“Completing enrollment in our Phase 1b trial marks an important milestone for the HB-500 program and our strategic collaboration with Gilead and speaks to the focus on operational excellence at Hookipa,” said Mark Winderlich, PhD, Chief Research & Development Officer of HOOKIPA.
The Phase 1b clinical trial (NCT06430905) is evaluating the safety and tolerability, reactogenicity, and immunogenicity to repeated doses of HB-500 in participants with HIV on suppressive antiretroviral treatment. The Phase 1b design comprises two dose escalation cohorts with participants randomized to receive HB-500 or placebo. The first participant was dosed on July 1, 2024, and primary completion is expected in the second half of 2025.
“HB-500 is designed to induce robust and durable immunity and is a key component of a combination strategy for a potential functional cure of HIV using novel mechanisms aimed at driving viral suppression, durable immunity and eradication of the pro-viral reservoir,” commented Dan H. Barouch, M.D., Ph.D., Director of the Center of Vaccine and Virology Research, Beth Israel Deaconess Medical Center and Professor of Medicine, Harvard Medical School.
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. HB-500 is one of two separate developmental programs in HOOKIPA’s collaboration and license agreement with Gilead.
About HB-500:
HB-500 comprises two genetically engineered replicating vectors based on the arenaviruses Pichinde virus and lymphocytic choriomeningitis virus, respectively. The HB-500 vectors have been engineered to deliver HIV antigens derived from parts of key, immunogenic regions of HIV type 1 (HIV-1) proteins that are highly conserved within HIV-1 clade B variants. The designed immunogens differ from each other by their amino acid sequence allowing for coverage of >80% of circulating HIV-1 viral variants.
About HIV:
HIV is one of the world’s most formidable public health challenges. It is estimated there are more than 38 million people living with HIV worldwide. 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 with HIV and reduced the transmission of the virus, there is no cure for HIV or AIDS.
About HOOKIPA:
HOOKIPA Pharma Inc. (NASDAQ: HOOK) is a clinical-stage biopharmaceutical company focused on developing next generation immunotherapeutics based on its proprietary arenavirus platform. The company’s product candidates are designed to induce specific, robust and durable CD8+ T cells and antibodies to eliminate cancers and serious infectious diseases. HOOKIPA’s pipeline includes biological therapies for oncology, targeting human papillomavirus type 16-positive (HPV16+) cancers, KRAS mutated cancers, and other targets. In addition, HOOKIPA has partnered with Gilead Sciences, Inc. to develop therapies that are intended to provide functional cures for hepatitis B virus (HBV) and human immunodeficiency virus-1 (HIV-1).
For more information please visit, www.hookipapharma.com.
