Vir Biotechnology Announces First Subject Dosed in New Phase 1 Trial Evaluating VIR-1388, an Investigational T-Cell Vaccine to Prevent HIV

Based on a novel human cytomegalovirus vector platform, VIR-1388 is designed to create a new HIV vaccine—

The Phase 1 trial is supported by the Bill & Melinda Gates Foundation, the National Institute of Allergy and Infectious Diseases, and conducted by the HIV Vaccine Trials Network –

San Francisco, September. February 20, 2023 (GLOBE NEWSWIRE) — VIR BIOTECHNOLOGY, Inc. (Nasdaq: VIR) today announced that the first participant has been evaluated in a study evaluating VIR-1388, an investigational novel T- cells) were administered in a phase 1 trial of safety, reactogenicity and immunogenicity. Vaccines used to prevent human immunodeficiency virus (HIV). The company expects to have preliminary data from the Phase 1 trial in the second half of 2024.

VIR-1388 is based on a human cytomegalovirus (HCMV) vector platform and is designed to stimulate the body’s production of immune cells called T cells, which recognize multiple HIV proteins in a manner different from previously studied HIV vaccines. VIR-1388 was developed using applied knowledge from VIR-1111, the company’s initial investigational proof-of-concept HIV T-cell vaccine based on HCMV.

“Despite decades of research efforts, HIV remains a major global public health challenge and a vaccine has not yet been approved,” said Carey Hwang, MD, PhD, Senior Vice President of Clinical Research and Head of Chronic Infections at Vir. The initiation of a clinical trial evaluating VIR-1388 is an important clinical milestone in our development of an HIV vaccine, and we thank all partners for their support of this Phase 1 trial. “We hope our unique approach will help narrow the gap between HIV and Persistent public health gaps in prevention. “

The trial is supported by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, and the Bill & Melinda Gates Foundation. NIAID provides funding throughout the product development life cycle of VIR-1388, and the foundation also supports the company’s development of therapies to treat HIV, prevent tuberculosis, and prevent malaria. The Phase 1 trial of VIR-1388 will be conducted at domestic and international sites within the federally funded HIV Vaccine Trials Network (HVTN), study number HVTN 142.

HCMV vectors are weakened versions of the virus designed to deliver HIV vaccine materials to the immune system without causing illness in trial participants. HCMV has been present in much of the global population for centuries. Most people infected with HCMV have no symptoms and do not know they have the virus. HCMV is detectable throughout life in the body, suggesting its potential to deliver and subsequently safely help the body retain HIV vaccine material for long periods of time, potentially overcoming the waning immunity observed with shorter-lived vaccine vectors.

According to the Joint United Nations Program on HIV/AIDS (UNAIDS), approximately 1.5 million people worldwide will be newly infected with HIV in 2021, and approximately 650,000 people will die from AIDS-related deaths.

Phase 1 Trial Design
Randomized, double-blind, placebo-controlled phase 1 trial (NCT05854381) Three different doses of VIR-1388 are being evaluated for safety, reactogenicity and immunogenicity compared with placebo. The trial aims to recruit approximately 95 participants ages 18 to 55 who are HIV-free, have HCMV-specific antibodies, and are generally in good health as determined by medical history, physical examination and laboratory testing.

The overall research design consisted of two parts. Part A is a lead-in phase with frequent safety surveillance of a limited number of HCMV-positive persons of non-reproductive potential. Part B will expand recruitment to cover a wider range of HCMV-positive participants, including those of childbearing potential. An optional long-term follow-up study will increase study participation up to three years after the first dose.

About VIR-1388
VIR-1388 is an investigational, subcutaneous, HCMV-based HIV T-cell vaccine designed to prime large numbers of T cells to recognize HIV proteins in a manner different from previous investigational HIV vaccines. VIR-1388 leverages experience from Vir’s initial investigational proof-of-concept HIV T-cell vaccine, VIR-1111, with the goal of creating a safe and effective HIV vaccine.

About VIR-1111
VIR-1111 is an investigational, subcutaneous, HCMV-based HIV T-cell vaccine designed to prime large numbers of T cells to recognize HIV epitopes in a manner different from previous HIV vaccines.

About Vir Biotechnology
Vir Biotechnology, Inc. is an immunology company focused on combining cutting-edge technologies to treat and prevent infectious diseases and other serious diseases. Vir has assembled two technology platforms designed to stimulate and enhance the immune system by leveraging key observations of natural immune processes. Its current clinical development pipeline includes product candidates targeting hepatitis B and D viruses, influenza A and B, human immunodeficiency virus and COVID-19. Vir is developing multiple preclinical drug candidates, including RSV/MPV and HPV. Vir frequently posts information on its website that may be important to investors.

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,” “goal,” “expect,” “anticipate,” “hopefully” and similar expressions (as well as references to future events, conditions or (other words or expressions of context) 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 strategy and A statement of plans; the potential safety and efficacy of VIR-1388; the timing, design and recruitment of Phase 1 clinical trials; Vir’s plans and expectations for its HIV product portfolio, including VIR-1388; and drug development and commercialization Related risks and uncertainties. Many important factors could cause current expectations to differ from actual results, including the risk that Vir may not fully enter Phase 1 trials; unexpected safety or immune response data or results observed during trials; adverse the occurrence of safety incidents; the risk of unexpected costs, delays or other unexpected obstacles; difficulties in collaborating with other companies; the success of Vir’s competitors in developing and/or commercializing alternative product candidates; changes in anticipated or existing competition; due to COVID-19 Delays or interruptions in Vir’s operations or clinical trials caused by the 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 few research and development projects lead to commercialization of products . Results from early-stage clinical trials may not be representative of the full results or results of later-stage or larger clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements or the scientific data presented. Vir to U.S. Securities Exchange Additional factors that could cause actual results to differ from those expressed or implied by the forward-looking statements in this release are discussed in the Commission’s filings, including in the section titled “Risk Factors” therein. Vir disclaims any obligation to update except as required by law Any forward-looking statements contained herein are intended to reflect changes in expectations, even if new information becomes available.




Contacts:

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

Investors
Sasha Damouni Ellis
Executive Vice President, Chief Corporate Affairs Officer
sdamouni@vir.bio

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