HIV Vaccine Investigational New Drug Application Clearance Issued

One of the world’s most formidable public health challenges, human immunodeficiency virus (HIV), is impacting more than 38 million people worldwide.

While there are no U.S. Food and Drug Administration (FDA) approved HIV vaccines in 2023, a novel arenaviral therapeutic vaccine candidate is being evaluated as a potential curative regimen for HIV.

HOOKIPA Pharma Inc. today announced that it has received clearance from the FDA for its Investigational New Drug (IND) application for HB-500, a novel arenaviral therapeutic vaccine for the treatment of HIV.

HB-500 is an alternating, 2-vector arenaviral therapeutic vaccine for the treatment of HIV.

One vector is based on the lymphocytic choriomeningitis virus as its arenaviral backbone; another vector is based on the 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.

HOOKIPA is responsible for advancing the HIV program through the completion of a Phase 1b clinical trial.

And Gilead Sciences, Inc. has the exclusive right to assume further program development afterward.

Joern Aldag, Chief Executive Officer at HOOKIPA, commented in a press release on November 20, 2023, “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 (candidate) offers promise in helping to address the unmet need for a functional HIV cure.”

In November 2023, Nature Partner Journals Vaccines published the joint-preclinical research by HOOKIPA and Gilead, which served as the foundation for the IND submission.

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.

Additionally, arenaviral therapeutic vaccination significantly reduced SIV viral load and clinical illness in those animals compared to placebo.

HIV, a sexually transmitted disease, is one of the world’s most formidable public health challenges.

The virus infects and kills immune cells and, without effective ongoing treatment, leaves the individual increasingly immunocompromised over time. While effective treatments have significantly extended the lives of people living with HIV and reduced the transmission of the virus, there is no cure for HIV or AIDS in 2023.