HOOKIPA Pharma Inc. (NASDAQ: HOOK) announced the completion of enrollment in its Phase 1b clinical trial evaluating HB-500 for the treatment of human immunodeficiency virus (HIV). The trial, conducted across five sites in the United States, enrolled a total of 30 participants.
The Phase 1b trial (NCT06430905) is designed to assess the safety, tolerability, reactogenicity, and immunogenicity of repeated doses of HB-500 in individuals with HIV who are on suppressive antiretroviral treatment. The trial employs a dose escalation design, with participants randomized to receive either HB-500 or a placebo.
HB-500: A Novel Immunotherapeutic Approach
HB-500 is a next-generation therapeutic vaccine being developed in collaboration with Gilead Sciences, Inc. as a potential component of a curative regimen for HIV. The vaccine comprises two genetically engineered replicating vectors based on arenaviruses. These vectors are designed to deliver HIV antigens derived from key, immunogenic regions of HIV-1 proteins that are highly conserved within HIV-1 clade B variants. The designed immunogens differ in their amino acid sequence, allowing for coverage of >80% of circulating HIV-1 viral variants.
According to Dan H. Barouch, M.D., Ph.D., Director of the Center of Vaccine and Virology Research, Beth Israel Deaconess Medical Center and Professor of Medicine, Harvard Medical School, "HB-500 is designed to induce robust and durable immunity and is a key component of a combination strategy for a potential functional cure of HIV using novel mechanisms aimed at driving viral suppression, durable immunity and eradication of the pro-viral reservoir."
Trial Design and Objectives
The Phase 1b trial's primary completion is anticipated in the second half of 2025. HOOKIPA is responsible for advancing the HIV program through the completion of this trial. Following the Phase 1b trial, Gilead has the exclusive right to assume further development of the program. The first participant was dosed on July 1, 2024.
HIV: A Persistent Global Health Challenge
HIV remains a significant global health challenge, with an estimated 38 million people living with the virus worldwide. HIV infects and destroys immune cells, leading to increased immunocompromisation if left untreated. While current treatments have significantly improved the lives of people with HIV, there is still no cure for HIV or AIDS.
HOOKIPA's Arenavirus Platform
HOOKIPA Pharma Inc. is a clinical-stage biopharmaceutical company focused on developing next-generation immunotherapeutics based on its proprietary arenavirus platform. The company's product candidates are designed to induce specific, robust, and durable CD8+ T cells and antibodies to eliminate cancers and serious infectious diseases. HOOKIPA's pipeline includes biological therapies for oncology, targeting human papillomavirus type 16-positive (HPV16+) cancers, KRAS mutated cancers, and other targets. In addition to the HIV program, HOOKIPA has partnered with Gilead Sciences, Inc. to develop therapies intended to provide functional cures for hepatitis B virus (HBV).
