(MENAFN- Andrew Lloyd & Associates) Naobios’ development work and GMP manufacturing of vaccine clinical batches enables FluGen to conduct its 2022 clinical trials in the United States
Nantes, France, June 21, 2022 – 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 it has successfully completed the development and GMP manufacturing of the clinical batch of M2SR influenza vaccine-candidate for FluGen, Inc., a clinical-stage vaccine company transforming vaccine efficacy in infectious respiratory diseases. This key milestone in the partnership will lead to the start, this month, of FluGen’s clinical trials 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 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.
“FluGen is very excited to start its upcoming clinical trial with the GMP clinical batch of M2SR manufactured by Naobios,” said Paul V. Radspinner, FluGen’s president and CEO. “Naobios has been an essential partner and we look forward to working with them as we continue to develop our vaccine candidates.”
“Naobios is extremely pleased to deliver its first GMP batch of M2SR vaccine to FluGen,” said Eric Le Forestier, general manager of Naobios. “This project has been successfully conducted under the very strict timelines required to initiate the clinical trials before the start of the flu season in the United States. 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.”
Influenza – at a glance
Influenza, also known as flu, is an acute viral infection characterized by the sudden onset of a high fever, cough, headache, muscle and joint pain, malaise and a runny nose - it typically lasts two to seven days. In the northern hemisphere, annual influenza epidemics occur during fall and winter, affecting approximately 5-15% of the population. The most effective way to prevent the disease or its severe outcomes is through vaccination.
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.
Naobios, a pharmaceutical production unit, joined the Clean Biologics group in 2019. It is a CDMO (Contract Development and Manufacturing Organization) providing bioprocess development and offering GMP production of clinical batches of viral vaccines BSL2/BSL3, oncolytic viruses and viral vectors.
Boasting 15 years’ experience in bioprocess development, Naobios helps its clients to bring their drug candidates to clinical stage as quickly as possible - to the highest level quality – whilst building on its technical know-how in scalable and industrial processes. With its adaptability and range of skills, and a motivated and dedicated team, the company can lead a project from the initial stages through to completion. Its highly qualified staff have the experience to deal with a wide range of sensitive viruses such as measles, SARS-CoV-2, polio and vaccinia, as well as various cell substrate lines.
Naobios is based near Nantes, in Western France; it currently has 40 staff.
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