Tonix Pharmaceuticals Develops Vaccine with KEMRI

Tonix Pharmaceuticals has entered into a sponsored research agreement with the Kenya Medical Research Institute (KEMRI) to develop TNX-801, a live virus vaccine designed to prevent mpox and smallpox. This Phase I clinical study will evaluate the vaccine's safety, tolerability, and immunogenicity. The agreement reflects Tonix's commitment to addressing urgent global health needs, especially as TNX-801 aligns with the World Health Organization's preferred target product profile for mpox vaccines.

Seth Lederman, CEO of Tonix Pharmaceuticals, emphasized the critical need for a single-dose mpox vaccine that provides long-lasting protection. TNX-801 has demonstrated encouraging results in preclinical trials, and its formulation allows for easy scaling in manufacturing, distribution, and storage, minimizing supply chain complexities. This development is timely, given the recent outbreaks and the demand for effective vaccination solutions.

In a prior collaboration, Tonix partnered with Bilthoven Biologics to establish good manufacturing practices (GMP) for TNX-801. Bilthoven, part of the Cyrus Poonawalla Group, which includes the Serum Institute of India, brings significant expertise in vaccine production, positioning Tonix to rapidly advance its vaccine toward widespread availability. This strategic collaboration aims to facilitate a robust response to mpox and smallpox threats worldwide.