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—— Proof of preclinical data sotrovimab, authoritywithEdited in many countries around the world, Reserve Test the activity of all variants of interest, including key mutations in Omicron –
—— Data needs to be confirmed by further in vitro pseudovirus testing ——
London and San Francisco, December 2, 2021 (Global News Service)-GlaxoSmithKline Corporation (NYSE stock code:GlaxoSmithKline) And Vir Biotechnology, Inc. (NASDAQ:for) Today announced the update Bio Rxiv, Preprint server, preclinical data shows that sotrovimab, an investigational monoclonal antibody, retains activity against key mutations1 New Omicron SARS-CoV-2 variants (B.1.1.529), including those found at the sotrovimab binding site. The data was generated by testing pseudoviruses with specific individual mutations found in Omicron. To date, sotrovimab has demonstrated sustained activity against all test variants of interest and interest defined by the World Health Organization (WHO). The two companies are now completing in vitro pseudovirus testing to confirm sotrovimab’s neutralizing activity against all Omicron mutation combinations, and plan to provide an update before the end of 2021.
Vir CEO Dr. George Scangos said: “Sotrovimab was designed with mutant viruses in mind. By targeting highly conserved regions of the spike protein that are unlikely to mutate, we hope to solve the current SARS-CoV-2 virus and the inevitable future variants we anticipate. This assumption has been made once. It has been confirmed once again-as evidenced by preclinical data, it can continue to maintain activity against all test variants of interest and interest, including key mutations found in Omicron. We fully expect this positive trend Will continue and work quickly to confirm its activities against Omicron’s complete portfolio sequence.”
PhD. Hal Barron, GSK Chief Scientific Officer and President of R&D, said: “Since the beginning of the pandemic, we have been working with Vir to combine our scientific expertise and technology to provide durable treatment options for COVID-19 patients. Although very early, these preclinical data support our long-term The virus continues to mutate and sotrovimab retains its potential for activity. We are pleased that this treatment option is available to patients in the United States and many other countries, and we are working to expand the global reach.”
About Sotrovimab
Sotrovimab is an investigational SARS-CoV-2 neutralizing monoclonal antibody. The antibody binds to the epitope shared by SARS-CoV-2 and SARS-CoV-1 (the virus that causes SARS) on SARS-CoV-2, indicating that the epitope is highly conserved, which may make it more difficult to develop resistance. Sotrovimab combines Xencor’s Xtend™ technology and is also designed to achieve high concentrations in the lungs to ensure optimal penetration into the airway tissues affected by SARS-CoV-2 and extend the half-life.
Updated in vitro data, published in Bio Rxiv, Proving that Sotrovimab retains the SARS-CoV-2 virus defined by WHO and others including but not limited to Delta (B.1.617.2), Delta Plus (AY. 1 or AY.2), Mu (B.1.621) and Omicron (B.1.1.529) critical mutation.
About the Sotrovimab Clinical Development Program
- COMET-ICE: A phase 3, multicenter, double-blind, placebo-controlled trial investigating intravenous sotovizumab in adults with mild to moderate COVID-19 who are progressing Because of the high risk of serious illness, they do not need to be hospitalized or oxygen. The results of the final COMET-ICE trial conducted in a complete trial population of 1,057 participants showed that compared with placebo, there was a 79% reduction in hospital stays over 24 hours or deaths from any cause on day 29 (adjusted Relative risk reduction) (p<0.001), meeting the primary endpoint of the trial.Interim data published in New England Journal of Medicine October 27, 2021, the final data will be pre-released on November 8, 2021 Medicine Magazine.
- Comet tail: A phase 3, randomized, multicenter, open-label, non-inferiority trial of intramuscular (IM) and intravenous injection of sotovimab for early treatment of mild to moderate COVID-19 in high-risk non-hospitalized adults And pediatric patients (12 years and older). The primary endpoint of the trial was met, and the headline data showed that intramuscular injection of Sotovezumab was not inferior to high-risk groups, and its efficacy was similar to that of intravenous injection. The two companies plan to submit the complete COMET-TAIL data set to peer-reviewed journals for publication in the first quarter of 2022.
- COMET-PEAK: A phase 2, randomized, multi-center, parallel group trial that evaluates intravenous and intramuscular injections of sotovizumab in outpatients with mild to moderate COVID-19. To date, the data from the open label part B of the trial (500 mg IV and 500 mg IM) demonstrate the equivalence of the virological response between the IM and IV groups. The two companies plan to submit the complete COMET-PEAK data set to peer-reviewed journals for publication in due course.
- GSK and Vir are also cooperating to investigate the use of sotrovimab in uninfected immunocompromised adults to determine whether sotrovimab can prevent symptomatic COVID-19 infection. GSK and Vir are supporting research initiated by researchers and promoting scientific collaboration with experienced researchers and networks involved in the continuous care of immunocompromised patients to understand the preventive effects of sotrovimab in this population. The prevention plan will be discussed with regulatory agencies in due course.
About Sotovezumab Global Visit
- Sotrovimab is authorized for emergency use…
The full story can be found on Benzinga.com
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