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The Clinical Trials Industry’s Weekly News Update

Naobios declares FluGen’s clinical batch of M2SR complete

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Naobios has completed the production of a clinical batch of influenza vaccine candidate M2SR, allowing FluGen to begin clinical trials in the US.

FluGen and contract development manufacturing organization (CDMO) Naobios have partnered on the process development of a platform for FluGen’s M2SR vaccine candidate since 2019 and have now reached a key milestone in the collaboration, which will lead to the start of a clinical trial in the US this month.

M2SR is a live, single-replication, supra-seasonal, intranasal flu vaccine. According to Naobios, unlike standard of care flu vaccines, M2SR has the ability to stimulate, humoral, mucosal, and cellular immunity.

“Contrary to most current commercial flu vaccines that are manufactured on embryonated chicken eggs and administered by injection, this vaccine is manufactured on cells and administered intranasally,” Eric Le Forestier, general manager of Naobios told us.

Naobios manufactured the vaccine at its facilities located in Nantes, France and Le Forestier said “the manufacturing process is proprietary. It has been developed by Naobios specifically for FluGen. The project has been conducted in 11 months in order to successfully meet the requirements of the clinical timelines.”

The “completion means the vaccine has been developed, manufactured, released and delivered to FluGen,” he continued, adding the two companies are planning further M2SR development going forward.

Image: Stock Photo Secrets

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