Naobios’ development work and GMP manufacturing of vaccine clinical batches enables FluGen to conduct its 2022 clinical trials in the United States.
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, singlereplication, 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.