HOOKIPA Pharma Announces Enrollment Completion of Phase 1b Clinical Trial Evaluating HB-500 for the Treatment of HIV

Core Viewpoint - HOOKIPA Pharma Inc. is advancing the development of HB-500, a next-generation therapeutic vaccine for HIV, in collaboration with Gilead Sciences, with the completion of a Phase 1b clinical trial expected in the second half of 2025 [1][2][4]. Company Overview - HOOKIPA Pharma Inc. is a clinical-stage biopharmaceutical company focused on developing next-generation immunotherapeutics targeting cancer and serious infectious diseases [9]. - The company utilizes a proprietary arenavirus platform to create product candidates designed to induce robust CD8+ T cells and antibodies [9]. Clinical Trial Details - Enrollment in the Phase 1b clinical trial for HB-500 is complete, with 30 participants enrolled across five sites in the United States [2]. - The trial evaluates the safety, tolerability, reactogenicity, and immunogenicity of HB-500 in participants with HIV on suppressive antiretroviral treatment [4]. - The trial design includes two dose escalation cohorts, with participants randomized to receive either HB-500 or a placebo [4]. Collaboration with Gilead - HOOKIPA is responsible for advancing the HIV program through the completion of the Phase 1b clinical trial, after which Gilead has the exclusive right to assume further development [6]. - HB-500 is one of two developmental programs under the collaboration and license agreement with Gilead [6]. Vaccine Mechanism - HB-500 consists of two genetically engineered replicating vectors based on the Pichinde virus and lymphocytic choriomeningitis virus, designed to deliver HIV antigens that cover over 80% of circulating HIV-1 variants [7]. - The vaccine aims to induce robust and durable immunity as part of a combination strategy for a potential functional cure for HIV [5]. HIV Context - HIV remains a significant global public health challenge, with over 38 million people living with the virus worldwide [8]. - Current treatments have improved the lives of those with HIV, but there is still no cure for HIV or AIDS [8].