Vir Biotechnology and GSK announce global expansion to Phase 3 of COMET-ICE study evaluating VIR-7831 for the treatment of COVID-19

GlaxoSmithKlineVir Biotechnology, Inc. (Nasdaq: VIR) and GlaxoSmithKline plc (LSE/NYSE: GSK) announced the global expansion to Phase 3 of the COMET-ICE (COVID-19 Monoclonal antibody Efficacy Trial - Intent to Care Early) study evaluating VIR-7831 for the early treatment of COVID-19 in patients who are at high risk of hospitalisation. VIR-7831 (also known as GSK4182136) is a fully human antiSARS-CoV-2 (Severe Acute Respiratory Syndrome coronavirus-2) monoclonal antibody that was selected based on its potential ability to neutralise the virus, kill infected cells, provide a high barrier to resistance, and achieve high concentrations in the lungs (the major site 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.

George Scangos, Ph.D., Chief Executive Officer of Vir, said: "The rapid achievement of this important milestone reflects the urgency with which we’re mobilising our resources in the hope of preventing the worst consequences of this deadly virus. VIR-7831 is an antibody with characteristics that may enable it to prevent hospitalisation or death via multiple mechanisms. We look forward to continuing to collaborate with GSK to accelerate its development."

Dr. Hal Barron, Chief Scientific Officer and President R&D, GSK, said: "Given the urgent patient need I am very pleased that we have progressed VIR-7831 from pre-clinical studies to a Phase 3 trial in only six months since announcing our collaboration with Vir. We believe this neutralising antibody's high barrier to resistance, notable effector function, and enhanced delivery into the lung suggest it has best-in-class potential in the fight against this global pandemic."

The Phase 3 portion of the COMET-ICE study will assess the safety and efficacy of a single intravenous infusion of VIR-7831 or placebo in approximately 1,300 non-hospitalised participants globally (670 patients in the treatment arm and approximately 670 patients in the placebo arm). The primary efficacy endpoint is the proportion of patients who have progression of COVID-19 as defined by the need for hospitalisation or death within 29 days of randomisation. Interim analyses are planned to evaluate safety, futility and efficacy, the results of which 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.

The COMET clinical development programme for VIR-7831 includes two additional trials - one for the treatment of hospitalised patients and another for the prevention of symptomatic infection. The companies also expect to start a Phase 1b/2a trial in late 2020 evaluating VIR-7832, a second investigational SARS-CoV-2 neutralising antibody that shares the same characteristics as VIR-783, plus enhanced effector function, which may confer additional efficacy in treatment or prophylaxis by stimulating a T-cell response.

About VIR-7831 / GSK4182136

VIR-7831 (GSK4182136) is a monoclonal antibody that has shown the ability to neutralise SARSCoV-2 live virus in vitro and in vivo. 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 for resistance to develop. VIR-7831/GSK4182136 has been engineered with the potential to enhance lung bioavailability and have an extended half-life.

About VIR-7832

VIR-7832 is a monoclonal antibody that has shown the ability to neutralise 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 for 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.

About the Vir and GSK Collaboration

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. The collaboration uses Vir’s proprietary monoclonal antibody platform technology to accelerate existing and identify new anti-viral antibodies that could be used as therapeutic or preventive options to help address the current COVID19 pandemic and future outbreaks. The companies will leverage GSK’s expertise in functional genomics and combine their capabilities in CRISPR screening and artificial intelligence to identify anti-coronavirus compounds that target cellular host genes. They will also apply their combined expertise to research SARS-CoV-2 and other coronavirus vaccines.

About Vir Biotechnology

Vir Biotechnology is a clinical-stage immunology company focused on combining immunologic insights with cutting-edge technologies to treat and prevent serious infectious diseases. Vir has assembled four technology platforms that are designed to stimulate and enhance the immune system by exploiting critical observations of natural immune processes. Its current development pipeline consists of product candidates targeting hepatitis B virus, influenza A, SARS-CoV-2, human immunodeficiency virus and tuberculosis.

About GSK

GSK is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer.

Most Popular Now

Johnson & Johnson announces advance purchase a…

Janssen Pharmaceutica NV, one of the Janssen Pharmaceutical Companies of Johnson & Johnson (NYSE: JNJ) (the Company), has entered into an agreement with the African Vacci...

Pfizer and BioNTech confirm high efficacy and no s…

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced updated topline results from analysis of 927 confirmed symptomatic cases of COVID-19 observed in their pi...

Pfizer-BioNTech announce positive topline results …

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that, in a Phase 3 trial in adolescents 12 to 15 years of age with or without prior evidence of SAR...

GSK to support manufacture of Novavax' COVID-19 va…

GSK has reached an agreement in principle with Novavax and the UK Government Vaccines Taskforce to support manufacturing of up to 60 million doses of Novavax' COVID-19 va...

Valneva reports positive Phase 1/2 data for its in…

Valneva SE, a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical n...

Clinical trial completion rates decline during COV…

Social distancing and lockdowns may have reduced the spread of COVID-19, but researchers from Penn State College of Medicine also report those actions may have affected c...

BioNTech provides update on vaccine production sta…

BioNTech SE today announced that the European Medicines Agency (EMA) approved the manufacturing of the COVID-19 vaccine drug product at the facility in Marburg. As part o...

COVID-19 convalescent plasma with greater antibody…

Convalescent plasma, the use of survivors' antibodies transfused into sick COVID-19 patients is safe and significantly improves clinical outcomes when using high levels o...

Pfizer and BioNTech request regulatory agencies ex…

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today requested amendments to the U.S. Emergency Use Authorization (EUA) of the Pfizer-BioNTech vaccine (BNT162b2) ...

Study identifies possible COVID-19 drugs - includi…

A team led by scientists in the Perelman School of Medicine at the University of Pennsylvania has identified nine potential new COVID-19 treatments, including three that ...

COVID-19 causes 'unexpected' cellular response in …

New insights into the immune response to SARS-CoV-2 infections could bring better treatments for COVID-19 cases. An international team of researchers unexpectedly foun...

Undetected coronavirus variant was in at least 15 …

A highly contagious SARS-CoV-2 variant was unknowingly spreading for months in the United States by October 2020, according to a new study from researchers with The Unive...