SAN FRANCISCO—Clinical-stage immunology company Vir Biotechnology has announced that the first patient has been dosed in the company’s Phase 1 clinical trial of VIR-1111, an investigational human immunodeficiency virus (HIV) T cell vaccine.
“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. 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.” stated Dr. Herbert “Skip” Virgin, chief scientific officer of Vir Biotechnology.
VIR-1111 is a proof-of-concept vaccine designed to test the hypothesis that this approach is capable of eliciting potentially protective immune responses that differ from other HIV vaccines. VIR-1111 is said to elicit abundant and durable CD4 and CD8 T cells that are programmed to attack HIV-infected cells. The trial is being conducted in collaboration with the Vaccine and Gene Therapy Institute at Oregon Health & Science University (OHSU), with support from the Bill & Melinda Gates Foundation.
The randomized, placebo-controlled, Phase 1 clinical trial is evaluating VIR-1111’s safety and immunogenicity. The trial is enrolling healthy adults aged 18 to 50 who are considered to be at low risk of HIV infection, and who were previously infected with human cytomegalovirus. Participants will receive two doses of VIR-1111 or placebo given by subcutaneous injection, and will be assessed for safety, reactogenicity, tolerability, and immunogenicity.
The viral vector technology used in this trial was developed in a collaboration between Vir scientists and a team of scientists at OHSU, led by Dr. Louis Picker and Dr. Klaus Frueh.
“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. 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,” explained Picker and Frueh.
Vir, along with GlaxoSmithKline, also has underway a Phase 3 trial of VIR-7831, a fully human anti-SARS-CoV-2 investigational monoclonal antibody. The trial, part of the National Institutes of Health’s Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) program, is designed to evaluate the safety and efficacy of VIR-7831 for the treatment of hospitalized adults with COVID-19. VIR-7831 was selected based on its potential to neutralize the virus, kill infected cells, provide a high barrier to resistance, and achieve high concentrations in the lungs.
“Recent data suggest that the neutralizing activity of antibodies may be insufficient to protect hospitalized adults from the most severe consequences of COVID-19,” noted Dr. George Scangos, chief executive officer of Vir. “We are hopeful that the differentiating factors and broad anti-coronavirus activity of VIR-7831 may allow it to help those patients and add to our preparedness for related coronaviruses that could emerge in the future.”