GlaxoSmithKline will have the exclusive option to co-develop VIR-2482 after Vir Biotechnology completes and reports the Phase 2 trial outcomes. GSK will share development costs on the development of all other influenza mAbs.

Influenza

Influenza causes around 500,000 hospitalizations and 34,000 deaths each year in the United States alone. Around 75% of which are caused by influenza A. The protection provided by current vaccines varies from season to season based on the virus strains circulating. People over 65 years of age with at least one comorbidity such as cardiovascular disease, diabetes or those who are immunocompromised, are at a significantly increased risk of flu and flu-related hospitalization and mortality. This is also a population where the currently available vaccines have historically had lower efficacy.

As part of the new collaboration agreement the companies will also engage in two additional research programs:

The first program:

Expanding their current functional genomics collaboration to develop potential pan-coronavirus therapeutics to now include other respiratory virus targets.

The second program:

The firms will collaborate to develop up to three neutralizing monoclonal antibodies identified using Vir’s antibody technology platform to target non-influenza pathogens during a three-year research period. 

From Vir Biotechnology and GlaxoSmithKline

George Scangos, Ph.D., CEO, Vir Biotechnology, said: “GSK has been a valuable strategic partner and scientific collaborator in the fight against COVID-19. 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 potentially life-saving treatments will reach patients sooner, and will advance our shared goal of developing single drugs that can address multiple ‘bugs.’”

Dr. Hal Barron, Chief Scientific Officer and President R&D, GlaxoSmithKline, said: “We believe, now more than ever, that it is very important to develop new therapies to treat and ideally prevent infectious diseases. 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.”

Under the terms of the agreement:

GlaxoSmithKline will make an upfront payment of $225 million and a further equity investment in Vir Biotechnology of $120 million. Initially, Vir will continue to fund the development of VIR-2482 through the completion of Phase 2 trials, after which time, if GSK exercises its option to co-develop VIR-2482, it will pay an option fee of $300 million.

Following option exercise for VIR-2482, and for each other program in the expanded collaboration, the companies will share the development costs and related profits associated with this agreement. GSK will also pay Vir up to $200 million based on the successful delivery of pre-defined regulatory milestones. The equity investment and collaboration agreement are conditional upon customary conditions including regulatory review by the appropriate regulatory agencies under the Hart-Scott-Rodino Act.

GlaxoSmithKline and Vir Biotechnology entered into the initial strategic collaboration in April 2020 to research and develop solutions for coronaviruses, including SARS-CoV-2 (the virus that causes COVID-19). The focus of the collaboration to date has been the development of specific antibody candidates identified by Vir’s mAb platform, VIR-7831 and VIR-7832, which have demonstrated the potential to not only block both viral entry into healthy cells and clear infected cells, but to also provide a high barrier to resistance.

VIR-7831 & VIR-7832

VIR-7831 is currently in two global Phase 3 studies as monotherapy and one Phase 2 study as combination therapy with initial results from the first of the Phase 3 studies expected in the first quarter of 2021.

VIR-7832 has been accepted into the NHS-supported AGILE Phase 1b/2a study with a planned start in February 2021.

Vir Biotechnology Antibody Platform

Vir Biotechnology has a robust method for capitalizing on unusually successful immune responses naturally occurring in people who are protected from, or have recovered from, infectious diseases.

The platform is used to identify rare antibodies from survivors that have the potential to treat and prevent rapidly evolving &/or previously untreatable pathogens via direct pathogen neutralization and immune system stimulation. Vir engineers the fully human antibodies that it discovers to enhance their therapeutic potential. This 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 U.S. as EbangaTM and marketed by Ridgeback Therapeutics LP), malaria and others.

VIR-2482 – an investigational intramuscularly administered influenza A-neutralizing monoclonal antibody. In vitro, it 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. It has the potential to overcome the limitations of current flu vaccines and lead to meaningfully higher levels of protection due 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-7831 – an investigational dual-action SARS-CoV-2 monoclonal antibody. Preclinical data suggest it has the potential to both block viral entry into healthy cells and clear infected cells. The antibody binds to an epitope on SARS-CoV-2 that is shared with SARS-CoV-1 (the virus that causes SARS), indicating that the epitope is highly conserved, which may make it more difficult for resistance to develop. VIR-7831 also has been designed to achieve high concentration in the lungs to ensure optimal penetration into airway tissues affected by SARS-CoV-2 and to have an extended half-life.

VIR-7832 – an investigational dual-action SARS-CoV-2 monoclonal antibody. Preclinical data suggest it has the potential to both block viral entry into healthy cells and an enhanced ability to clear infected cells. The antibody binds to an epitope on SARS-CoV-2 that is shared with SARS-CoV-1 (the virus that causes SARS), indicating that the epitope is highly conserved, which may make it more difficult for resistance to develop. VIR-7832 also has been designed to achieve high concentration in the lungs to ensure optimal penetration into airway tissues affected by SARS-CoV-2 and to have an extended half-life.

VIR-7832 has also been engineered to potentially enhance virus-specific T cell function, which could help treat &/or prevent COVID-19 infection. 

More About the Vir Biotechnology and GlaxoSmithKline Collaboration 

As mentioned above, in April 2020, Vir and GSK entered into a collaboration to research and develop solutions for coronaviruses, including SARS-CoV-2. The collaboration uses Vir’s proprietary mAb platform technology to accelerate existing and identify new anti-viral antibodies that could be used as therapeutic or preventive options to help address the current COVID-19 pandemic and future outbreaks.

The companies are leveraging GSK’s expertise in functional genomics and combine their capabilities in CRiSPR screening and artificial intelligence to identify anti-coronavirus compounds that target cellular host genes. 

Vir Biotechnology

Vir Biotechnology – a clinical-stage immunology company focused on combining immunologic insights with cutting-edge technologies to treat and prevent serious infectious diseases. Vir has assembled four technology platforms that are designed to stimulate and enhance the immune system by exploiting critical observations of natural immune processes. Its current development pipeline consists of product candidates targeting COVID-19, hepatitis B virus, influenza A and human immunodeficiency virus.

For more information, please visit the Vir Biotechnology website by clicking here. 

GlaxoSmithKline

GlasxoSmithKline – a science-led global healthcare company with a special purpose: to help people do more, feel better and live longer.

For more information, please visit the GlaxoSmithKline website by clicking here.

Prohost Observations 

The expanded agreement between VIR and GSK opened eyes to Vir’s solid scientific fundamentals and on the firm’s expected outperformance in the future, which may have already begun thanks to this new, expanded and very promising agreement with regard to fighting infectious diseases.

Please visit our website to read more about Vir Biotechnology and GlaxoSmithKline.