Novavax Initiates Pediatric Expansion for Phase 3 Clinical Trial of COVID Vax

 PREVENT-19 clinical trial expanded to assess the efficacy, safety and immunogenicity of NVX-CoV2373 for the prevention of COVID-19 in up to 3,000 12-17-year-old adolescents

- President of Research and Development, Gregory Glenn, M.D., to provide update regarding the additional trial arm during World Vaccine Congress

Novavax, Inc. (Nasdaq: NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that it has initiated a pediatric expansion of its Phase 3 clinical trial for NVX-CoV2373, the company's recombinant protein vaccine candidate against COVID-19. The additional arm of the ongoing PREVENT-19 pivotal trial will evaluate the efficacy, safety and immunogenicity of NVX-CoV2373 in up to 3,000 adolescents aged 12-17 across up to 75 sites in the United States.

Participants will randomly receive either the vaccine candidate or placebo in two doses, administered 21 days apart. Two-thirds of volunteers will receive intramuscular injections of the vaccine and one-third will receive placebo. A blinded crossover is planned to take place six months after the initial set of vaccinations to ensure that all trial participants receive active vaccine. Participants will be monitored for safety for up to two years following the final dose.

https://finance.yahoo.com/news/novavax-initiates-pediatric-expansion-phase-125100550.html

Cocrystal Pharma Update on COVID-19 Antiviral Program

  Cocrystal Pharma, Inc. (Nasdaq: COCP), (“Cocrystal” or the “Company”), a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication machinery of influenza viruses, coronaviruses, hepatitis C viruses and noroviruses, announces progress in developing broad-spectrum antiviral drug candidates that target coronaviruses including SARS-CoV-2, the coronavirus that causes COVID-19. Cocrystal initiated its COVID-19 program in March 2020 and has since expanded the program with additional development and licensing.

“We are aggressively developing novel coronavirus protease inhibitors for COVID-19 prophylactic and therapeutic use,” said Sam Lee, Ph.D., President of Cocrystal. “These drug candidates bind to a highly conserved region of the active site of SARS-CoV-2 protease that is required for SARS-CoV-2 viral replication. Our high-resolution x-ray cocrystal structures further confirmed the specific covalent interaction with this conserved region of the proteases of the coronaviruses SARS-CoV-2, SARS-CoV and MERS-CoV viruses.

“We believe that, due to their novel mechanism of action, our protease inhibitors are likely to be effective against new variants of SARS-CoV-2. This may include the recent variants first identified in the United Kingdom, South Africa, Brazil and India, which may be more contagious forms of the virus and may evade immunity produced by vaccines or previous infection,” he added.

https://finance.yahoo.com/news/cocrystal-pharma-provides-covid-19-120000496.html

Ocugen studies: COVAXIN potentially effective against three key variants of SARS-CoV-2

 

• COVAXIN effectively neutralizes Brazil variant along with UK variant and India double mutant variant
  
  

• Potential effectiveness against multiple variants reduces the possibility of mutant virus escape
  
  

• According to World Health Organization, the double mutant variant of SARS-CoV-2 has spread to at least 17 countries
  

Ocugen, Inc. (NASDAQ: OCGN), a biopharmaceutical company focused on discovering, developing, and commercializing gene therapies to cure blindness diseases and developing a vaccine to save lives from COVID-19, today announced that in a new study, scientists at Indian Council of Medical Research (ICMR)-National Institute of Virology have found that COVAXIN demonstrated potential effectiveness against the Brazil variant of SARS-CoV-2, B.1.128.2. As previously disclosed, a study conducted by ICMR also suggested that COVAXIN was effective against the UK variant, B.1.1.7, as well as the Indian double mutant variant, B.1.617. It is notable that the Brazilian variant, B1.128.2, contains the E484K mutation that was found in New York.

