Hookipa Pharma announces FDA clearance of IND application for HB-500

HOOKIPA Pharma announced that the Company has received clearance from the U.S. Food and Drug Administration for its Investigational New Drug application for HB-500, a novel arenaviral therapeutic vaccine for the treatment of HIV. HOOKIPA is responsible for advancing the HIV program through the completion of a Phase 1b clinical trial. Gilead has the exclusive right to assume further development of the program thereafter. Nature Partner Journals Vaccines recently published the joint-preclinical research by HOOKIPA and Gilead, which served as the foundation for the IND submission. The analyses published were conducted with a simian immunodeficiency virus model, commonly used in a preclinical setting as a surrogate to HIV. The data show that: Arenaviral therapeutic vaccination was well tolerated and generated robust, high-quality and durable immune responses in non-human primates; and, Arenaviral therapeutic vaccination significantly reduced SIV viral load and clinical illness in those animals compared to placebo. HB-500 is an alternating, 2-vector arenaviral therapeutic vaccine for the treatment of HIV. One vector is based on lymphocytic choriomeningitis virus as its arenaviral backbone; another vector is based on Pichinde virus. Both encode the same HIV antigens. The alternating 2-vector approach is designed to further focus the immune response against the target antigen.