May 26, 2024

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You are Your Only Limit

Vir Biotechnology Announces Very first Participant Dosed in New

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Dependent on a novel human cytomegalovirus vector platform, VIR-1388 was created with the target of building a novel HIV vaccine –

Stage 1 demo supported by the Invoice & Melinda Gates Basis, the Nationwide Institute of Allergy and Infectious Illnesses and performed by the HIV Vaccine Trials Network –

SAN FRANCISCO, Sept. 20, 2023 (Globe NEWSWIRE) — Vir Biotechnology, Inc. (Nasdaq: VIR) right now introduced that the 1st participant has been dosed in a Stage 1 demo assessing the basic safety, reactogenicity and immunogenicity of VIR-1388, an investigational novel T cell vaccine for the avoidance of human immunodeficiency virus (HIV). The Business expects original details from the Phase 1 trial in the second fifty percent of 2024.

VIR-1388 is centered on the human cytomegalovirus (HCMV) vector platform and is designed to encourage the entire body to produce immune cells acknowledged as T cells that identify many HIV proteins in a way that differs from prior investigational HIV vaccines. VIR-1388 was created utilizing applied learnings from VIR-1111, the Company’s first investigational evidence-of-thought HIV T cell vaccine dependent on HCMV.

“HIV carries on to be a important global general public well being challenge with no permitted vaccines even with decades of investigate initiatives,” reported Carey Hwang, M.D., Ph.D., Vir’s Senior Vice President, Clinical Investigation, Head of Persistent Infection. “The initiation of our 1st medical demo assessing VIR-1388 is an essential medical milestone in our pursuit of establishing an HIV vaccine and we are grateful to all our associates for their assist of this Stage 1 trial. We are hopeful that our distinctive technique will help near the longstanding public health and fitness gap in HIV avoidance.”

The demo is supported by the Nationwide Institute of Allergy and Infectious Ailments (NIAID), element of the Nationwide Institutes of Health and fitness, and the Bill & Melinda Gates Basis. NIAID has furnished funding in the course of the item development lifecycle of VIR-1388, and the Foundation has also supported the Company’s growth of therapies for the therapy of HIV, the avoidance of tuberculosis and the avoidance of malaria. The Period 1 demo of VIR-1388 will consider position in both of those domestic and international web-sites inside of the federally funded HIV Vaccine Trials Community (HVTN) as examine HVTN 142.

The HCMV vector is a weakened variation of the virus that is built to supply the HIV vaccine content to the immune system without the need of creating disorder in the trial contributors. HCMV has been current in considerably of the international inhabitants for hundreds of years. Most people dwelling with HCMV working experience no indicators and are unaware that they are living with the virus. HCMV stays detectable in the overall body for daily life, which suggests it has the likely to deliver and then safely aid the system keep HIV vaccine product for a long interval of time, potentially overcoming the waning immunity observed with additional quick-lived vaccine vectors.

According to the Joint United Nations Programme on HIV/AIDS (UNAIDS), somewhere around 1.5 million people had been newly contaminated with HIV and around 650,000 folks globally died from AIDS-connected deaths in 2021.

Design and style of the Stage 1 Trial
The randomized, double-blind, placebo-controlled Phase 1 demo (NCT05854381) is assessing the security, reactogenicity and immunogenicity of a few distinct doses of VIR-1388 as opposed with placebo. The demo is intended to enroll about 95 contributors ages 18 to 55 who are not living with HIV, with current antibodies certain to HCMV and in over-all fantastic wellness as determined by health-related background, bodily test and laboratory tests.

The overall research design includes two elements. Section A is a direct-in stage enrolling a confined number of HCMV-good individuals of non-childbearing opportunity with a frequent basic safety checking agenda. Part B will grow enrollment to a broader population of HCMV-constructive participants, like people of childbearing possible. An optional long-term stick to-up study will increase study participation for up to three years put up to start with dose.

About VIR-1388
VIR-1388 is an investigational subcutaneously administered HIV T mobile vaccine centered on HCMV that has been built to elicit abundant T cells that understand HIV proteins in a way that differs from prior investigational HIV vaccines. VIR-1388 takes advantage of used learnings from VIR-1111, Vir’s preliminary investigational evidence-of-thought HIV T cell vaccine, with the aim of developing a safe and helpful HIV vaccine.

About VIR-1111
VIR-1111 is an investigational subcutaneously administered evidence-of-thought HIV T cell vaccine dependent on HCMV that has been made to elicit abundant T cells that understand HIV epitopes in a way that differs from prior HIV vaccines.

About Vir Biotechnology
Vir Biotechnology, Inc. is an immunology company concentrated on combining reducing-edge technologies to handle and stop infectious ailments and other critical ailments. Vir has assembled two technologies platforms that are created to encourage and boost the immune process by exploiting critical observations of pure immune processes. Its current scientific progress pipeline consists of solution candidates targeting hepatitis B and hepatitis delta viruses, influenza A and B, human immunodeficiency virus and COVID-19. Vir has numerous preclinical candidates in its pipeline, including RSV/MPV and HPV. Vir routinely posts information that may be essential to buyers on its web site.

Forward-Seeking Statements
This press launch contains forward-seeking statements inside the this means of the Private Securities Litigation Reform Act of 1995. Text this sort of as “may,” “will,” “plan,” “potential,” “aim,” “expect,” “anticipate,” “promising” and similar expressions (as effectively as other terms or expressions referencing long term functions, disorders or situations) are meant to recognize ahead-looking statements. These forward-wanting statements are centered on Vir’s anticipations and assumptions as of the date of this push launch. Forward-wanting statements contained in this push launch include things like, but are not constrained to, statements regarding Vir’s technique and programs the possible security and efficacy of VIR-1388 the timing, style and design and enrollment of the Period 1 clinical trial Vir’s ideas and anticipations for its HIV portfolio, such as VIR-1388 and hazards and uncertainties involved with drug enhancement and commercialization. A lot of critical factors may bring about variations among present-day anticipations and genuine success, including dangers that Vir may possibly not entirely enroll the Section 1 demo sudden protection or immune reaction information or success observed through the demo the prevalence of adverse basic safety functions challenges of unanticipated expenditures, delays or other unexpected hurdles difficulties in collaborating with other organizations effective enhancement and/or commercialization of substitute item candidates by Vir’s competitors changes in predicted or present competitiveness delays in or disruptions to Vir’s small business or clinical trials because of to the COVID-19 pandemic, geopolitical changes or other exterior components and sudden litigation or other disputes. Drug advancement and commercialization include a high diploma of threat, and only a tiny range of research and improvement plans final result in commercialization of a products. Benefits in early-stage medical trials might not be indicative of comprehensive effects or final results from afterwards-stage or bigger-scale clinical trials and do not guarantee regulatory approval. You ought to not put undue reliance on these statements or the scientific facts introduced. Other components that could bring about real effects to vary from those people expressed or implied in the forward-on the lookout statements in this press launch are discussed in Vir’s filings with the U.S. Securities and Trade Fee, which include the part titled “Risk Factors” contained therein. Besides as essential by law, Vir assumes no obligation to update any forward-hunting statements contained herein to mirror any change in anticipations, even as new facts gets to be offered.

            
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