Vir Biotechnology Announces Initiation of Phase 1 Clinical Trial to Evaluate a Novel Vaccine Platform
- Category: Vaccines
- Published on Wednesday, 06 January 2021 18:13
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– Culmination of a decade-long collaboration with Oregon Health & Science University and the Bill & Melinda Gates Foundation –
SAN FRANCISCO, CA, USA I January 06, 2021 I Vir Biotechnology, Inc. (Nasdaq: VIR), a clinical-stage immunology company focused on treating and preventing serious infectious diseases, announced that the first patient was dosed in late December 2020 in a Phase 1 clinical trial of VIR-1111, an investigational human immunodeficiency virus (HIV) T cell vaccine. VIR-1111 is a proof-of-concept vaccine designed to test the hypothesis that this new approach can elicit potentially protective immune responses that differ from other HIV vaccines. VIR-1111 is uniquely designed to elicit abundant and durable CD4 and CD8 T cells that are programmed to attack virus-infected cells. This trial is being conducted in collaboration with Oregon Health & Science University’s (OHSU) Vaccine and Gene Therapy Institute with support from the Bill & Melinda Gates Foundation.
“We are pleased to have initiated the first Phase 1 trial to evaluate our T cell platform, which explores the potential for immune-programmed vaccines to treat and prevent serious infectious diseases like HIV,” said Herbert “Skip” Virgin, M.D., Ph.D., chief scientific officer of Vir. “If observed, a programmed immune response could be a significant step forward in the fight against HIV and in the field of vaccines, with ramifications that could extend to other challenging areas like cancer immunotherapy.”
The randomized, placebo-controlled, Phase 1 clinical trial is evaluating the safety and immunogenicity (ability to induce an immune response) of VIR-1111. The trial is enrolling healthy adults (ages 18 to 50) who are considered to be at low risk of HIV infection and who were previously infected with human cytomegalovirus (HCMV). They will receive two doses of VIR-1111 or placebo given by subcutaneous injection and be assessed for safety, reactogenicity (common, expected adverse reactions following vaccination, such as pain and redness), tolerability and immunogenicity.
The viral vector technology that will be used in this trial was developed in a collaboration between Vir scientists and a team of OHSU scientists led by Louis Picker, M.D., and Klaus Frueh, Ph.D.
“Along with the many OHSU investigators who worked on this project over the years, we are very excited that this new vaccine platform is being evaluated in a clinical trial,” Drs. Picker and Frueh said. “This marks the first time that this new type of vaccine is being tested in humans. If successful, this approach could provide an entirely new set of tools for vaccine development.”
Key publications highlighting the potential impact of this approach include:
- CD8+ T cell programming by cytomegalovirus vectors: applications in prophylactic and therapeutic vaccination (Current Opinion in Immunology, 2017);
- A live-attenuated RhCMV/SIV vaccine shows long-term efficacy against heterologous SIV challenge (Science Translational Medicine, 2017);
- Enhancing safety of cytomegalovirus-based vaccine vectors by engaging host intrinsic immunity (Science Translational Medicine, 2017);
- Broadly targeted CD8+ T cell responses restricted by major histocompatibility complex E (Science, 2016); and
- Cytomegalovirus vectors violate CD8+ T cell epitope recognition paradigms (Science, 2013).
VIR-1111 is a 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 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 SARS-CoV-2, hepatitis B virus, influenza A, human immunodeficiency virus and tuberculosis. For more information, please visit www.vir.bio.
SOURCE: Vir Biotechnology