HOOKIPA Announces First Person Dosed in Phase 1a/b Clinical Trial of HB-400, in Collaboration with Gilead, for Treatment of Hepatitis B

NEW YORK and VIENNA, Austria, May 09, 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 first person has been dosed in a Gilead-led Phase 1 clinical trial of HB-400, an investigational therapeutic vaccine for chronic hepatitis B. HB-400 is one of two novel compounds being developed in collaboration with Gilead.

“Dosing of the first person in the Phase 1 clinical trial of HB-400 is an important milestone for HOOKIPA, as another program with our novel arenaviral technology progresses to the clinic,“ said Joern Aldag, Chief Executive Officer at HOOKIPA. ”More importantly, the start of the HB-400 trial is an important milestone for the hepatitis B community as hepatitis B remains an area of critical unmet need. We look forward to working with Gilead to assess the potential impact of our novel arenaviral technology as part of a combination regimen for people living with the disease.”

HB-400 is an alternating, 2-vector non-replicating arenaviral therapeutic vaccine for the treatment of chronic hepatitis B. It uses the lymphocytic choriomeningitis virus and pichinde virus as arenaviral backbones, with each expressing three highly conserved hepatitis B virus antigens. HOOKIPA’s alternating 2-vector approach is designed to optimize and focus the immune response against the target antigens.

The Phase 1 clinical trial (NCT05770895) aims to evaluate the safety and tolerability of repeated doses of HB-400 in healthy participants and participants with chronic hepatitis B. Gilead is solely responsible for further development and commercialization of HB-400, referenced as GS-2829 and GS-6779.

HOOKIPA earned a $5 million non-dilutive payment under its collaboration agreement in January 2023, following the submission of the clinical trial application (IND equivalent) and the completion of the regulatory support package for the Phase 1 clinical trial.

The hepatitis B program is one of two independent development programs in HOOKIPA’s collaboration and license agreement with Gilead. The other program aims to develop a novel arenaviral vaccine as a component of a potential functional curative regimen for human immunodeficiency virus (HIV). HOOKIPA is responsible for advancing the investigational HIV therapeutic vaccine through completion of a Phase 1b clinical trial.