EMA Reviews GSK and Vir’s Monoclonal Antibody for COVID-19 Treatment

GSK and Vir Biotechnology have announced that the EMA has started a review of the dual-action monoclonal Antibody VIR-7831 for the early treatment of COVID-19.

GlaxoSmithKline and Vir Biotechnology announced that the European Medicines Agency (EMA) commenced evaluation of VIR-7831 (GSK4182136), an investigational dual-action SARS-CoV-2 monoclonal antibody, for the treatment of adults and adolescents (aged 12 years and older weighing at least 40 kg) with COVID-19 who don’t need oxygen supplementation but are at high risk of developing COVID-19 associated complications.

The study is being carried out by the European Medicines Agency’s (CHMP) Committee for Human Medicinal Products in accordance with Article 5(3) of Regulation 726/2004, which will include EU-wide guidelines for national authorities to make evidence-based decisions on the early use of the drug prior to any formal Marketing Authorization Application. Furthermore, the point of this study will be to reflect analysis of safety and efficacy outcomes from the Phase 3 COMET-ICE (COVID-19 Monoclonal antibody Efficacy Trial – Intent to Care Early) trial, which evaluated VIR-7831 as a monotherapy for the early treatment of COVID-19 in adults at high risk of hospitalization.

The interim study which analysed the results from 583 randomized participants, revealed that participants who received VIR-7831 had an 85 percent (p=0.002) lower risk of hospitalization or mortality than those who received placebo, which was the trial’s primary endpoint.

GSK and Vir continue discussions with global regulators to make VIR-7831 available to patients with COVID-19

As a consequence of this profound effectiveness evidence, the Independent Data Monitoring Committee advised the trial’s recruitment to be halted. Data on the medicine’s efficacy and protection will also be considered by the CHMP. The Australian Therapeutic Goods Administration (TGA), part of the Department of Health, granted this week VIR-7831 a provisional determination. VIR-7831 is the first anti-SARS-CoV-2 monoclonal antibody to receive this classification, which creates a systematic and straightforward process for speeding up the approval of promising new medicines with preliminary clinical results.

VIR-7831 is an investigational compound and has not been granted a marketing authorization anywhere in the world. An Emergency Use Authorization (EUA) application for VIR-7831 has been submitted to the U.S. Food and Drug Administration (FDA).

Preclinical evidence data reveals that VIR-7831 targets a highly conserved epitope of the SARS-CoV-2 spike protein, which may make it more difficult to develop resistance. VIR-7831 retains activity against existing circulating COVID -19 mutations, including the UK, South African, and Brazilian varieties, according to new in vitro evidence from pseudotyped virus assays released online in bioRxiv. VIR-7831 continues to sustain activity against the California form, according to additional preclinical evidence released in bioRxiv. GSK intends to apply for a full Marketing Authorization Application (MAA) to the European Medicines Agency (EMA), which will include the COMET-ICE trial results.

About the COMET-ICE study

The multi-center, double-blind, placebo-controlled COMET-ICE study assessed VIR-7831 in adults with mild or moderate COVID-19 who are at high risk of developing severeCOVID-19. The Phase 2 lead-in portion of the trial, which served as the first-in-human study, evaluated the safety and tolerability of a single 500 mg intravenous (IV) infusion of VIR-7831 or placebo over a 14-day period in 21 non-hospitalized adults enrolled across the United States.

The study started enrolling patients in North America and additional sites in South America and Europe in the global Phase 3 part of the trial in October 2020, based on a favorable assessment of VIR-7831 safety and tolerability evidence from the lead-in part of the trial by an Independent Data Monitoring Committee. An Independent Data Monitoring Committee advised that the COMET-ICE study be suspended for enrollment due to evidence of profound effectiveness in March 2021, but is continuing to follow the study participants for another 24 weeks. When the trial is completed, further information, including epidemiology and virology details, will be published.

The Phase 3 part of the trial assessed the safety and efficacy of a single intravenous infusion of VIR-7831 (500 mg) or placebo in non-hospitalized participants globally. The interim analysis included 291 patients in the treatment arm and 292 patients in the placebo arm. Among those studied, 63% were Hispanic or Latinx and 7% were Black or African American. The primary efficacy endpoint is the proportion of patients who have progression of COVID-19 as defined by the need for hospitalization for at least 24 hours or death within 29 days of randomization.

