VIR-7831 Antibody Description
VIR-7831 (GSK4182136) is a fully human anti-SARS-CoV-2 monoclonal antibody that was selected based on its potential to neutralize the virus in vitro, kill infected cells, provide a high barrier to resistance, and achieve high concentrations in the lungs (one of the major sites of infection).
Vir Biotechnology's antibody binds to an epitope on SARS-CoV-2 that is shared with SARS-CoV-1 (also known as SARS), indicating that the epitope is highly conserved, which may make it more difficult for escape mutants to develop.
In April 2020, Vir and GSK entered into a collaboration to research and develop solutions for coronaviruses, including SARS-CoV-2, the virus that causes COVID-19.
VIR-7832 is a monoclonal antibody that has shown the ability to neutralize SARS-CoV-2 live virus in vitro. The antibody binds to an epitope on SARS-CoV-2 that is shared with SARS-CoV-1 (also known as SARS), indicating that the epitope is highly conserved, which may make it more difficult to escape mutants to develop. VIR-7832 has been engineered with the potential to enhance lung bioavailability, have an extended half-life, and function as a therapeutic and/or prophylactic T cell vaccine.
A phase 2/3 clinical study was launched on September 10, 2020, in which subjects with coronavirus disease 2019 (COVID-19) will receive VIR-7831 or placebo and will be assessed for safety, tolerability, efficacy, and pharmacokinetics. Initial Phase 3 results may be available as early as the end of 2020; results for the primary endpoint are expected in the first quarter of 2021, with current estimates at January 2021.
A manuscript developed by Vir in collaboration with the MRC-University of Glasgow Centre for Virus Research, published on November 5, 2020, "shows that the receptor-binding motif of SARS-CoV-2, a major target of neutralizing antibodies, is evolving at a higher rate than the rest of the receptor-binding domain and spike, and is resilient to change,” said Herbert “Skip” Virgin, M.D., Ph.D., chief scientific officer of Vir, in a press release.
“It is reminiscent of our experience with influenza A, where the mutability of the region targeted by the most potent neutralizing antibodies results in ineffective immunity year-over-year. Our demonstration of a virulent SARS-CoV-2 immune evasion mutant provides a cautionary tale for how we address this pandemic, and indicates the importance of ongoing surveillance for immune evasion mutations in the development of antibodies and vaccines.”
VIR Bio is a California-based clinical-stage immunology company focused on combining immunologic insights with cutting-edge technologies to treat and prevent serious infectious diseases. 'We engineer the fully-human antibodies that we discover to enhance their therapeutic potential,' says the company's website.
VIR-7831 Antibody Indication
VIR-7831 is being evaluated for the early treatment of COVID-19, a disease caused by the SARS-CoV-2 virus in patients who are at high risk of hospitalization.
No pediatric or pregnancy efficacy has been disclosed.
VIR-7831 Antibody News
November 10, 2020 - George Scangos, Ph.D., chief executive officer of Vir Bio said in a press release: “We expect to share initial results from the trial as early as January and look forward to advancing VIR-7831 into new patient populations alongside the initiation of Phase 1b/2a trial for our second investigational SARS-CoV-2 neutralizing antibody, VIR-7832."
November 6, 2020 - California based Vir Biotechnology, Inc. announced the publication of new research demonstrating that the immunodominant SARS-CoV-2 receptor binding motif (RBM) is the least conserved region in the SARS-CoV-2 spike protein, allowing for the occurrence of mutations without disrupting human ACE2 (hACE2) binding, which mediates viral entry. Researchers also characterize the virulence and fitness of N439K, a prevalent variant in the RBM that demonstrated resistance to human neutralizing monoclonal antibodies (mAbs), including one that is currently being evaluated in clinical trials.
October 8, 2020 - Study published by Nature: Fc-optimized antibodies elicit CD8 immunity to viral respiratory infection.
September 24, 2020 - RESEARCH ARTICLE: Ultrapotent human antibodies protect against the SARS-CoV-2 challenge via multiple mechanisms.
October 6, 2020 - Vir Biotechnology and GSK announce the global expansion to Phase 3 of COMET-ICE study evaluating VIR-7831 for the treatment of COVID-19. VIR-7831 (also known as GSK4182136) is a fully human anti-SARS-CoV-2 (Severe Acute Respiratory Syndrome coronavirus-2) monoclonal antibody that was selected based on its potential to neutralize the virus, kill infected cells, provide a high barrier to resistance, and achieve high concentrations in the lungs (one of the major sites of infection). Following a positive assessment of unblinded safety data from the lead-in portion of the trial by an Independent Data Monitoring Committee on September 30, 2020, the COMET-ICE registrational study will now expand globally to additional sites in North America, South America and Europe.
September 16, 2020 - Study published by Cell: Mapping Neutralizing and Immunodominant Sites on the SARS-CoV-2 Spike Receptor-Binding Domain by Structure-Guided High-Resolution Serology.
August 31, 2020 - Vir Biotechnology, Inc. and GlaxoSmithKline plc announced that the first patient was dosed last week in a phase 2/3 study with VIR-7831 (also known as GSK4182136), a fully human anti-SARS-CoV-2 (Severe Acute Respiratory Syndrome coronavirus-2) monoclonal antibody, for the early treatment of COVID-19 in patients who are at high risk of hospitalization.
May 18, 2020 - Study published in Nature: Cross-neutralization of SARS-CoV-2 by a human monoclonal SARS-CoV antibody.
April 21, 2020 - Study: Developing therapeutic monoclonal antibodies at pandemic pace.
VIR-7831 Clinical Trials
The Company announced on November 10, 2020, it plans to initiate two additional Phase 3 trials in the COMET clinical development program for VIR-7831:
- A trial for the treatment of hospitalized adults with COVID-19 is planned as a sub-study of the National Institutes of Health-sponsored ACTIV-3 trial and is expected to begin as soon as regulatory and ethical approvals are in place.
- A trial for prophylaxis or prevention of symptomatic infection is expected to begin in the first quarter of 2021.
Clinical Trial NCT04545060: A Randomized, Multi-center, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of Monoclonal Antibody VIR-7831 for the Early Treatment of Coronavirus Disease 2019 (COVID-19) in Non-hospitalized Patients. Last Update Posted: October 29, 2020.
- This is a phase 2/3 study in which subjects with coronavirus disease 2019 (COVID-19) will receive VIR-7831 or placebo and will be assessed for safety, tolerability, efficacy, and pharmacokinetics.