Key Highlights:

• Naobios and Sumagen Canada announced the production of the HIV-1 vaccine candidate at bench scale.
• This key milestone puts Naobios in a position to scale up the production of Sumagen’s HIV-1 vaccine candidate following a partnership agreement signed in April 2024 to manage the manufacturing process.
• In the Phase I clinical trial, SAV001 demonstrated both tolerance and safety for human use and all subjects vaccinated with SAV001 produced broadly neutralising antibodies.

Naobios, a CDMO providing bioprocess development and GMP production of clinical batches of virus-based products, and Sumagen Canada Inc, a Korean-Canadian biotechnology company developing an HIV-1 vaccine candidate, announced the production of the HIV-1 vaccine candidate at bench scale.

This key milestone puts Naobios in a position to scale up the production of Sumagen’s HIV-1 vaccine candidate following a partnership agreement signed in April 2024 to manage the manufacturing process. Naobios has achieved this within the initial schedule, bringing Sumagen closer to delivering its HIV vaccine candidate to the public. This was made possible through the Naobios’ site, which has the required BSL3 production capabilities for highly pathogenic viruses.

“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 patients in need,” said Dr Sangkyun Lee, president of Sumagen.

Sumagen’s HIV vaccine candidate (SAV001) is a genetically modified, whole-killed HIV vaccine which represents the first of its kind in HIV vaccine trials. In the Phase I clinical trial, SAV001 demonstrated both tolerance and safety for human use. All subjects vaccinated with SAV001 produced broadly neutralising antibodies.

Naobios and Sumagen will now focus on industrial scale-up activities up until mid-2025, followed by cGMP production to bring Sumagen’s HIV-1 vaccine candidate into phase I/II clinical trials.

“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 be working with innovators like Sumagen who have the ability to significantly impact global human health,” added Eric Le Forestier, general manager of Naobios.

At the end of 2022, the World Health Organization (WHO) reported that approximately 39 million people were living with HIV. The development of an HIV vaccine has been a huge challenge for the medical community. With Naobios’ experience working with several dozen cell types and viral strains, the company is well-positioned to support Sumagen in its goal of delivering an HIV vaccine to patients with high unmet needs.