Naobios and FluGen alliance continues: Production of intranasal flu vaccine clinical batches to get underway

By Jane Byrne

- Last updated on GMT

© GettyImages/DavidBGray
© GettyImages/DavidBGray

Related tags Influenza intranasal Vaccine

Naobios says its development work and GMP manufacturing of vaccine clinical batches will enable FluGen to prepare its 2022 clinical trials in the US.

Contract development and manufacturing organization (CDMO), Naobios, announced the next phase in its partnership with, FluGen, Inc; it will work with the US vaccine developer throughout the execution of clinical trials for its investigational intranasal M2SR flu vaccine.

Intranasal flu vaccine

The Wisconsin, US based 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, according to the developer.

The technology was first invented at the University of Wisconsin-Madison in the laboratories of Dr Yoshihiro Kawaoka and Dr Gabriele Neumann and exclusively licensed to FluGen. The M2SR vaccine contains vaccine viruses with a deletion in a portion of the M2 gene. “M2SR viruses can infect cells, express the entire spectrum of influenza RNA and proteins, yet cannot produce any infectious virus particles. Thus, the M2SR vaccines do not shed infectious virus and do not cause any pathological signs of infection. The M2SR viruses can be engineered to express the HA and neuraminidase antigens (NA) of any influenza virus and can be manufactured in cell lines that stably express the M2 protein.”

In a challenge trial, M2SR demonstrated protection against infection and illness across seven years of virus drift, said the developer, adding that M2SR can induce 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.”

Headquartered in Nantes, in western France, the CDMO provides bioprocess development and GMP production of clinical batches of viral vaccines BSL2/BSL3, oncolytic viruses and viral vectors, with capabilities to deliver batches for clinical programs up to Phase 3.

Since 2019, Naobios and FluGen have collaborated on the process development of a scalable platform for FluGen’s M2SR vaccine.

Cell-based manufacturing of influenza vaccines has long been a vexing challenge for the industry, noted Naobios.

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. This will take place as we continue with parallel scale-up for additional influenza strains,”​ said Eric Le Forestier, general manager of the CDMO, which is part of the Clean Biologics group. 

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