Grifols to Evaluate New Immunoglobulin Therapy Against COVID-19 in Spain

Shots:

  • The company to initiate the clinical trial assessing the safety and efficacy of its COVID-19 drug based on the Grifols’ immunoglobulin Gamunex-C and containing anti-SARS-CoV-2 polyclonal Abs from plasma donors who have recovered from the disease
  • The study is expected to be initiated in Feb’2021. The treatment will be administered in primary care centers in people who test positive for COVID-19, avoiding hospitalization due to the progression of the disease and complementing the vaccine in the early phase after vaccination
  • The Grifols immunoglobulin Gamunex-C (IV, IM, SC) has proven to be safe and efficacious in the prevention of diverse infectious diseases in an immunocompromised patient

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

The post Grifols to Evaluate New Immunoglobulin Therapy Against COVID-19 in Spain 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.

Moderna’s mRNA-1273 Receives the US FDA’s EUA Against COVID-19

Shots:

  • The US FDA has authorized EUA of mRNA-1273 vaccine against COVID-19 in individuals ≥18yrs. The delivery to the US govt. will begin imminently while Moderna will continue to gather additional data and plans to file BLA for full licensure in 2021
  • Allocation and distribution will be prioritized according to populations identified by the CDC’s ACIP. The Company expects to have b/w 100-125M doses available globally in the Q1’21, with 85-100M of those available in the US
  • The US govt. ordered total 200M doses to date & retains an option to purchase up to an additional 300M doses, ~20M doses will be delivered by the end of Dec 2020

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

The post Moderna’s mRNA-1273 Receives the US FDA’s EUA Against COVID-19 first appeared on PharmaShots.

Moderna’s mRNA-1273 Receives the US FDA’s Advisory Committee Vote Supporting EUA Against COVID-19

Shots:

  • The VRBPAC voted 20-0, with one abstention that the benefits of the Moderna’s vaccine outweighed its risks for use in people aged ≥18yrs
  • The recommendation is based on data analysis from the pivotal P-III clinical study that demonstrated 94.1% efficacy
  • The US FDA’s committees provide non-binding recommendations. The FDA will take the VRBPAC’s recommendation into consideration in making a final decision on approval

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

The post Moderna’s mRNA-1273 Receives the US FDA’s Advisory Committee Vote Supporting EUA Against COVID-19 first appeared on PharmaShots.

Pfizer & BioNTech Receives MHRA’s EUA for BNT162b2 Against COVID-19

Shots:

  • Pfizer & BioNTech reports that the MHRA in the UK has granted a temporary authorization for the EU for BNT162b2 against COVID-19. The distribution of vaccine will be prioritized according to the populations identified in guidance from the JCVI
  • The MHRA’s decision is based on a rolling submission, including data from the P-III study, demonstrating 95% efficacy in participants without & with/ out prior SARS-CoV-2 infection, in each case measured from 7 days after the second dose
  • This marks the first EUA following a WW P-III trial of a vaccine to combat the pandemic. The companies are anticipating further regulatory decisions across the globe in Dec’2020

Click here ­to­ read full press release/ article | Ref: Pfizer | Image: The Jakarta Post

The post Pfizer & BioNTech Receives MHRA’s EUA for BNT162b2 Against COVID-19 first appeared on PharmaShots.

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

The post Moderna Amends its Agreement with UK Government for an Additional 2M Doses of COVID-19 Vaccine first appeared on PharmaShots.

Bharat Biotech Initiates P-III Study for Covaxin Against COVID-19

Shots:

  • Following the successful completion of the interim analysis from the P-I & P-II clinical trials of Covaxin, the company has received the DCGI approval to conduct a P-III study of its COVID-19 vaccine
  • The study will assess Covaxin (6mcg, IM at an interval of 28days) vs PBO in ~26,000 volunteers in a ratio (1:1) aged ≥18yrs. in over 25 centers across India and is being conducted in partnership with ICMR. It is the largest clinical trial conducted for a COVID-19 vaccine in India
  • Bharat Biotech plans to launch Covaxin by June’2021, unless the government decides to give the vaccine a EUA before that, based on data from earlier phases of clinical trial

Source 1, Source 2 ­to­ read full press release/ article | Ref: Bharat Biotech, NDTV | Image: MediCircle

The post Bharat Biotech Initiates P-III Study for Covaxin Against COVID-19 first appeared on PharmaShots.

AstraZeneca Resumes P-III Study of AZD1222 Against COVID-19 in the US

Shots:

  • The US FDA authorizes the restart of the P-III clinical study in the US following the resumption of trials in other countries in recent weeks. The FDA reviewed all safety data from studies globally and concluded it was safe to resume the trial
  • A voluntary pause across all global studies was triggered on Sept 06, 2020, to allow the examination of safety data by independent monitoring committees. AstraZeneca has resumed the clinical trials across the globe with regulators in the US, UK, Brazil, South Africa, and Japan confirming that it was safe to do so
  • While trials are ongoing, AstraZeneca and Oxford University will continue to provide information to regulators, study investigators, and participants according to clinical trial and regulatory standards

Click here ­to­ read full press release/ article | Ref: AstraZeneca | Image: The Indian Express

The post AstraZeneca Resumes P-III Study of AZD1222 Against COVID-19 in the US first appeared on PharmaShots.

Sanofi and Translate Bio to Advance MRT5500 into Clinical Study Against COVID-19

Shots:

  • The companies reported the preclinical results of MRT5500 demonstrating the potential of the vaccine in neutralizing the Abs against SARS-CoV-2. The two doses of MRT5500 induced neutralizing antibody levels significantly higher than those observed in COVID-19 patients
  • The preclinical data support the advancement of MRT5500 for clinical development. The companies anticipate the initiation of P-I/II study in Q4’20
  • MRT5500 is being developed under the collaboration between Sanofi Pasteur and Translate Bio and has demonstrated its ability to elicit an immune response in both mice and non-human primates in a preclinical study

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

The post Sanofi and Translate Bio to Advance MRT5500 into Clinical Study Against COVID-19 first appeared on PharmaShots.

AbbVie and Harvard University Collaborate to Develop Novel Therapies Against Emergent Viral Diseases

Shots:

  • AbbVie and Harvard University enter a $30M research alliance to study & develop novel therapies against emergent viral infections with an initial focus on coronavirus and the viruses leading to hemorrhagic fever
  • The focus of the collaboration is to integrate fundamental biology into the pre/clinical development of new therapies for viral diseases
  • AbbVie will deploy expertise and facilities to advance collaborative research and early-stage development efforts across five program addressing multiple therapeutic modalities: immunity and immunopathology, host targeting for antiviral therapies, antibody therapeutics, small molecules, and translational development

Click here ­to­ read full press release/ article | Ref: AbbVie | Image: RMIT University

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

Regeneron Collaborates with Roche to Improve the Global Supply of REGN-COV2 Against COVID-19

Shots:

  • The two global companies collaborated to develop, manufacture, and distribute REGN-COV2 across the globe. The agreement is expected to increase the supply of REGN-COV2 to at least 3.5 times the current capacity with the potential for expanding it further
  • Regeneron will lead the distribution in the US while Roche will be responsible for the distribution outside the US, both will bear distribution expenses in their designated territories. Each partner will dedicate a manufacturing capacity to REGN-COV2 every year while the collaborators have started the technology transfer process
  • The partners will jointly fund and execute the ongoing P-III prevention and P-I healthy volunteers safety studies as well as additional global studies to assess the potential for REGN-COV2 against COVID-19. Additionally, Roche will solely responsible for the initial EMA’s approval or conducting any additional studies required for approval outside the US

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

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




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




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




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