HOOKIPA Pharma: HB-500 IND Application Gets FDA Clearance To Treat HIV

(RTTNews) - HOOKIPA Pharma Inc. (HOOK), the developer of a new class of immunotherapeutics based on its proprietary arenavirus platform, announced Monday the U.S. Food and Drug Administration clearance for its Investigational New Drug or IND application for HB-500 for the treatment of human immunodeficiency virus or HIV.

The phase 1 trial will now be commenced in the first half of 2024.

HIV virus infects and kills immune cells, and leaves the individual increasingly immunocompromised over time without effective ongoing treatment. Though there is no cure for HIV or AIDS, effective treatments have significantly extended the lives of people living with HIV and reduced the transmission of the virus.

The company said the novel arenaviral therapeutic vaccine, developed in collaboration with Gilead Sciences, Inc. (GILD), will be evaluated as a potential curative regimen for 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.

Joern Aldag, Chief Executive Officer at HOOKIPA, said, "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. 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."

The joint-preclinical research by HOOKIPA and Gilead served as the foundation for the IND submission. The preclinical data provides a preclinical proof of concept for the trial as the tested, representative vaccine design was safe, immunogenic, and efficacious.

HB-500 is one of two separate development programs in HOOKIPA's collaboration and license agreement with Gilead.

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