GSK, VIR Expand Agreement to Develop Novel Therapies for Influenza

GSK and Vir Biotechnology recently signed an agreement to expand their existing collaboration to include the research and development of new novel therapies for influenza and other respiratory viruses.

Under the agreement expansion, GSK will have exclusive rights to collaborate with Vir Biotechnology on the development of potential best-in-class monoclonal antibodies to combat various diseases.  

One of the antibodies, VIR-2482, is an intramuscularly administered investigational monoclonal antibody designed for influenza A. The antibody has already completed a Phase 1 trial and next-generation antibodies for the prevention or treatment of influenza during a three-year research period, GSK noted.

“We believe, now more than ever, that it is very important to develop new therapies to treat and ideally prevent infectious diseases,” Hal Barron, chief scientific officer and president of research and development at GSK said in the announcement.

“I am delighted that we are expanding our collaboration with Vir whose focus on novel antibodies, expertise in functional genomics, unique technology and talented scientists will further strengthen GSK’s position as a world leader in infectious diseases,” Barron continued. 

GSK will have the option to co-develop VIR-2482 after Vir Biotechnology completes and reports Phase 2 trial outcomes. The company will share development updates of all other influenza monoclonal antibodies as well. 

Additionally, the companies will engage in two additional research programs. 

First, the pair will expand their current functional genomics collaboration to develop potential pan-coronavirus therapeutics to include other respiratory virus agents.

Second, GSK and Vir Biotechnology will collaborate on and develop up to three neutralizing monoclonal antibodies identified using Vir Biotechnology’s antibody platform. This initiative allows the companies to target non-influenza pathogens during a three-year research period.  

“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,” said George Scangos, PhD, CEO of Vir Biotechnology.

Under the terms of agreement, GSK will make an upfront payment of $225 million and a further equity investment in Vir Biotechnology of $120 million.

Initially, Vir Biotechnology will fund the development of VIR-2482 through completion of Phase 2 trials. 

Although the companies will share development costs and related profits of the agreement expansion, GSK will pay Vir Biotechnology nearly $200 million based on the successful delivery of pre-defined regulatory milestones, the company explained. 

GSK and Vir Biotechnology’s expansion builds on the agreement signed in April 2020 to enhance COVID-19 drug discovery through the use of CRISPR and artificial intelligence. Initially, the partnership focused on accelerating the development of specific antibody candidates using Vir’s monoclonal antibody platform technology and GSK’s expertise in functional genomics. 

Two promising antibody candidates, VIR-7831 and VIR-7832, previously demonstrated potential to both block viral entry into healthy cells and clear infected cells. The antibody also elicited a high barrier to resistance.

At the beginning of October, the companies announced the global expansion of a Phase 3 study evaluating VIR-7831. The study will evaluate VIR-7831 in patients who are at high risk of hospitalization from the coronavirus. 

The antibody was selected based on study data that showed the antibody can neutralize the virus, kill infected cells, provide a high barrier to resistance, and achieve high concentrations in the lungs.

Then in mid-January, the companies entered into an agreement with UK-based AGILE initiative to evaluate VIR-7832 in a Phase 1b/2a clinical trial. 

The AGILE trial platform will use adaptable protocols and statistical models to evaluate VIR-7832 in patients with mild to moderate COVID-19. The trial will begin in the first quarter of this year.