in EU for Jyseleca (200/100mg) in RA and UC + all future indications for which Gilead will receive royalties on EU sales initiating in 2024
  • Galapagos to receive $194.6M, which will be split b/w $133.7M in 2021 & $60.8M in 2022 for the ongoing development and accelerated commercial buildout in the EU
  • Additionally, Galapagos will assume responsibility for ongoing clinical trials evaluating filgotinib in RA. Gilead will retain commercial rights for filgotinib outside the EU, including in Japan where filgotinib has recently been approved and is co-marketed with Eisai

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

The post Gilead Amends Agreement with Galapagos for Development and Commercialization of Jyseleca (filgotinib) first appeared on PharmaShots.

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

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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

The post Astellas Collaborates with KaliVir to Develop and Commercialize VET2-L2 first appeared on PharmaShots.

Evotec Collaborates with Rappta Therapeutics to Focus on Oncology Target

Shots:

  • Evotec to receive research funding & is eligible for milestones. Evotec will support Rappta’s program of developing small molecule activators of the enzyme PP2A
  • The collaboration leverages Evotec’s integrated platform for drug discovery and development and its oncology expertise coupled with state-of-the-art technologies
  • PP2A is a serine/threonine phosphatase that functions as a tumor suppressor by negatively regulating multiple oncogenic signaling pathways responsible for driving cancer progression

Click here ­to­ read full press release/ article | Ref: Evotech | Image: Personal Financial

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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

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Roche and Prothena to Advance Prasinezumab in P-IIb Study for Patients with Early Parkinson’s Disease

Shots:

  • The companies will advance the prasinezumab into a P-IIb study in patients with early Parkinson’s disease based on positive signals of efficacy consistent with disease modification in the PASADENA study
  • The study is designed to further assess the efficacy of prasinezumab by expanding upon the patient population enrolled in PASADENA study to include patients with early Parkinson’s disease on stable levodopa therapy and is expected to initiate in 2021
  • Prasinezumab is the first anti-alpha synuclein Ab to advance into late-stage development. Additionally, Prothena will earn a $60M clinical milestones upon the first patient dosed in the study

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

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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

Insights+ KOL Articles: The New Normal and Covid-19 Vaccine Development

Since the virus outbreak in China, all eyes are on the most awaited Covid-19 vaccine offering a glimmer of hope. Abide by social distancing, wearing a mask, and frequent hand washing – until we have a vaccine. This new mantra amidst all misery has created hope in the hearts of many. We have to accept the “new normal” until we have a vaccine.

What is a Vaccine?

Vaccines, in a way, activate the immune system without the disease. Getting a particular vaccine is somewhat like having survived the disease once, without the health burden. Vaccines can be made with weakened viruses, inactivated viruses, and protein from a virus or even just the biological material (mRNA).

How Do Vaccines Provide Immunity?

Immunity is the body’s defense mechanism is to resist the effects of a microorganism. Immunity induced by a vaccine is weaker than that induced naturally after an infection. After you get a vaccine shot, your body will develop long-lasting antibodies that circulate in the blood. Such virus-specific antibodies will help to prevent severe disease. The vaccine will not prevent the entry of the virus into the body (infection), but it will prevent severe infection.

Vaccine Development

Scientists have gone from the discovery of the virus to more than 165 candidate vaccines in record time, with 27 vaccines already in clinical trials.

Challenges in Vaccine Development

  • Laboratory development & Preclinical testing
  • Large Clinical Trials
  • New technology for production
  • Availability: manufacturing millions of doses especially of a novel coronavirus
  • Developing an integrated and fair plan for vaccine distribution
  • Order of priority – health workers, elderly, and those with underlying conditions
  • Logistic –storage temperature
  • Resistance from the public – lack of awareness
  • Supply to rural areas
  • Multiple-dose may be needed

When Can We Expect A Vaccine And How Has Development Been Stepped Up?

Vaccine development normally takes years to complete, but the continuing crisis has prompted the multilateral system to accelerate the process. Regulatory approvals are up to speed but no important stages are skipped. This means that different tests of the vaccine are conducted in “parallel”.

The pandemic situation requires multiple activities and tests to be conducted at financial risk to stakeholders without knowing whether the vaccine candidate will be safe and effective.

