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Vir Biotechnology, Inc. and GlaxoSmithKline plc are taking VIR-7831 (GSK4182136) – an antibody therapy against SARS-CoV-2 – into Phase III testing based on safety results from the Phase II lead-in to the Phase II/III COMET-ICE clinical trial. Initial data from the registrational Phase III portion of the trial seeking to prevent hospitalization of COVID-19 patients may be available before the end of 2020 with complete results expected in January 2021, the companies said on 6 October.

Vir chief medical officer Phil Pang told Scrip that the COMET-ICE independent data monitoring committee reviewed safety data from 20 US patients – 10 who were treated with VIR-7831 and 10 who received a placebo – and found that the results justified moving into Phase III. The registrational phase of the study will enroll more than 1,300 patients in North America, South America and Europe with about 670 people each in the VIR-7831 and placebo arms of the trial.

COMET-ICE is enrolling patients at high risk of hospitalization – adults age 55 and older as well as adults age 18 and older with asthma, cardiovascular, pulmonary or renal diseases that put them at risk of more severe COVID-19 infection. The primary efficacy endpoint is the proportion of patients who progress to hospitalization or who die within 29 days of randomization in the study. Participants will receive a single intravenous infusion of VIR-7831 or placebo.

Study Designed To Provide Fast, Clear Results

Pang explained that Vir looked closely at epidemiological data from the Center for Disease Control and Prevention (CDC) to determine the best population for initial testing of VIR-7831 that would give the clearest evidence of efficacy. 

In contrast, he noted, Regeneron Pharmaceuticals, Inc. tested its antibody cocktail REGN-COV2 in more of an all-comers population and few patients progressed to hospitalization across all three groups of patients treated in an ongoing Phase I/II/III study. (Also see "Regeneron’s COVID-19 Antibody Cocktail Shows Early Promise, But Does It Merit An EUA?" - Scrip, 30 Sep, 2020.) Eli Lilly and Company and partner AbCellera Biologics Inc. also saw small numbers of hospitalized patients in early Phase II results for LYCoV555, their antibody against SARS-CoV-2. (Also see "Lilly Claims Proof Of Concept For Neutralizing Antibodies In COVID-19 Therapy" - Scrip, 16 Sep, 2020.)

Regeneron may pursue an emergency use authorization (EUA) from the US Food and Drug Administration for REGN-COV2 based its initial data, and Pang said Vir and GSK haven’t ruled out pursuing an EUA if the initial safety and efficacy results from COMET-ICE later this year are “profound.” However, he noted, the Phase II/III trial was designed to be the first and only study needed to pursue registration and full approval of VIR-7831 in non-hospitalized COVID-19 patients.

Vir and GSK plan to begin a study in the treatment of hospitalized patients in October and a prophylaxis study in the prevention of COVID-19 in people who haven’t been infected with SARS-CoV-2 in December or January. A follow-on antibody therapeutic, VIR-3872, is expected to move into its first study in COVID-19 patients before the end of 2020. With enhanced effector function, VIR-3872 is engineered to work as a therapeutic antibody and as a T-cell vaccine, so it will be tested for COVID-19 prevention as well.

Both antibodies are based on S309, a neutralizing antibody that targets the SARS-CoV-2 receptor binding domain. S309 was isolated from a patient who recovered from severe acute respiratory syndrome (SARS) in 2003 and it has been effective against SARS-CoV-2 in cells and animal models. VIR-7831 was selected for clinical development based on its potential to neutralize the novel coronavirus, kill infected cells, provide a high barrier to resistance and achieve high concentrations in the lungs.

Vir/GSK Antibody Programs Well-Funded

Vir and GSK have been working together since April to develop antibody therapies against SARS viruses and the companies initiated COMET-ICE in late August to test the first program under their partnership. GSK made an initial $250m equity investment in Vir to help the firm rapidly advance VIR-7831 and VIR-7832. Vir has multiple therapeutic and prophylactic antibody candidates in development against the novel coronavirus and other infectious diseases, including hepatitis B and influenza. 

Vir CEO George Scangos has been an advocate for partnering to bring COVID-19 therapeutics and vaccines to patients rapidly and has been working with the Biotechnology Innovation Organization around BIO’s efforts to facilitate such collaborations. GSK and Vir first agreed to partner in April to keep VIR-7831 and VIR-7832 moving forward rapidly and finalized the terms of their agreement in June while that work was under way, Vir noted in its second quarter earnings report. (Also see "Vir Advances Antibodies Against COVID-19, CEO Scangos Leads BIO’s Coronavirus Outreach" - Scrip, 20 Mar, 2020.)

Between its fundraising and partnering activities, the company had $552.4m in cash at the end of June. Vir raised more than $300m in additional cash through a follow-on public offering in July. (Also see "Finance Watch: Poseida, Nkarta And Inventiva Are July’s First Biopharma IPOs" - Scrip, 10 Jul, 2020.) 

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