Naobios, a CDMO specializing in virus-based product development and GMP production, and Sumagen Canada Inc., a biotechnology company, have announced a significant advancement in the production of Sumagen’s HIV-1 vaccine candidate, SAV001. The successful bench-scale production marks a critical step towards larger-scale manufacturing and clinical trials.
Sumagen's SAV001 is a genetically modified, whole-killed HIV vaccine. It has already demonstrated a favorable safety profile in Phase I trials, showing tolerance and safety in human subjects. This provides a solid foundation for further clinical development.
Advancing to Clinical Trials
This milestone enables Naobios to proceed with scaling up the production of the HIV-1 vaccine, followed by cGMP production. The goal is to initiate Phase I/II clinical trials by the end of 2025. This timeline reflects a commitment to expediting the vaccine's development, despite initial project delays caused by the COVID-19 pandemic.
"We are thrilled to have reached such a strategic industrial milestone within expected initial timelines... 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.
Leveraging Expertise for Global Impact
Naobios's expertise in viral process development has been instrumental in achieving this milestone within the planned timeframe. "To have reached the process development and optimization 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," said Eric Le Forestier, general manager of Naobios.
The collaboration between Naobios and Sumagen represents a significant step forward in the ongoing effort to develop an effective HIV-1 vaccine. The advancement to Phase I/II trials will provide critical data on the vaccine's efficacy and potential to address a significant global health need.
