Vir Biotechnology Receives Expanded Support to Develop Its Novel T Cell Vaccine Platform with New $10 Million Grant for HIV Prevention

– New grant from the Bill & Melinda Gates Foundation supports the Phase 1 development of VIR-1388, an investigational HIV T cell vaccine based on a novel vector –

– Long-standing partnership further advances research for the prevention and treatment of global infectious diseases –

SAN FRANCISCO, May 02, 2023 (GLOBE NEWSWIRE) —  Vir Biotechnology, Inc. (Nasdaq: VIR) today announced that it received a new $10 million grant from the Bill & Melinda Gates Foundation to support Vir’s novel T cell vaccine development program. The new grant will support the Phase 1 clinical development of VIR-1388, an investigational novel T cell vaccine for the prevention of human immunodeficiency virus (HIV). VIR-1388 is based on the human cytomegalovirus (HCMV) vector platform. Using applied learnings from VIR-1111, Vir’s initial investigational proof-of-concept HIV T cell vaccine, VIR-1388 is designed to elicit T cells that recognize different HIV epitopes with the goal of creating a safe and effective HIV vaccine. Through close scientific partnership with the National Institute of Allergy and Infectious Diseases (NIAID) and the HIV Vaccine Trials Network (HVTN), the Phase 1 trial of VIR-1388 (HVTN 142) is expected to begin in the second half of 2023. The trial will also be funded in part by NIAID, part of the National Institutes of Health, through grant funding to HVTN. NIAID has provided funding throughout the product development lifecycle of VIR-1388.

“Vir’s long-standing support from the Bill & Melinda Gates Foundation has been a formative part of our company history in global health,” said Rajesh Gupta, M.D., M.S., M.P.H., Vice President, Global Health Portfolio and Public-Private Partnerships at Vir Biotechnology. “This new grant underscores the importance of our goal of developing innovative solutions for the prevention and treatment of global infectious diseases, including HIV. We look forward to advancing VIR-1388 into the clinic later this year.”

Vir’s support from the Bill & Melinda Gates Foundation includes existing equity investments and grants for the development of therapies for the prevention and treatment of HIV, the prevention of tuberculosis and the prevention of malaria. Collectively, these programs aim to address infectious diseases that significantly impact people in low- and middle-income countries. Currently, VIR-1111 is the most advanced program in this collaboration. The Company expects safety and immunology data from the highest dose cohort 3 in the proof-of-concept Phase 1 trial of VIR-1111 in the first half of 2023.

HIV continues to be a major global public health challenge with no cure for the approximately 38 million people living with HIV infection.

About VIR-1388
VIR-1388 is a pre-clinical subcutaneously administered HIV T cell vaccine based on HCMV that has been designed to elicit abundant T cells that recognize HIV epitopes in a way that differs from prior HIV vaccines.

About VIR-1111
VIR-1111 is an investigational subcutaneously administered HIV T cell vaccine based on HCMV that has been designed to elicit abundant T cells that recognize HIV epitopes in a way that differs from prior HIV vaccines.

About Vir Biotechnology
Vir Biotechnology is a commercial-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 and D viruses, influenza A and human immunodeficiency virus. Vir routinely posts information that may be important to investors on its website.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “may,” “will,” “plan,” “potential,” “aim,” “expect,” “anticipate,” “promising” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Vir’s expectations and assumptions as of the date of this press release. Forward-looking statements contained in this press release include, but are not limited to, statements regarding Vir’s collaboration with the Bill & Melinda Gates Foundation; the potential application of Vir’s novel T cell vaccine program for the prevention of HIV; potential of, and expectations for, Vir’s pipeline; and Vir’s clinical development programs, clinical trials and data readouts and presentations. Many important factors may cause differences between current expectations and actual results, including unexpected safety or efficacy data or results observed during clinical trials or in data readouts; the timing and outcome of Vir’s planned interactions with regulatory authorities; difficulties in obtaining regulatory approval; uncertainty as to whether the anticipated benefits of Vir’s collaborations with other companies can be achieved; difficulties in collaborating with other companies; challenges in accessing manufacturing capacity; clinical site activation rates or clinical trial enrollment rates that are lower than expected; successful development and/or commercialization of alternative product candidates by Vir’s competitors; changes in expected or existing competition; delays in or disruptions to Vir’s business or clinical trials due to the COVID-19 pandemic, geopolitical changes or other external factors; and unexpected litigation or other disputes. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical trials may not be indicative of full results or results from later-stage or larger-scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements, or the scientific data presented. Other factors that may cause actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Vir’s filings with the US Securities and Exchange Commission, including the section titled “Risk Factors” contained therein. Except as required by law, Vir assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.

CONTACT: Contact:
Carly Scaduto
Senior Director, Media Relations
cscaduto@vir.bio
+1-314-368-5189