" class="no-js "lang="en-US"> Naobios Manufactures FluGen Inc’s M2SR Influenza Vaccine Candidate for Upcoming Clinical Trials - Medtech Alert
Sunday, March 03, 2024

Naobios Manufactures FluGen Inc’s M2SR Influenza Vaccine Candidate for Upcoming Clinical Trials

Naobios, a CDMO (Contract Development and Manufacturing Organization) providing bioprocess development and GMP production of clinical batches of viral vaccines BSL2/BSL3, oncolytic viruses and viral vectors, today announces the next phase in its partnership with FluGen, Inc., a clinical-stage vaccine company transforming vaccine efficacy in infectious respiratory diseases. Naobios will initiate the GMP manufacturing of the clinical batches of FluGen’s M2SR influenza vaccine-candidate, in preparation for their upcoming clinical trials – commencing in 2022 in the United States.

Since 2019, Naobios and FluGen have collaborated on the process development of a scalable platform for FluGen’s M2SR vaccine. The company’s lead candidate is a supra-seasonal, live, single-replication, intranasal flu vaccine. Unlike standard of care flu vaccines, M2SR stimulates mucosal, humoral and cellular immunity.

“Manufacturing is a critical component of clinical trial execution; the success of a study is often highly dependent on the standards to which comparative viruses are developed,” said Paul Radspinner, president and CEO of FluGen, Inc. “We are pleased to continue our work with Naobios, a trusted partner that has consistently provided excellence in both standards and quality. We look forward to working with them throughout the execution of the clinical trials for our investigational intranasal M2SR influenza vaccine.”

“Cell-based manufacturing of influenza vaccines has been a vexing challenge for our industry for a long time. We are really excited by the results obtained so far during the process development and we’re looking forward to the manufacturing of this first GMP batch for FluGen’s clinical trials,” said Eric Le Forestier, general manager of Naobios. “This will take place as we continue with parallel scale-up for additional influenza strains. We are very proud of our partnership with FluGen; supporting its mission to bring to market a flu vaccine with a broader, more effective protection for all age groups.”

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