HOOKIPA Pharma Announces FDA Clearance of Investigational New Drug Application for HB-500, a Novel Arenavirus-Based Therapeutic Vaccine for HIV

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HB-500, a novel arenavirus-based therapy for HIV developed through a collaboration between Hookipa Pharma and Gilead Sciences, has received FDA clearance for an Investigational New Drug (IND) application. Preclinical studies on this therapy, published in Nature Partner Journals (NPJ) Vaccines, provide preclinical proof-of-concept for future trials.

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Analysis of the Simian Immunodeficiency Virus (SIV) model shows that the vaccine has excellent tolerance in non-human primates and elicits a strong, high-quality, and durable immune response. Vaccination with the arenavirus-based therapeutic significantly reduced SIV viral load and clinical disease in the animals, showing a marked difference compared to the placebo.

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HB-500 is a novel 2-vector arenavirus therapeutic vaccine designed to combat HIV. The vaccine utilizes two vectors, one based on Lymphocytic Choriomeningitis Virus (LCMV) and the other on Pichinde Virus (PICV), both encoding the same HIV antigen. This 2-vector approach aims to further enhance the immune response against the target antigen.