About the VIR-7831 Clinical Development Program

In addition to the COMET-ICE trial, the full COMET clinical development program for VIR-7831 includes:

  • COMET-PEAK:COMET-PEAK: An ongoing Phase 2 trial with two parts: to compare the safety and viral kinetics of 500 mg intramuscularly (IM) administered VIR-7831 to 500 mg intravenously administered VIR-7831 among low-risk adults with mild to moderate COVID-19 and to evaluate the similarity in pharmacokinetics between VIR-7831 manufactured by different processes.
  • COMET-TAIL: A Phase 3 trial expected to begin in the second quarter of 2021 in high-risk adults to assess whether IM-administered VIR-7831 can reduce hospitalization or death due to COVID-19.
  • COMET-STAR: A Phase 3 trial expected to begin in the second quarter of 2021 in uninfected adults at high risk to determine whether IM-administered VIR-7831 can prevent symptomatic infection.

VIR-7831 is also being evaluated in the outpatient setting in BLAZE-4, a Phase 2 trial sponsored by Eli Lilly and Company, designed to assess the safety and efficacy of Eli Lilly’s bamlanivimab (LY-CoV555) alone and bamlanivimab with other neutralizing antibodies, including VIR-7831, versus placebo in low-risk adults with mild to moderate COVID-19. Topline data announced in March 2021 showed that in combination, the two monoclonal antibodies demonstrated a 70% relative reduction of patients with persistently high viral load at day 7 compared to placebo.

In addition, VIR-7831 and VIR-7832 will be tested in the Phase 1b/2a AGILE study in adults with mild to moderate COVID-19, which is funded by the National Health Service. VIR-7832 is the second monoclonal antibody developed as part of the Vir-GSK partnership to be tested as a COVID-19 treatment. Both VIR-7831 and VIR-7832 are investigational compounds and have not been granted marketing authorizations anywhere in the world.

About the dual-action monoclonal antibody VIR-7831

VIR-7831 (GSK4182136) is an investigational dual-action SARS-CoV-2 monoclonal antibody. Preclinical data reveals it has the potential to both block viral entry into healthy cells and clear infected cells. The antibody binds to an epitope on SARS-CoV-2 that is shared with SARS-CoV-1 (the virus that causes SARS), indicating that the epitope is highly conserved, which may make it more difficult for resistance to develop. VIR-7831, which incorporates Xencor’s Xtend™ technology, also has been designed to achieve high concentration in the lungs to ensure optimal penetration into airway tissues affected by SARS-CoV-2 and to have an extended half-life.

About the dual-action monoclonal antibody VIR-7832

VIR-7832 (GSK4182137) is an investigational dual-action SARS-CoV-2 monoclonal antibody. Preclinical data suggest it has the potential to both block viral entry into healthy cells and an enhanced ability to clear infected cells. The antibody binds to an epitope on SARS-CoV-2 that is shared with SARS-CoV-1 (the virus that causes SARS), indicating that the epitope is highly conserved, which may make it more difficult for resistance to develop. VIR-7832, which incorporates Xencor’s Xtend and other Fc technologies, has been designed to achieve high concentration in the lungs to ensure optimal penetration into airway tissues affected by SARS-CoV-2 and to have an extended half-life. Importantly, VIR-7832 also has been engineered to potentially enhance virus-specific T cell function, which could help treat and/or prevent COVID-19 infection.

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 COVID-19 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.

GSK Commitment to Tackling COVID-19

GSK’s response to COVID-19 has been one of the broadest in the industry, with three potential treatments in addition to the vaccine candidates in development. GSK is collaborating with several organizations on COVID-19 vaccines by providing access to our adjuvant technology.

In addition to the company’s work with Medicago, a collaboration with Sanofi on an adjuvanted protein-based vaccine candidate is now in Phase 2. An earlier stage collaboration with SK Bioscience is also ongoing. SK Bioscience receives funding from CEPI and the Bill and Melinda Gates Foundation to develop differentiated, affordable COVID-19 vaccines for supply globally through the COVAX facility. The use of an adjuvant can be of particular importance in a pandemic since it may reduce the amount of vaccine protein required per dose, allowing more vaccine doses to be produced and contributing to protecting more people.

GSK is also working with mRNA specialist, CureVac, to jointly develop next-generation, multi-valent mRNA vaccines for COVID-19 with the potential to address multiple emerging variants in one vaccine. GSK will also support manufacturing of up to 100m doses of CureVac’s first-generation COVID-19 vaccine.

Furthermore, GSK is committed to exploring potential therapeutic or treatment options for COVID-19 patients. As well as collaborating with Vir Biotechnology to develop existing and identify new anti-viral antibodies that could be used as therapeutic or preventive options for COVID-19 including the dual-action monoclonal antibodies VIR-7831 and VIR-7832, GSK is also assessing whether an investigational monoclonal antibody, otilimab, can help severely ill COVID-19 patients aged over 70 who experience an overreaction of their immune system.

About GSK

GSK is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. For further information please visit www.gsk.com/about-us.

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 COVID-19, hepatitis B virus, influenza A and human immunodeficiency virus. For more information, please visit www.vir.bio.


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