Naobios And Sumagen Advance Production Of A Promising HIV-1 Vaccine, Nearing Clinical Trial Readiness

Naobios, a CDMO specialising in bioprocess development and GMP production for virus-based products, and Sumagen Canada Inc., a biotech company focused on developing an HIV-1 vaccine, have achieved a significant milestone with the successful bench-scale production of Sumagen's HIV-1 vaccine candidate.

Dr Sangkyun Lee, president of Sumagen, said, “We are thrilled to have reached such a strategic industrial milestone within expected initial timelines, which is extremely significant due to the initial project delays resulting from the Covid-19 pandemic. This achievement solidifies our trust in Naobios to help our HIV-1 vaccine reach the crucial phase II trials, bringing us closer to delivering a vaccine to needy patients.”

The two companies agreed to collaborate in April 2024, and Naobios decided to spearhead the manufacturing. With this initial production phase now concluded on schedule, Naobios is poised to expand production, bringing Sumagen close to delivering the promising HIV-1 vaccine candidate to the public. Its state-of-the-art facility was instrumental in reaching this milestone, especially since it had BSL3 capabilities to handle high-risk viruses.

Sumagen’s vaccine candidate, SAV001, is unique as the first genetically modified, whole-killed HIV vaccine to enter human trials. In earlier Phase I trials, SAV001 showed both safety and tolerance, with all participants producing broadly neutralising antibodies after vaccination.

Eric Le Forestier, general manager of Naobios, also commented, “To have reached the process development and optimisation stage within the challenging initial planned timelines speaks volumes of our capabilities and decades of experience in viral process development. We are proud to work with innovators like Sumagen who can significantly impact global human health.”

Naobios and Sumagen will target industrial-scale-up activities from mid-year 2025, as this sets in cGMP production of the product for Phase I/II clinical trials. According to WHO reports, HIV has left the lives of 39 million people unchanged in 2022; this vaccine holds a broad scope for impacts. Experienced across all sorts of cellular types and strains of the virus, Naobios will position themselves to serve Sumagen by targeting an enormous unmet medical need.