VIR-2482 Monoclonal Antibody Description
Vir Biotechnology VIR-2482 is an investigational intramuscularly administered influenza A-neutralizing monoclonal antibody. This monoclonal antibody (mAB) is designed to protect against seasonal and pandemic influenza.
VIR-2482 is designed as a universal prophylactic for influenza A. In vitro, VIR-2482 has been shown to protect all significant strains of influenza A. Due to its broad strain coverage of diseases, it has the potential to overcome the limitations of current influenza vaccines and lead to meaningfully higher levels of protection due to its broad strain coverage and because it does not rely on individuals to create their protective antibody response.
VIR-2482, which incorporates Xencor's Xtend™ Technology, has also been half-life engineered so that a single dose can last the flu season. Under the collaboration agreement signed with GlaxoSmithKline (GSK) in 2021. GSK has an exclusive option to lead the post-Phase 2 development and commercialization of VIR-2482.
VIR-2482 is partly funded with federal funds from the Administration for Strategic Preparedness and Response, Biomedical Advanced Research and Development Authority (BARDA), under Other Transaction Number: 75A50122C00081. BARDA's initial investment of approximately $55 million will support the Phase 2 PENINSULA trial. In addition, the multi-year contract also allows for a potential total investment of up to $1 billion for the clinical development of additional future pandemic influenza monoclonal antibodies, as well as the possible development of up to 10 emerging infectious disease or Chemical, Biological, Radiological, and Nuclear medical countermeasure candidates.
VIR-2482 has completed a Phase 1 clinical trial and launched a phase 2 study.
Vir Biotechnology is a commercial-stage immunology company located in San Francisco, CA, focused on combining immunologic insights with cutting-edge technologies to treat and prevent serious infectious diseases.
VIR-2481 is currently being developed to prevent influenza A viruses and pandemic influenza.
Seasonal influenza is a highly contagious respiratory disease that can cause severe illness and life-threatening complications. Pandemic influenza is an infectious airborne respiratory disease that is unpredictable in timing and severity and for which humans have little or no immunity. Four influenza pandemics have occurred over the past century, the most severe being the 1918 "Spanish flu," which is estimated to have caused up to 50 million deaths worldwide.
December 21, 2022 - Vir Biotechnology has enrolled approximately 3,000 participants in their Phase 2 PENINSULA (PrevEntioN of IllNesS DUe to InfLuenza A) trial.
October 18, 2022 - Vir Biotechnology, Inc. announced that the first participant had been dosed in the Phase 2 PENINSULA trial evaluating VIR-2482 for preventing illness due to influenza A.
October 4, 2022 - The U.S. Government's Biomedical Advanced Research and Development Authority announced an initial investment of $55 million for the ongoing and rapid development of VIR-2482. The multi-year contract has the potential for up to $1 billion to advance the development of a full portfolio of innovative solutions to address influenza and potentially other infectious disease threats.
February 17, 2021 - GlaxoSmithKline plc and Vir Biotechnology, Inc. announced they have signed a binding agreement to expand their existing collaboration to include the research and development of new therapies for influenza and other respiratory viruses.
December 31, 2022 - the U.S. NIH published: VIR-2482: A potent and broadly neutralizing antibody for preventing influenza A illness.
March 25, 2020 - Xencor, Inc. announced it has entered into a technology license agreement with Vir Biotechnology, Inc., in which Vir will have non-exclusive access to Xencor's Xtend™ Fc technology to extend the half-life of novel antibodies that Vir is investigating as potential treatments for patients with COVID-19, the disease caused by the novel coronavirus SARS-CoV-2.
VIR-2482 Clinical Trials
VIR-2482 has been studied in a phase 1 clinical trial. A phase 2 pre-exposure clinical trial began in October 2022. The primary efficacy endpoint is the proportion of trial participants with protocol-defined influenza-like illness with confirmed influenza A infection compared to placebo. Other endpoints will evaluate the effect of VIR-2482 on the severity and duration of illness in trial participants with confirmed influenza A compared to placebo. Initial data are expected in mid-2023.