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Naobios and FluGen begin collaboration to optimize manufacturing process for M2SR quadrivalent influenza vaccine
Naobios is announcing today that it has started the process optimization for a quadrivalent version of FluGen’s M2SR influenza vaccine.
Naobios previously performed process development and cGMP manufacturing of FluGen’s monovalent M2SR vaccine for a recently completed clinical trial.
“Our team is very proud of what has been achieved so far”, said Eric Le Forestier, Naobios General Manager. “The manufacturing in 9 months of FluGen’s Drug Product was a challenge we achieved thanks to the excellent collaboration between our teams. Naobios is extremely motivated to start this next phase of the project. The activities initiated will test state-of-the-art technologies to further improve the process performance and reach industrial requirements. We are very pleased to be a trusted partner and to provide continued support for the development of FluGen’s innovative vaccine and influenza vector platform program.”
“FluGen is excited to advance the quadrivalent influenza formulation of our M2SR platform with Naobios. We have shown excellent clinical results with our monovalent M2SR and this work will allow us to demonstrate clinical results with the version that will ultimately go to market and prevent millions of people from being infected with influenza” said Paul Radspinner, FluGen CEO. “Naobios has been and will continue to be an incredibly valuable partner as we navigate this important milestone in FluGen’s history.”
About FluGen:
FluGen, Inc. is a clinical-stage vaccine company, transforming vaccine efficacy in respiratory diseases. The company’s lead candidate is M2SR, a supra-seasonal, live, single-replication, intranasal flu vaccine. Unlike standard of care flu vaccines, M2SR stimulates mucosal, humoral and cellular immunity. In an unprecedented challenge trial, M2SR demonstrated protection against infection and illness across seven years of virus drift; M2SR induces a durable antibody response with potential to cover an entire flu season and beyond. M2SR has also shown activity as a vaccine vector for other respiratory vaccines and infectious diseases, including a covid-19/flu combination
FluGen is based in Madison (Wisconsin) in the United States.
About Naobios:
Naobios is a Contract Development and Manufacturing Organization (CDMO) providing bioprocess development and offering GMP production of clinical batches of viral vaccines BSL2/BSL3, oncolytic viruses, viral vectors and challenge agents. Naobios joined the Clean Biologics group in 2019.
Boasting 15 years of experience in bioprocess development, Naobios helps its clients to bring their drug candidates to clinical stage as rapidly as possible – with the highest quality level – 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 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.
Naobios is based near Nantes, in Western France. It currently has 40 employees.