AstriVax Therapeutics has commenced clinical development of AVX70371, a novel immunotherapy targeting chronic hepatitis B virus (HBV) infection that could potentially offer a functional cure for over 250 million patients worldwide suffering from this chronic condition.
The Belgian clinical-stage immunotherapy company announced the initiation of the Phase I RUBY study (NCT06989788), which will evaluate the safety, tolerability and immunogenicity of repeated injections of AVX70371 in 16 healthy adult volunteers at the Centre for Vaccinology of the Ghent University, Belgium. All subjects have now received their first dose of AVX70371 as part of a multiple dosing schedule.
Targeting Immune Exhaustion in Chronic HBV
AVX70371 has been specifically designed to elicit a targeted T-cell immune response against infected hepatocytes where HBV is actively replicating. This approach addresses a critical challenge in chronic hepatitis B treatment, as patients with this condition are known to experience HBV-specific immune exhaustion.
"AVX70371 has been designed to elicit a specific T-cell immune response against infected hepatocytes in which HBV is actively replicating. Knowing that patients with chronic hepatitis B suffer from immune exhaustion, this targeted immunotherapy approach is expected to intervene at the source of the chronic viral infection," said Mathieu Peeters, M.D., Chief Development Officer at AstriVax Therapeutics.
Launch-iT Platform Validation
The trial represents the third asset from AstriVax's proprietary Launch-iT technology platform to advance into clinical trials, validating the broad potential of this plasmid-based approach. The Launch-iT platform can rapidly generate viral vectors encoding novel antigens of interest as immunotherapy drug candidates.
The platform's tolerability and effectiveness were previously validated in the SAFYR clinical study, which demonstrated that a single injection with AVX70120 (Yellow fever) or AVX70481 (Rabies) was very well tolerated and could induce high and long-lasting antibody titers and T-cell counts including CD4 and CD8 T-cells.
Clinical Timeline and Future Development
Up to three doses of AVX70371 are being evaluated in preparation for assessment in a chronic HBV patient population. The trial is expected to be completed in the second half of 2026, with an interim analysis planned before the end of 2025.
"Following positive results from our first clinical study in 2024, which evaluated the safety and immunogenicity of our Launch-iT technology platform, starting the clinical development with our first therapeutic Launch-iT program is a significant milestone for AstriVax Therapeutics," said Hanne Callewaert, Ph.D., co-founder and CEO of AstriVax Therapeutics.
Addressing Unmet Medical Need
Despite the availability of preventive vaccines, chronic hepatitis B continues to affect over 250 million people worldwide, creating an ongoing need for improved treatment options beyond life-long antiviral therapy. The company positions AVX70371 as a potential first-in-class treatment that could form part of a functional cure approach.
"Despite available preventive vaccines, chronic hepatitis B still affects over 250 million people worldwide, so there is an ongoing need for improved options for patients beyond life-long antiviral treatment," Callewaert noted.
Expanding Pipeline
AstriVax Therapeutics is also in the process of selecting a second immunotherapy Launch-iT clinical candidate for treating human papilloma virus (HPV) infection, with plans to rapidly advance this program towards clinical development in patients. This expansion further supports the company's track record of moving assets quickly into the clinical validation phase.
The Launch-iT product candidates are designed to be easy to produce, have limited cold chain requirements, and are expected to trigger strong and lasting immune responses, positioning them as potential game-changers in the fight against viral pathogens.
