CDMO Naobios and Sumagen Canada have produced a HIV-1 vaccine candidate at bench scale.
This achievement will allow Naobios to scale up the production of Sumagen's HIV vaccine, allowing the company to deliver the product to the public — subject to regulatory approval.
The duo have been working together since April 2024, and will now focus on industrial scale-up until mid-2025.
Following this period of process development, Naobios will be responsible for the cGMP production of Sumagen's HIV-1 vaccine for Phase I/II clinical trials.
The vaccine's manufacture was made possible by Naobios' BSL3 production capabilities, which allow for the manufacture of highly pathogenic viruses.
Sumagen's HIV vaccine candidate (SAV001) is a whole-killed, genetically modified HIV vaccine, and is the first of its kind in this disease.
In a Phase I trial, SAV001 was both tolerant and safe for use in humans, with subjects receiving the vaccination producing broadly neutralising antibodies.
President of Sumagen, Dr Sangkyun Lee, commented: “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.”
General Manager of Naobios, Eric Le Forestier, added: “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,”