In the ICMR studies, COVAXIN-vaccinated sera effectively neutralized several SARS-CoV-2 variants (B.1.617 (India, double mutant), B.1.1.7 (United Kingdom), B.1.1.28 (Brazil P2), and heterologous strain) in an in-vitro plaque reduction neutralization assay. These studies suggest that COVAXIN vaccination may be effective against multiple SARS-CoV-2 variants.

https://finance.yahoo.com/news/ocugen-announces-studies-showing-covaxin-113000104.html

Vaxart Q1 results and business update

 

• Vaxart to advance three oral tablet COVID-19 vaccine candidates to the clinic: VXA-CoV2-1 (includes both the S and the N proteins) into Phase II and two S-only constructs into Phase I/II
  

• Four clinical trials of the oral norovirus vaccine candidate to be initiated in 2021

• Cash, cash equivalents, and marketable securities of $177.3 million as of March 31, 2021

Vaxart, Inc. (Nasdaq: VXRT), a clinical-stage biotechnology company developing oral vaccines that are administered by room-temperature stable tablet rather than by injection, today reported financial results for the first quarter ended March 31, 2021 and provided a corporate update. As part of this update, the Company announced that it plans to initiate several clinical and pre-clinical COVID-19 vaccine studies as it continues the development of its multivariant COVID-19 vaccine candidate portfolio.

“The recent results of a poll we commissioned suggested that as many as 19 million more Americans would decide to get vaccinated against COVID-19 if the vaccine was administered as a pill instead of a needle injection — a number we expect to be much higher worldwide, particularly given the distribution advantages of a room-temperature stable tablet. That alone could potentially make a significant global impact,” said Andrei Floroiu, Chief Executive Officer of Vaxart.

“Additionally, we expect our vaccine to have a different profile – on safety, tolerability, and immunogenicity – than those of injectable vaccines,” added Floroiu. “Our vaccines employ a novel mechanism of action — validated by clinical results against flu — that is very different than those of injectable vaccines, thus offering the potential to complement, if not replace, injectable vaccines.”

https://finance.yahoo.com/news/vaxart-reports-first-quarter-2021-120000965.html

Denali: Positive Results in Early Stage Studies of Parkinson’s Treatment

 

• Treatment with BIIB122/DNL151 achieved robust reductions in biomarkers of target engagement and pathway engagement in healthy volunteers and patients with Parkinson’s disease
  

• BIIB122/DNL151 demonstrated a safety profile supporting continued development in patients with Parkinson’s disease

• Data support once daily oral dosing with BIIB122/DNL151

• Denali and Biogen plan to advance BIIB122/DNL151 into late-stage development in patients with Parkinson’s disease by year-end 2021

https://finance.yahoo.com/news/denali-therapeutics-presents-positive-results-130000554.html

Novartis biosimilar targets rivals' Eylea eye treatment

 Novartis's generics arm Sandoz is set to enrol patients with neovascular age-related macular degeneration (nAMD) in a late-stage trial of a biosimilar version of Bayer and Regeneron's Eylea, Novartis said on Monday.

The nAMD condition accounts for 10% of age-related macular degeneration cases, but is responsible for 90% of AMD-related blindness, the Swiss group said.

Aflibercept, the generic name for Eylea, is indicated to improve eyesight in patients with nAMD and other specific neovascular retinal diseases.

Biosimilars are essentially cut-rate generic versions of biologic drugs. Sandoz has eight biosimilars on the market and around 15 more in the pipeline.

https://finance.yahoo.com/news/novartis-biosimilar-targets-rivals-eylea-054211796.html

Moderna in Supply Agreement with Gavi for up to 500M Doses of Vaccine

 34 million doses to begin delivery in the fourth quarter of 2021

Option granted to COVAX Facility for up to 466 million additional doses in 2022

Doses provided at lowest tiered price, in keeping with Moderna’s global access principles commitment

Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced an agreement with Gavi, the Vaccine Alliance to supply up to 500 million doses of the COVID-19 Vaccine Moderna, including an initial 34 million doses to be delivered in the fourth quarter of 2021. Through this agreement, on behalf of the COVAX Facility, Gavi also retains the option to procure 466 million additional doses in 2022. All doses are offered at Moderna’s lowest tiered price, in line with the Company’s global access commitments.

This agreement covers the 92 Gavi COVAX Advance Market Commitment (AMC) low- and middle-income countries. The Company is in discussions to allocate and supply to self-financing participants in the future. COVAX is a global initiative co-led by Gavi, the Vaccine Alliance (Gavi), the Coalition for Epidemic Preparedness Innovations (CEPI) and the World Health Organization (WHO), to ensure equitable access to COVID-19 vaccines for all countries, regardless of income levels.

On April 30, the World Health Organization (WHO) issued an Emergency Use Listing (EUL) for Moderna’s COVID-19 vaccine to prevent COVID-19 in individuals 18 years of age and older.

https://finance.yahoo.com/news/moderna-announces-supply-agreement-gavi-100000854.html