In April 2020, Vir Biotechnology and GlaxoSmithKline enter into binding agreement to research, develop and commercialise products for the prevention, treatment and prophylaxis of COVID-2019 infections. Under the collaboration, both the parties will develop and commercialise monoclonal antibodies targeting SARS-CoV-2, and other coronaviruses; vaccines targeting SARS-CoV-2, and other coronaviruses and therapeutics based on genome-wide CRISPR screening of host targets expressed in connection with exposure to SARS-CoV-2 under the Functional Genomics Program. For a period of four years following the closing of the Stock Purchase Agreement (as mentioned below), the parties will conduct certain research and development activities for each of the three programs. Vir Biotechnology will be responsible for the development and clinical manufacturing activities for the antibody program, and for conducting the initial development activities directed to a vaccine for the vaccine program. GSK will be responsible for the commercialisation activities for the antibody program (except in People’s Republic of China, Hong Kong, Macau and Taiwan) and the later-stage development, manufacturing and commercialisation activities for the vaccine program and the development, manufacturing and commercialisation activities for the functional genomics program. Subject to an opt-out mechanism, the parties will share all development costs in accordance with the budget for each of the collaboration programs, with Vir Biotechnology bearing 72.5% of the development costs for the antibody program, 27.5% of the development costs for the vaccine program, and the both companies sharing equally the development costs for the functional genomics program. Under the Antibody Program, both the company will initialy advance the development of VIR 7831 and VIR 7832, for the treatment and prevention of COVID-2019 infections. In exchange of technology access of Vir Biotechnology, GlaxoSmithKline will make an equity investment of $US250 million in Vir Biotechnology. [2]
In March 2020, Vir Biotechnology and Generation Bio, entered into a research and development agreement to explore the potential of latter’s non-viral gene therapy platform to extend the impact and reach of Vir’s current or future human monoclonal antibodies (mAb) against SARS-CoV-2. Under the collaboration the companies aim to develop long-lasting therapies for both population-wide prevention and treatment. Generation Bio’s platform is designed to deliver genetic information directly to cells without the use of adeno-associated viruses (AAV), thereby instructing the patient’s body to produce the antibody itself. This approach may enable maintenance of stable levels of antibody expression for years, providing continuous protection against the target virus. The non-viral gene therapy platform coupled with Vir’s potent neutralizing antibodies, has the potential to provide effective, long-lasting protection against SARS-CoV-2. Other financial details of the agreement were not disclosed. [3]
In March 2020, Vir Biotechnology entered into a license agreement with Xencor to obtain non-exclusive access to Xencor's Xtend™ Fc technology to extend the half life of antibodies that are being developed by Vir Biotechnology for the potential treatment of COVID-19 infections. According to the terms of the agreement, the sole responsilibility of research, development, regulatory and commercial activities along with its costs, lies with Vir Biotechnology. Earlier, in August 2019, Vir Biotechnology had entered into a separate patent license agreement with Xencor, Inc. Under the terms of the agreement, Vir Biotechnology obtained a non-exclusive, sublicensable license to incorporate Xencor’s half-life extension Fc region-related technologies into, and to evaluate, antibodies that target influenza A and HBV, and a worldwide, non-exclusive, sublicensable license to develop and commercialize products containing antibodies incorporating such technologies for all uses, including the treatment, palliation, diagnosis and prevention of human or animal diseases, disorders or conditions. The Vir Biotechnology is obligated to use commercially reasonable efforts to develop and commercialize an antibody product that incorporates Xencor’s half-life extension Fc-related technologies, for each of the influenza A and HBV research programs. These technologies are used in the Vir Biotechnology VIR 2482 and VIR 3434 product candidates. In consideration for the grant of the license, the Vir Biotechnology paid Xencor an upfront fee. For each of the influenza A and HBV research programs, the company will be required to pay Xencor development and regulatory milestone payments of up to $US17.8 million in the aggregate, and commercial sales milestone payments of up to $US60.0 million in the aggregate, for a total of up to $US77.8 million in aggregate milestones for each program and $US155.5 million in aggregate milestones for both programs. On a product-by-product basis, the company will also be obligated to pay tiered royalties based on net sales of licensed products in the low single-digits. The royalties are payable, on a product-by-product and country-by-country basis, until the expiration of the last to expire valid claim in the licensed patents covering such product in such country [4] [5]
In March 2020, Vir Biotechnology signed a letter of intent with Biogen for the development and clinical manufacturing of human monoclonal antibodies for the treatment of COVID-19 infections. Subject to the completion of a definitive agreement, Biogen would continue cell line development, process development, and clinical manufacturing activities in order to advance the development of Vir’s proprietary antibodies. [6]
In March 2020, Vir Biotechnology entered into a research collaboration agreement with the National Institutes of Health (NIH) and the National Institute of Allergy and Infectious Diseases (NIAID) and Vaccine Research Center (VRC) to advance characterisation and development of human monoclonal antibodies against coronaviruses including SARS-CoV-2. Under the terms of the agreement Vir and NIAID will work together to identify and optimise combinations of antibodies against coronaviruses including SARS-CoV-2, SARS and MERS as well as antibodies that may be effective across additional types of coronaviruses. [7]
In February 2020, Vir Biotechnology entered into a development and manufacturing collaboration to advancer and produce human monoclonal antibodies for treatment of COVID-2019 infections. Under the terms of the agreement, the companies will work together on the clinical development, manufacturing, and commercialisation of proprietary antibodies of Vir Biotechnology. Cell-line development, process and formulation development as well as initial manufacturing for clinical development will be conducted by WuXi Biologics. Once regulatory approval are recieved, WuXi Biologics has the rights to commercialise therapies in Greater China, and Vir has the rights to commercialise therapies in all other markets worldwide. Financial details were not disclosed. [8]
