FRANCE – Naobios, a Contract Development and Manufacturing Organization (CDMO) specializing in bioprocess development and GMP production of virus-based products, has announced the bench-scale production of Sumagen Canada Inc.’s HIV-1 vaccine candidate.

Sumagen, a Korean-Canadian biotechnology company, is advancing an innovative HIV-1 vaccine candidate, and this latest development builds on Naobios’ ongoing progress in viral manufacturing partnerships.

This announcement follows closely after Naobios revealed its collaboration with the European Vaccine Initiative (EVI), a leading non-profit Product Development Partnership in Europe, aimed at manufacturing a Respiratory Syncytial Virus (RSV) challenge agent.

These collaborations reflect Naobios’ expanding role in scaling up virus-based therapeutics and vaccines, with the production of the HIV-1 vaccine candidate marking an essential milestone.

In April 2024, Naobios and Sumagen signed a partnership agreement to streamline the vaccine’s manufacturing process. This placed Naobios at the center of the scale-up efforts needed to propel Sumagen’s candidate toward clinical use.

Naobios leveraged its BSL-3 (Biosafety Level 3) production facility to achieve this milestone on schedule, providing Sumagen with an essential platform to advance its vaccine candidate despite initial project delays caused by the COVID-19 pandemic.

Dr. Sangkyun Lee, President of Sumagen, expressed enthusiasm for reaching this milestone on time, highlighting the significance of the progress given past setbacks.

He praised Naobios’ commitment, noting that it strengthens Sumagen’s trust in Naobios to advance SAV001, Sumagen’s HIV vaccine candidate, into the critical Phase II clinical trials, where it could bring hope to patients who need it most.

SAV001 is a genetically modified, whole-killed HIV vaccine—the first of its kind in HIV vaccine trials. In its Phase I trial, SAV001 demonstrated a robust safety profile, with vaccinated participants producing broadly neutralizing antibodies, a promising outcome for further clinical development.

Naobios and Sumagen are now set to proceed with the vaccine’s industrial scale-up. They plan to reach full-scale cGMP production by mid-2025 in preparation for Phase I/II clinical trials.

Eric Le Forestier, Naobios’s General Manager, emphasized that reaching the process development and optimization stages within tight timelines highlights Naobios’ capabilities and decades-long expertise in viral process development.

He voiced pride in collaborating with Sumagen, recognizing their work’s potential impact on global public health.

At the close of 2022, the World Health Organization (WHO) estimated that 39 million people were living with HIV, emphasising the urgent need for innovative solutions.

The challenge of developing an effective HIV vaccine has long been a priority for the global medical community.

With extensive experience working with various cell types and viral strains, Naobios remains poised to support Sumagen’s mission to deliver an effective HIV vaccine to meet the high unmet needs of patients worldwide.

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