Vir Biotechnology, Inc. - VIR STOCK NEWS

Vir Biotechnology and GSK announced progress in discussions with global regulators for VIR-7831, a monoclonal antibody for treating COVID-19. The European Medicines Agency (EMA) has commenced a review, using interim data from the Phase 3 COMET-ICE trial, which showed an 85% reduction in hospitalization or death. VIR-7831 received a provisional determination from Australia’s TGA, the first for an anti-SARS-CoV-2 monoclonal antibody. An Emergency Use Authorization application is pending with the FDA.

Vir Biotechnology, Inc. (Nasdaq: VIR) published new preclinical research demonstrating how SARS-CoV-2 enters host cells and how auxiliary receptors may impact monoclonal antibodies (mAbs) efficacy. The study identifies three auxiliary receptors that enhance infection, with SIGLEC1 being notably important in severe COVID-19 cases. The research reveals that non-RBM-targeting antibodies, such as VIR-7831 and VIR-7832, show enhanced neutralizing activity compared to RBM-targeting antibodies. These findings support the potential of these investigational mAbs in treating and preventing COVID-19.

Vir Biotechnology announced that CEO George Scangos, Ph.D., will engage in a virtual fireside chat at the 20th Annual Needham Virtual Healthcare Conference on April 13, 2021, at 8:45 am PT / 11:45 am ET. The session will be accessible via live webcast in the Investors section of the Vir website, with an archived version available for 30 days post-event. Vir Biotechnology focuses on treating serious infectious diseases using advanced immunologic technologies, with ongoing projects targeting COVID-19, hepatitis B, influenza A, and HIV.

Vir Biotechnology announced promising results for VIR-7831, an investigational monoclonal antibody targeting SARS-CoV-2. New preclinical data show VIR-7831 maintains its neutralizing activity against the L452R mutation found in the California variant. While the California variant reduces the neutralization potency of plasma from vaccinated individuals, VIR-7831 remains effective, highlighting its potential to combat current and future variants. The company aims to expedite VIR-7831's availability for patients amidst rising variant concerns.

Eli Lilly, Vir Biotechnology, and GlaxoSmithKline announced encouraging results from the Phase 2 BLAZE-4 trial, demonstrating a 70% reduction in high viral load for COVID-19 patients treated with bamlanivimab and VIR-7831 compared to placebo. The trial met its primary endpoint with a p-value of <0.001. No COVID-19 related hospitalizations or deaths occurred by day 29 in either treatment arm. Despite these promising data, both drugs are investigational and not yet FDA-approved. Discussions with regulatory bodies are ongoing to expedite availability.

Eli Lilly, Vir Biotechnology, and GlaxoSmithKline announced promising topline results from the Phase 2 BLAZE-4 trial, showing that the combination of bamlanivimab and VIR-7831 significantly reduced high viral loads in low-risk COVID-19 patients by 70% at day 7 compared to placebo. No related hospitalizations or deaths occurred by day 29. Preclinical data suggest the combination can combat resistant SARS-CoV-2 variants. An Emergency Use Authorization application for VIR-7831 has been submitted to the FDA, aiming to expedite its availability for COVID-19 treatment.

Vir Biotechnology and GlaxoSmithKline have applied for Emergency Use Authorization (EUA) from the FDA for VIR-7831, a dual-action monoclonal antibody for adults and adolescents with mild-to-moderate COVID-19 at risk for hospitalization. The application is supported by interim data from the Phase 3 COMET-ICE trial, showing an 85% reduction in hospitalization or death compared to placebo. An Independent Data Monitoring Committee halted further enrollment due to significant efficacy. The companies are also pursuing regulatory discussions in Europe for broader access to this treatment.

Vir Biotechnology and GSK announced that the Independent Data Monitoring Committee recommended stopping the Phase 3 COMET-ICE trial early due to an impressive 85% reduction in hospitalization or death for patients receiving VIR-7831 compared to placebo. Following this, they plan to seek Emergency Use Authorization in the U.S. and other countries. Additionally, in vitro studies show that VIR-7831 retains effectiveness against major COVID-19 variants. The trial involved 583 patients, with ongoing follow-up to gather more data on safety and efficacy.

Vir Biotechnology and GlaxoSmithKline announced an update on their COVID-19 treatment, VIR-7831, during the NIH's ACTIV-3 trial. Although VIR-7831 initially met criteria to advance, concerns regarding its efficacy led to a recommendation to close its enrollment. The Data and Safety Monitoring Board found no safety issues but noted uncertainties about patient benefit. The companies aim to further evaluate VIR-7831's potential while upcoming data from the COMET-ICE trial is anticipated. VIR-7831 is designed to block viral entry and clear infected cells, potentially effective against emerging variants.