AstriVax enters clinical phase with its novel vaccine platform technology

• The first participants have been dosed in SAFYR, a Phase I clinical trial to test the safety and efficacy of two prophylactic vaccines developed with AstriVax technology. 
• The study will also provide clinical proof of concept for the company’s platform technology. 
• Following these first-in-human data, AstriVax plans to advance its immunotherapies for chronic Hepatitis B to clinical development.

Leuven - June 24, 2024 - The first participants have been dosed in a Phase I clinical study to test the safety and efficacy of AstriVax’s prophylactic vaccines for yellow fever (AVX70120) and rabies (AVX70481) in healthy adults. The first-in-human safety and immunogenicity data generated by this study will be a stepping stone in advancing AstriVax immunotherapies to clear chronic infectionssuch as Hepatitis B and human papillomavirus (HPV) infections.

The company’s first-in-human clinical study, called SAFYR, will be conducted in two Belgium-based, world-class vaccine clinical trial sites: the Centre for Vaccinology in Ghent and Vaccinopolis in Antwerp. The study will evaluate the safety and characterize the immune response of the company’s prophylactic vaccines for yellow fever and rabies in close to 100 healthy adults aged 18 to 40. The results are also expected to provide clinical proof of concept for the AstriVax vaccine platform.

Mathieu Peeters, MD, Chief Development Officer at AstriVax: “This clinical trial evaluates our cutting-edge technology in a clinical proof-of-concept study. We use plasmids that deliver live-attenuated virus vectors along with the target viral antigen. This self-amplifying mechanism is designed to elicit strong and long-lasting immune responses with only microdoses.”

The novel AstriVax vaccines are potential game-changers in the fight against viral pathogens. Developed with the company’s innovative vaccine platform, they are easy to produce, have limited cold chain requirements, and are expected to trigger a strong and lasting immune response.

Paving the way for immunotherapies

Today, AstriVax is a clinical-stage company with a rich pipeline targeting viral infections, including treatment of infectious diseases with critical unmet medical needs like chronic Hepatitis B, which affects over 250 million people, and HPV infections, a leading cause of cervical cancer.

Hanne Callewaert, Ph.D., CEO and co-founder of AstriVax: “Less than two years ago, our journey began with solid, academically developed technology and a €30 million seed round. In May 2023, we were awarded a grant from Flanders Innovation & Entrepreneurship (VLAIO) to further advance our technology. I’m deeply grateful to my exceptional team for shaping the company into what it is today, and I look forward to continuing our journey towards better global health together. We anticipate our chronic hepatitis B immunotherapeutic will enter the clinical phase in 2025, marking yet another significant milestone for AstriVax. ”

Media contact

Hanne Callewaert, Ph.D, CEO of Astrivax, corporate@astrivax.com.

About AstriVax

Founded in 2022, AstriVax NV aims to address global challenges in vaccinology with its innovative plug-and-play vaccine platform. The company develops novel prophylactic and therapeutic vaccines that are easy to produce, have reduced cold chain requirements, and offer broad and long-lasting protection against various infectious diseases. AstriVax is supported by well-known investors V-Bio Ventures, Fund+, Flanders Future TechFund managed by PMV, Thuja Capital, Ackermans & van Haaren, OMX Europe Venture Fund (Mérieux Equity Partners and Korys), BNP Paribas Fortis Private Equity, and the KU Leuven Gemma Frisius Fund. AstriVax is located in the BioHub in Leuven. For more information, please visit astrivax.com.