Naobios, a CDMO (Contract Development and Manufacturing Organization) providing bioprocess development and GMP production of clinical batches of virus-based products, and Sumagen Canada Inc (Sumagen), a Korean-Canadian biotechnology company part of CreoSG Co., Ltd, has announced the production of Sumagen’s HIV-1 vaccine candidate at bench scale.
 
Sumagen candidate (SAV001) is a genetically modified, whole-killed HIV vaccine which demonstrated both tolerance and safety for human use in phase I trials.
 
This key milestone, achieved on schedule, will allow Naobios to scale up the production of Sumagen’s HIV-1 vaccine followed by cGMP production to launch phase I/II clinical trials by the end of 2025.
 
“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.
 
“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.