The US Government’s Biomedical Advanced Research and Development Authority (BARDA) has made an initial investment of approximately $55 million for rapid development of VIR-2482, the Vir Biotechnology’s investigational prophylactic monoclonal antibody (mAb) for seasonal and pandemic influenza viruses.
Its purpose being to support pandemic preparedness for influenza and other infectious disease threats, this is the first award from BARDA – part of the US Department of Health and Human Services’ (HHS) Administration for Strategic Preparedness and Response (ASPR) – for pre-exposure prophylaxis for influenza.
VIR-2482 is an investigational intramuscularly administered influenza A-neutralising mAb. It has been shown in vitro to cover all major influenza A strains that have arisen since the 1918 ‘Spanish flu’ pandemic and is designed as a universal prophylactic for influenza A.
Furthermore, VIR-2482 could have the potential to overcome the limitations of current flu vaccines and result in higher levels of protection, given it does not rely on an individual to create their own protective antibody response. Additionally, the incorporated Xencor Xtend Technology is half-life engineered, meaning a single dose could potentially last an entire flu season.
Seasonal influenza (or flu) is a highly contagious respiratory disease that can cause severe illness and life-threatening complications. In just the past few years, seasonal influenza has resulted in around 4 million hospitalisations and circa 500,000 global annual deaths.
Pandemic influenza, by contrast, is a contagious airborne respiratory disease with unpredictable timing and severity and against which humans have little or no immunity. Four such pandemic influenzas have occurred in only the past century, with the 1918 ‘Spanish flu’ alone having resulted in 50 million deaths worldwide.
Given the past two years’ and ongoing experience with SARS-CoV-2 and its variants, the BARDA multi-year contract – potentially an investment of up to $1 billion in total – aims to continue the Authority’s efforts in preparing for and responding to public health emergencies. Currently, there is a significant unmet need to address shortcomings in preventative and therapeutic options for influenza, the efficacy of the present options that do exist ranging from only 10% to 60%.
Therefore, this initial $55 million investment aims to address these shortcomings. It includes for a phase 2 pre-exposure prophylaxis trial, to begin this second half of the year, with initial data expected by mid-2023. The balance of the award is subject to up to 12 options being exercised by BARDA in further support of the development of pre-exposure prophylactic antibodies, including and beyond VIR-2482.
This extended area, beyond prevention of influenza illness, will potentially be for supportive medical countermeasures for up to 10 “other pathogens of pandemic potential”, whether they be “chemical, biological, radiological [or] nuclear”.
Dr Rajesh Gupta, vice president, global health portfolio and public-private partnerships at Vir Biotechnology, said: “COVID-19 reinforced the ever-present global threat of infectious diseases, and the critical need for readily available solutions in advance of the next pandemic.”
A commercial-stage immunology company, Vir Biotechnology’s current development pipeline includes product candidates targeting hepatitis B and hepatitis D viruses and human immunodeficiency virus, in addition to influenza A and COVID-19, the latter of which Vir (together with GSK) previously delivered the antibody sotrovimab (Xevudy) for. The company also co-discovered ansuvimab-zykl for addressing the Ebola crisis.
Bolyn Hubby, PhD, executive vice president and chief corporate affairs officer at Vir Biotechnology, said: “Just as the COVID-19 pandemic required unprecedented cross-sector collaboration around the globe, tackling the outbreaks and pandemics of tomorrow will require an ‘all hands on deck’ approach that unites a broad array of public and private organisations.”
Under a collaboration agreement signed with GlaxoSmithKline (GSK) in 2021, GSK holds an exclusive option to lead post-phase 2 development and commercialisation of VIR-2482.