Clinical Status of Vaccines Around the Globe

Research in India

The Indian government agency is working at lightning speed to test and approve an Indian origin COVID-19 vaccine. The government has permitted six Indian companies to develop vaccines against COVID-19. Recently, Bharat Biotech and Zydus Cadila were granted permission to start Phase I and II human clinical trials of their most advanced vaccines, named COVAXIN and ZyCoV-D respectively.

India Will Be The Manufacturer of The Covid-19 Vaccine

India is known for its mass manufacturing of pharmaceuticals. Leading international bodies like the World Health Organisation and the Bill and Melinda Gates Foundation to obtain their vaccines from India. Now is the time when India can definitely leverage its ability to mass-produce a Covid-19 vaccine whenever it is ready and also help reduce the price of these vaccines. Reasonable price provided by India`s mass production ability would be the only factor in assuring the Covid-19 vaccine’s access across the globe.

Serum Institute of India (SII) located in Pune has entered a manufacturing partnership with British pharmaceutical giant AstraZeneca to produce and supply 1 billion doses of the Covid-19 vaccine. These vaccines will be for India and middle- and low-income countries across the world (GAVI countries).

What Happens If You Choose Not To Get A Vaccine?

Firstly, you will not be protected from the deadly respiratory disease and may end up suffering from a severe infection. Secondly, refusal by many people might not get the country to herd immunity.

What Lies In The Future?

Even when a vaccine is introduced, we will have several months of significant infection or at least a risk of infection to take care of. This means that we may have to face more months under the threat of the novel coronavirus than we have already survived. If precautions are not taken and guidelines are not followed, there will continue to be more outbreaks, more deaths. The availability of the vaccine will be the slow start of the flattening of the curve. The total time taken to completely flatten the curve cannot be predicted, as it depends on awareness, accessibility, affordability, and adoption. With the world joining hands to find a vaccine for Covid-19, all eyes are on India, the powerhouse of vaccine manufacturing. It is a race between humans and the virus, rather than between countries or pharmaceutical companies.

Conclusion

Putting an end to this viral disaster with a vaccine has led to a global vaccine race to coherently extinguish Covid-19. Each week brings news on early success, low cost, fast track results, promising effects because of vaccine optimism. There is too much uncertainty that continues to be pondered upon. The vaccine won’t extinguish the disease itself but offer protection and immunity. It certainly will not immediately return life to “old normal”. The virus is too widespread but the vaccine could make Covid-19 easier to live with and prevent severe cases.

Finally, there seems to be a ray of hope amidst this tunnel of misery!

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Dr. Anish Desai

Dr. Anish Desai is a trained Clinical Pharmacologist and Pharmaceutical Physician with 3 decades of experience in Academia, Research, and Healthcare industry with proven leadership skills, strong business acumen, and a deep understanding of the Healthcare System, including Pharmaceutical, Nutraceutical & Medical device industry. He has been recognized for driving positive change, delivering solutions, developing talent, and nurturing strong relationships with external stakeholders. Holding Senior Management Position for the last 20 years and involved in strategic decision making. ‘IntelliMed Healthcare Solutions’ is a Healthcare startup launched by him with an intent to focus on strategic medical affairs for business growth, thereby infusing science into business. IntelliMed specializes in scientific, Clinical & medical support from conceptualization/Ideation to launch.

Sunaina Anand

Dr. Sunaina Anand, Pharm. D is a Clinical Pharmacist. She currently serves as Medical Affairs Executive in IntelliMed Healthcare Solutions. She previously interned in Tata Memorial Hospital and Columbia Asia Hospital, Bengaluru.

Related Post: Insights+ KOL Articles: Immunity & Pregnancy: Unique and Complex

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Ovid Therapeutics and University of Connecticut Collaborate to Accelerate the Development of OV101 (gaboxadol) for Angelman Syndrome

Shots:

  • Ovid will collaborate with UConn’s Stormy J. Chamberlain and secures exclusive access to identified genetic sequences for shRNA-based therapy. Ovid plans to leverage its translational medicine capabilities and drug development expertise in Angelman syndrome to advance OV101 into clinical
  • Ovid is developing OV101 for Angelman syndrome to restore tonic inhibition addressing several core symptoms of the disease. OV101 is currently being evaluated in P-III NEPTUNE study with expected results in Q4’20
  • Additionally, Ovid is exploring OV881, a microRNA approach that may reduce the expression of UBE3A-antisense and restores UBE3A expression while the company is developing OV935 (soticlestat) in collaboration with Takeda for rare developmental and epileptic encephalopathies (DEE)

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