- Naobios achieves a critical development milestone for Sumagen’s HIV-1 vaccine candidate.
- Scale-up to support phase I/II trials is planned to begin by end of 2025.
Naobios has reached a critical milestone in the production of an HIV-1 vaccine candidate for Korean-Canadian biotechnology firm Sumagen Canada Inc. The achievement marks the completion of bench-scale production of Sumagen’s SAV001 vaccine, a genetically modified, whole-killed HIV vaccine designed to offer both tolerance and safety in human applications, as shown in earlier phase I trials.
The bench-scale production milestone will enable Naobios, a Contract Development and Manufacturing Organisation (CDMO) based in France, to proceed with the vaccine’s scale-up and cGMP production. The process is expected to pave the way for phase I/II clinical trials by late 2025. Dr Sangkyun Lee, President of Sumagen, commented on the achievement, saying, “This milestone 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.”
Naobios has a strong history in viral process development, which played a central role in meeting Sumagen’s project timeline, despite previous delays related to the Covid-19 pandemic. Naobios’s General Manager, Eric Le Forestier, emphasised the company’s expertise in the field, noting that achieving this stage within the planned timeframe “speaks volumes of our capabilities and decades of experience in viral process development.”
Overview of outsourcing trends 
