HOOKIPA Pharma Announces FDA Clearance of its Investigational New Drug Application for HB-500 for the Treatment of Human Immunodeficiency Virus
NEW YORK and VIENNA, Austria, Nov. 20, 2023 (GLOBE NEWSWIRE) -- HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, today announced that the Company has received clearance from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) 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.
“This marks our fourth active IND program at HOOKIPA—a further testament to the broad potential of our arenavirus platform across multiple disease areas and indications,” said Joern Aldag, Chief Executive Officer at HOOKIPA. “The ability to generate a potent and broad T cell response that can clear infected cells is critical for HIV control. Our novel arenaviral therapeutic vaccine offers promise in helping to address the unmet need for a functional HIV cure.”
Nature Partner Journals (NPJ) 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 (SIV) model, commonly used in a preclinical setting as a surrogate to HIV. The data show that:
HB-500 is an alternating, 2-vector arenaviral therapeutic vaccine for the treatment of HIV. One vector is based on lymphocytic choriomeningitis virus (LCMV) as its arenaviral backbone; another vector is based on Pichinde virus (PICV). Both encode the same HIV antigens. The alternating 2-vector approach is designed to further focus the immune response against the target antigen.
HB500 is one of two separate development programs in HOOKIPA’s collaboration and license agreement with Gilead.
Find out more about HOOKIPA online at www.hookipapharma.com.
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