NANTES, France--(BUSINESS WIRE)--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, today announce the production of HIV-1 vaccine candidate at bench scale.
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.
Sumagen candidate (SAV001) is a genetically modified, whole-killed HIV vaccine which demonstrated both tolerance and safety for human use in phase I trials.
About Naobios
Naobios is a Contract Development and Manufacturing Organization (CDMO) providing bioprocess development and offering GMP production of clinical batches of BSL2/BSL3 viral vaccines, oncolytic viruses, viral vectors and challenge agents. Naobios joined the Clean Biologics group in 2019.
Having built up 15 years’ experience in bioprocess development, Naobios helps its clients to bring their drug candidates to the clinical stage as rapidly as possible – at the highest level of quality – whilst building on its technical know-how in scalable and industrial processes. With its adaptability and range of skills, the company can lead a project from the initial stages through to completion, with a motivated and dedicated team. Its highly qualified staff have the experience to deal with a wide range of viruses, as well as multiple cell substrate lines. It currently has 40 staff.
