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news.Naobios and Tokyo Metropolitan Institute of Medical Science (TMIMS) have announced a partnership for the development of a new mpox vaccine using a live-attenuated approach.
The focus of this partnership is to create a vaccine based on a non-replicating highly attenuated vaccinia virus. Credit: Diana Polekhina on Unsplash.
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The focus of this partnership is to create a new vaccine utilising a non-replicating highly attenuated vaccinia virus, designed to enhance safety and reduce the risk of emergence of revertant pathogenic strains.
Mpox, which is also known as monkeypox, is a viral illness that primarily spreads through close contact with infected individuals, leading to symptoms such as fever, rash and lymph node enlargement. Severe cases may result in permanent scarring.
Two vaccines currently recommended by the World Health Organization are in use, one developed in the European Union, which is based on the Modified Vaccinia Virus Ankara (MVA) strain, and another in Japan, based on the LC16m8 strain.
The collaboration covers aseptic GMP and bioprocess production activities with downstream and upstream development using grade A in B suites.
Naobios managing director Eric Le Forestier said: “We are delighted to embark on this new project with TMIMS. Thanks to our recognised 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.”
Activities related to process development commenced this year and are scheduled to complete by the end of Q3 2025.
Manufacturing of a technical batch under GMP-like conditions will follow through late 2025 and into 2026, with GMP batch production for Phase I clinical trials expected to begin in mid-2026.
TMIMS-led clinical studies are planned for late 2026 and early 2027.
