– Approximately $50 million in new investment Biomedical Advanced Research and Development Authority Includes $40 million in NextGen project funding –
– Contract expands existing support for development of drug candidates to prevent and treat pandemic pathogens –
SAN FRANCISCO, Oct. 3, 2023 (GLOBE NEWSWIRE) — Vir Biotechnology, Inc. (Nasdaq: VIR) today announced that the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services ) HHS) Administration for Strategic Preparedness and Response (ASPR) has awarded approximately $50 million in new funding to Vir to advance the development of novel monoclonal antibody (mAb) drug candidates and provide solutions to expand the use of mAbs in COVID-19 and Applicability and response in pandemic preparedness.
Marianne De Backer said: “We are honored to continue working with the U.S. government to leverage our world-class antibody platform with the hope of developing powerful new medicines to protect our communities against global infectious disease threats, including pathogens with pandemic potential. ”, Master, PhD, MBA, CEO of Vir. “We are grateful for the U.S. government’s continued support of our innovative technological approach to mAb development as we seek to optimize mAb delivery. “We look forward to starting with VIR-7229, a next-generation COVID-19 mAb, preclinical Research has demonstrated its high efficacy against historical and currently prevalent variants and has the potential to be the best in its class. “
The new funding will support research and development of novel alternative mAb delivery technologies that have the potential to revolutionize mAb delivery technology by increasing expression relative to existing technologies. This delivery can expand the range of management options and shorten development and manufacturing time.
$40 million of total funding is part of Project NextGen, an initiative launched by HHS to advance a pipeline of new and innovative vaccines and treatments for COVID-19, and will support VIR-7229 in the context of Phase 1 development. Developing alternative monoclonal antibody delivery technologies. Phase 1 trials are expected to be completed in the second half of 2025. $10 million of the total funding is supported by BARDA’s Chemical, Biological, Radiological, and Nuclear (CBRN) Medical Countermeasures Division, which will support new discoveries targeting a second class of therapeutics with large potential in the context of further advancing alternative monoclonal antibody delivery technologies. Monoclonal antibodies against pathogens of epidemic potential.
The new investment falls within Vir’s existing Other Transaction Authority (OTA), a multi-year BARDA contract awarded to Vir in 2022. The OTA has a potential total investment of up to $1 billion to support Vir’s development of future pandemic influenza monoclonal antibodies and the potential development of up to 10 emerging infectious disease or CBRN medical countermeasure candidates. The balance of potential funding is subject to BARDA exercising up to 12 options to further support the development of pre-exposure prophylactic antibodies to prevent influenza illness or to support medical countermeasures against other pathogens with pandemic potential.
Vir also received approximately $11 million in additional BARDA funding, which will be used to conclude activities in the BARDA-supported Phase 2 PENINSULA trial evaluating the investigational prophylactic monoclonal antibody VIR-2482 to prevent symptomatic influenza A The role of disease.
These programs are funded in whole or in part by federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response (ASPR); Biomedical Advanced Research and Development Authority (BARDA), OT Number: 75A50122C00081.
About VIR-7229
VIR-7229 is a potent preclinical monoclonal antibody that has demonstrated the ability to broadly neutralize COVID-19 variants in vitro. VIR-7229 was designed as a preventive agent against COVID-19 and was characterized using Vir’s proprietary mAb discovery platform. VIR-7229 incorporates Xencor, Inc.’s Xtend™️ technology and is affinity matured using machine learning to improve its effectiveness in binding to SARS-CoV and SARS-CoV-2 variants.
About VIR-2482
VIR-2482 is an investigational hemagglutinin-targeted, intramuscular influenza A-neutralizing monoclonal antibody. In vitro, it has been shown to cover all major influenza A strains that have emerged since the 1918 influenza pandemic. VIR-2482 is designed as an influenza A prophylactic agent. VIR-2482 incorporates Xencor’s Xtend™ and was characterized using Vir’s proprietary mAb discovery platform.
About Vir Biotechnology
Vir Biotechnology, Inc. is an immunology company focused on combining cutting-edge technologies to treat and prevent infectious diseases and other serious diseases. Vir has assembled two technology platforms designed to stimulate and enhance the immune system by leveraging key observations of natural immune processes. Its current clinical development pipeline includes product candidates targeting hepatitis B and D viruses, influenza A and B, human immunodeficiency virus and COVID-19. Vir is developing multiple preclinical drug candidates, including candidates targeting RSV/MPV and HPV. Vir frequently posts information on its website that may be important to investors.
forward-looking statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “may,” “will,” “plan,” “potential,” “goal,” “expect,” “anticipate,” “hopefully” and similar expressions (as well as references to future events, conditions or (other words or expressions of circumstance) are intended to identify forward-looking statements. These forward-looking statements are based on Vir’s expectations and assumptions as of the date of this press release. Forward-looking statements contained in this press release include, but are not limited to, statements regarding Vir’s strategy and Statement of plan; Potential advantages of VIR-7229 in preventing historically and currently circulating COVID-19 variants, and potential advantages of alternative mAb delivery technologies in pandemic preparedness and response; Tapering VIR-2482 to prevent influenza A Activity in symptomatic disease; the potential benefits, safety and effectiveness of Vir’s investigational therapies; the risks and uncertainties associated with drug development and commercialization Many important factors could cause differences between current expectations and actual results, including whether Uncertainty in realizing the expected benefits of the BARDA collaboration; Unexpected safety or efficacy data or results observed during clinical trials or data readout; The timing and outcome of Vir’s planned interactions with regulatory agencies; Difficulty in obtaining regulatory approval; Uncertainty about whether Vir will be able to realize expected benefits from collaborating with other companies; Difficulties in collaborating with other companies; Challenges in acquiring manufacturing capacity; Lower-than-expected rates of clinical site activation or clinical trial enrollment; Success of Vir’s competitors in developing and or commercialization of alternative product candidates; changes in anticipated or existing competition; delays or interruptions in Vir operations or clinical trials, geopolitical changes or other external factors; and unexpected litigation or other disputes. Drug development and commercialization involve a high degree of risk , only a small number of research and development projects lead to commercialization of products. Results from early-stage clinical trials may not represent the full range of results or results from later-stage or larger clinical trials, and do not ensure regulatory approval. You should not place undue reliance on these statements or scientific data presented. Additional factors that could cause actual results to differ from those expressed or implied by the forward-looking statements in this press release are discussed in Vir’s filings with the Securities and Exchange Commission, including those under the heading “Risk Factors” ” section. Except as required by law, Vir disclaims any obligation to update any forward-looking statements contained herein to reflect changes in expectations, even if new information becomes available.
