HOOKIPA Pharma Announces FDA Clearance of its Investigational New Drug Application for HB-500 for the Treatment of Human Immunodeficiency Virus

• Novel arenaviral therapeutic vaccine, developed in collaboration with Gilead Sciences, Inc. (‘Gilead’), to be evaluated as a potential curative regimen for human immunodeficiency virus (HIV)
  
  
• Phase 1 trial to commence in the first half of 2024
  
  
• Nature Partner Journals (NPJ) Vaccines published peer-reviewed preclinical data that provides a preclinical proof of concept for the trial as the tested, representative vaccine design was safe, immunogenic, and efficacious
  

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:

• Arenaviral therapeutic vaccination was well tolerated and generated robust, high-quality and durable immune responses (antigen-specific T cells and antibodies) 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 (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.