Vir Biotechnology Inc. has won a multi-year agreement with the U.S. government to support pandemic preparedness for influenza and other infectious disease threats, the company announced in a press release on Tuesday. Vir is a member of the Biotechnology Innovation Organization (BIO).
The Biomedical Advanced Research and Development Authority’s (BARDA) contract with Vir is the first award from the agency’s solicitation for contracts for developing influenza pre-exposure prophylaxis. The contract has “the potential for up to $1 billion to advance the development of a full portfolio of innovative solutions.”
BARDA is part of the U.S. Department of Health and Human Services (HHS) Administration for Strategic Preparedness and Response (ASPR).
The company said the initial investment of $55 million will support the ongoing development of Vir’s investigational monoclonal antibody (mAb),” an investigational prophylactic monoclonal antibody designed to protect against seasonal and pandemic influenza.”
“This includes a Phase 2 pre-exposure prophylaxis trial expected to begin in the second half of 2022 with initial data anticipated in mid-2023,” Vir Biotechnology said.
The agreement outlines “potential support for Vir’s clinical development of additional future pandemic influenza mAbs,” and “of up to 10 emerging infectious disease or Chemical, Biological, Radiological, and Nuclear medical countermeasure candidates.”
It will also allow for a potential total investment of up to $1 billion, “subject to BARDA exercising up to 12 options in further support of the development of pre-exposure prophylactic antibodies including and beyond VIR-2482 for the prevention of influenza illness or possibly supporting medical countermeasures for other pathogens of pandemic potential.”
“We now look forward to applying our scientific and executional expertise to this BARDA collaboration focused on advancing innovative solutions to influenza, as well as other infectious diseases with future pandemic potential,” said Rajesh Gupta, vice president, global health portfolio and public-private partnerships at Vir Biotechnology.
An upgrade from current flu vaccines?
VIR-2482 is an investigational intramuscularly administered mAb that “in vitro, it has been shown to cover all major strains” of the virus that have arisen since the 1918 Spanish flu pandemic.
Designed as a universal prophylactic for Influenza A – the only influenza virus known to cause pandemics – VIR-2482 is engineered so a single dose has the potential to offer protection for the entire flu season.
Due to its broad strain coverage and “because it does not rely on an individual to create their own protective antibody response,” Vir expects VIR-2482 “has the potential to overcome the limitations of current flu vaccines and lead to meaningfully higher levels of protection.” It’ll mainly “target people who don’t produce an adequate immune response, such as those aged 65 and over.”
According to CDC estimates, “influenza was associated with 8 to 13 million illnesses, 3,7 to 6,1 million medical visits, 82,000- 17.000 hospitalizations, and 5,000 -14.000 deaths” in the United States during the 2021-2022 influenza season.