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Naobios has stepped into the next stage in its collaboration with FluGen, a clinical-stage vaccine firm reshaping vaccine efficacy in infectious respiratory diseases.
FREMONT, CA: Naobios, a CDMO that provides bioprocess development and GMP production of clinical batches of viral vaccines BSL2/BSL3, oncolytic viruses, and viral vectors, has stepped into the next stage in its collaboration with FluGen, Inc., a clinical-stage vaccine firm that is reshaping vaccine efficacy in infectious respiratory diseases. In preparation for their future clinical trials in the United States, commencing in 2022, Naobios will begin GMP manufacturing of the clinical batches of FluGens M2SR influenza vaccine-candidate.
Naobios and FluGen have been working together to develop a scalable platform for FluGen's M2SR vaccine since 2019. A supra-seasonal, live, single-replication intranasal flu vaccine is the business's leading candidate. M2SR promotes mucosal, humoral, and cellular immunity, unlike regular flu vaccines.
"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 were looking forward to the manufacturing of this first GMP batch for FluGens 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."