HOOKIPA Pharma Begins Phase 1b Clinical Trial of HB-500 for HIV Treatment

HOOKIPA Pharma Inc., a biopharmaceutical company listed on NASDAQ under the ticker HOOK, has announced the commencement of a Phase 1b clinical trial for its investigational therapeutic vaccine, HB-500, aimed at treating HIV. This development marks a significant milestone, as it triggers a $5 million non-dilutive payment to HOOKIPA under its collaboration and license agreement with Gilead Sciences, Inc.

The Phase 1b clinical trial, identified by the code NCT06430905, is designed to assess the safety, tolerability, reactogenicity, and immunogenicity of HB-500 in patients with HIV who are already on suppressive antiretroviral treatment. The trial includes two dose escalation cohorts, with participants randomly assigned to receive either HB-500 or a placebo. The first participant was dosed on July 1, 2024, and the enrollment process is currently ongoing.

Joern Aldag, Chief Executive Officer of HOOKIPA, emphasized the global impact of HIV, which affects millions and currently has no cure. Current treatments can prevent the progression to AIDS but require lifelong adherence as they do not eliminate the virus. Aldag expressed optimism about HB-500’s potential, citing promising results from preclinical studies and the collaborative efforts with Gilead to reach this milestone.

Under the collaboration agreement, HOOKIPA is tasked with advancing the HIV program through the completion of the Phase 1b clinical trial. Post-trial, Gilead holds the exclusive rights to further develop the program. HB-500 is one of two developmental programs under the partnership between HOOKIPA and Gilead.

HB-500 consists of two genetically engineered replicating vectors derived from the arenaviruses Pichinde virus and lymphocytic choriomeningitis virus. These vectors are designed to deliver HIV antigens from key immunogenic regions of HIV type 1 (HIV-1) proteins, which are highly conserved within HIV-1 clade B variants. The immunogens in HB-500 vary in their amino acid sequences, allowing for coverage of over 80% of circulating HIV-1 viral variants.

HIV remains a significant global health challenge, with over 38 million people living with the virus worldwide. HIV targets and destroys immune cells, gradually weakening the immune system if untreated. While existing treatments have extended the lives of those infected and reduced transmission rates, there is still no cure for HIV or AIDS.

HOOKIPA Pharma Inc. is dedicated to developing innovative immunotherapies based on its proprietary arenavirus platform. The company’s technology aims to mobilize and amplify targeted T cells to combat serious diseases. HOOKIPA’s pipeline includes investigational immunotherapies for Human Papillomavirus 16-positive cancers, KRAS-mutated cancers, and other undisclosed programs. In collaboration with Gilead, HOOKIPA is also striving to develop functional cures for HBV and HIV.

As of now, HOOKIPA’s ongoing efforts in the Phase 1b clinical trial of HB-500 represent a pivotal step forward in the pursuit of a curative treatment for HIV, potentially transforming the lives of millions affected by this persistent virus.