HB-400, a novel arenaviral therapeutic vaccine developed by HOOKIPA Pharma and Gilead Sciences, has been shown to generate robust T cell responses specific to hepatitis B virus with high antibody levels in a preclinical setting.
A Phase I clinical trial to evaluate the safety and tolerability of HB‑400 in humans is ongoing. Gilead is solely responsible for continued development and commercialisation of the vaccine (also known as GS-2829 and GS-6779).
HB-400 uses the lymphocytic choriomeningitis virus and pichinde virus as arenaviral backbones, with each expressing three highly conserved hepatitis B virus antigens. The alternating two-vector approach is designed to optimise and focus the immune response against the target antigens.
It is one of two independent development programs in HOOKIPA’s collaboration and license agreement with Gilead Sciences.
The preclinical data published in The Journal of Infectious Diseases show that:
- Immunisation with HB-400 induced robust, hepatitis B-specific T cell and antibody responses in non-human primates.
- HB-400 vaccination cleared detectable serum hepatitis B antigens in a mouse model for chronic HBV infection, with near elimination of detectable hepatitis B antigen positive hepatocytes in the liver.
“The lack of curative therapies for chronic hepatitis B infection is a significant barrier to addressing the global burden of disease,” said Joern Aldag, Chief Executive Officer at HOOKIPA. “We’re pleased to see our novel arenaviral platform technology featured in this reputable journal, and we look forward to seeing how clinical results of Gilead’s ongoing Phase I trial of HB-400 may further support its potential as a component of a functional cure regimen for hepatitis B.”