NANTES, France & TOKYO–(BUSINESS WIRE)–Naobios, a CDMO providing bioprocess development and GMP production of clinical batches of virus-based products, and the Tokyo Metropolitan Institute of Medical Science (TMIMS), today announce their collaboration for the development of a new mpox vaccine using a live-attenuated vaccine.
Mpox is a viral illness caused by the monkeypox virus. It spreads mainly through close contact with an infected person, causing a painful rash, enlarged lymph nodes and fever.
A global outbreak began in 2022 and as of March 2025, it has spread to 130 countries, infecting close to 130.000 people and causing more than 280 deaths. Currently two mpox vaccines recommended by the WHO are in use:
- One developed in the EU based on the Modified vaccinia virus Ankara (MVA) strain
- One developed in Japan based on the LC16m8 strain
This collaboration aims to develop a new vaccine based on a non-replicating highly attenuated vaccinia virus in most of mammalian cells. This is of interest due to the extremely low possibility of seeing the emergence of a revertant strain that has mutated and is pathogenic to humans, which ensures a high level of safety.
This partnership with TMIMS is a full project with process development activities, upstream and downstream development and aseptic GMP production activities using grade A in B suites.
“We are delighted to embark on this new project with TMIMS,” said Eric Le Forestier, Managing Director of Naobios. “Thanks to our recognized know-how and capabilities in the full development of the bioprocesses involved in the manufacture of viral-based products, paired with TMIMS expertise, we are fully equipped to bring this project forward efficiently.”
The process development activities started this year and should be completed by end of Q3, 2025. For the rest of 2025 and into 2026, the partners will work on manufacturing the first technical batch, mimicking GMP conditions. The production of the GMP batch for phase I clinical trials will take place in mid-2026. The clinical studies spearheaded by TMIMS are planned for the end of 2026 and the beginning of 2027.
About Naobios
Naobios is a CDMO providing bioprocess development and offering GMP production of clinical batches of BSL2/BSL3 viral vaccines, oncolytic viruses, challenge agents, viral vectors and exosomes. Naobios joined the Clean Biologics group in 2019.
www.naobios.com
Contacts
Céline Gonzalez
[email protected]
