The 2020 agreement focused on using Vir Biotechnology’s monoclonal antibody platform technology to identify new and existing anti-viral antibodies against COVID-19, with GSK making a $250m investment in Vir. Two antibodies (VIR-7831 and VIR-7832) are now in clinical trials.
The expanded collaboration provides GSK with exclusive rights to collaborate with Vir on the development of monoclonal antibodies for the prevention or treatment of influenza. GSK will increase its equity investment in Vir by $120m and make an upfront payment of $225m, with the potential for a further $200m milestone payments. It also gains the option to develop monoclonal antibody VIR-2382 past Phase 2 trials: in which case it will pay a fee of $300m.
Influenza A-neutralizing monoclonal antibody
The expanded collaboration includes VIR-2482: an investigational intramuscularly administered influenza A-neutralizing monoclonal antibody. In vitro, VIR-2482 has been shown to cover all major strains of influenza A that have arisen since the 1918 Spanish flu pandemic.
VIR-2482 is designed as a universal prophylactic for influenza A. GSK and Vir see its potential to overcome the limitations of current flu vaccines and lead to higher levels of protection thanks to its broad strain coverage, and because it does not rely on an individual to create their own protective antibody response. VIR-2482 has been half-life engineered so that a single dose has the potential to last the entire flu season.
Vir will continue to fund the development of VIR-2382 for the time being: with GSK getting the exclusive option to co-develop VIR-2482 after Vir completes and reports Phase 2 trial outcomes. If GSK exercises its option, it will pay a fee of $300m.
The agreement will also include a three-year research period where GSK and Vir will explore next generation antibodies for the prevention or treatment of influenza. GSK and Vir will share development costs and profits on these programs.
Influenza causes up to 500,000 hospitalisations and 34,000 deaths each year in the US alone, with around 75% of these caused by Influenza A.
Vir's antibody tech
Vir’s antibody platform seeks to capitalise on unusually successful immune responses in certain people to infectious diseases.
The platform is used to identify rare antibodies from recovered patients that have the potential to treat and prevent rapidly evolving pathogens via direct pathogen neutralization and immune system stimulation.
Vir engineers the fully human antibodies that it discovers to enhance their therapeutic potential.
Its platform has been used to identify and develop antibodies for pathogens including SARS-CoV-2, hepatitis B virus, influenza A, Ebola (mAb114, approved for use in the US as Ebanga), malaria, and others.
The first antibody under the 2020 GSK/Vir partnership, VIR-7831, is currently being investigated in two global phase 3 studies; for the early treatment of COVID-19 in patients who are at high risk of hospitalisation, and for the treatment of hospitalised patients with COVID-19.
The companies will investigate a second antibody, VIR-7832, in the early treatment of COVID-19 in a Phase 1b/2a trial starting in the first quarter of this year.
Other respiratory targets
Two additional research programmes outside of influenza will also be included in the expanded GSK-Vir collaboration.
The first will expand their current functional genomics program – which is developing potential pan-coronavirus therapeutics - to now include other respiratory virus targets.
Another program will see the companies collaborate to develop up to three neutralising monoclonal antibodies, identified using Vir’s antibody technology platform, to target non-influenza pathogens during a three-year research period.
George Scangos, Ph.D., CEO, Vir Biotechnology, said: “As part of our functional genomics collaboration directed at COVID-19, we have turned up multiple targets that have the potential to treat influenza and other respiratory viruses, and it makes sense to extend the scope of our collaboration to include these new targets.
“This expanded collaboration supports the rapid advancement of multiple promising investigational compounds in our pipeline, increasing the likelihood that these potential life-saving treatments will reach patients sooner, and will advance our shared goal of developing single drugs that can address multiple ‘bugs.’”