Publicly traded Vir Biotechnology (Nasdaq: VIR) and GlaxoSmithKline plc (LSE/NYSE: GSK) announced the first patient was dosed in a Phase 2/3 clinical trial evaluating VIR-7831 (GSK4182136), a fully human anti-SARS-COV-2 monoclonal antibody for the early treatment of COVID-19 in patients who are at high risk of hospitalization. Now this pair compete against Eli Lilly and Regeneron, front runners in the COVID-19 antibody race.
A key feature of SARS-CoV-2 is the spike protein that covers the virus’ outer surface. The virus uses these spike proteins to bind to and enter human cells, leading to infection. It is hypothesized that monoclonal antibodies directed against the spike proteins could represent a therapeutic approach against COVID-19. Pre-clinical studies with VIR-7831, which was identified through Vir’s antibody platform, showed affinity for the SARS-CoV-2 spike protein and high potency in neutralizing SARS-CoV-2, suggesting a high barrier to resistance and an ability to recruit immune cells to kill already infected cells. In addition, VIR-7831 has been designed to enhance lung bioavailability.
The Vir Biotechnology Product
Monoclonal antibodies that neutralize SARS-CoV-2 infection, the virus that causes COVID-19, are being investigated as a potential therapeutic and prophylactic approach against the disease. They are produced, or cloned, from immune cells in a laboratory. Vir’s antibody platform has identified unique antibodies from survivors that may work by blocking the virus from infecting new cells (neutralization) and by recruiting the immune system to eliminate infected cells (effector function).
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 for escape mutants to develop. VIR-7832 has been engineered to enhance lung bioavailability, have an extended half-life, and potentially function as a therapeutic and/or prophylactic T cell vaccine.
GSK & Vir
VIR-7831 (GSK4182136) 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 for escape mutants to develop. VIR-7831/GSK4182136 has been engineered to enhance lung bioavailability and have an extended half-life.
The COMET-ICE Trial
Known as the COVID-19 Monoclonal antibody Efficacy Trial—Intent to Care Early or COMET-ICE, this study is designed to enroll approximately 1,300 patients worldwide who have early symptomatic infection. The study team seeks to assess whether VIR-7831, as a single-dose monoclonal antibody, can prevent hospitalization due to COVID-19. Initial results may be available before the end of the year, with complete results due during the first quarter of 2021. The sponsors position that if the study results go well possible commercialization milestones could be met in the first half of 2021.
The study initiation was preceded by the two companies inking a collaboration deal back in April 2020.
The COMET-ICE multi-center, double-blind, placebo-controlled Phase 2/3 study investigating VIR-7831 in patients with mild or moderate COVID-19 who are at high risk of progression to severe disease comprises two parts. The first part (the Lead-In phase) will serve as the first-in-human assessment. The Lead-In phase will assess the safety and tolerability of a single 500 mg intravenous (IV) infusion of VIR-7831 or placebo over a 14-day period in non-hospitalized patients. It aims to recruit 20 patients across the United States. Following this initial safety assessment, the second part (the Expansion phase) will progress with the aim of reducing the need for hospitalization. The Expansion phase will assess the safety and efficacy of a single IV infusion of VIR-7831 or placebo in approximately 1,300 non-hospitalized participants globally. The primary efficacy endpoint is the proportion of patients with mild or moderate COVID-19 who worsen, as defined by the need for hospitalization or death, within 29 days of randomization.
Additional Studies Planned
The COMET clinical development program for VIR-7831 also includes two additional planned trials—one for the treatment of severely ill hospitalized patients and another for the prophylaxis of symptomatic infection.
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.
The Vir Biotechnology & GSK Deal
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 as well as identify new antiviral 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.