Tonix Pharmaceuticals and KEMRI to Collaborate on Phase I TNX-801 Mpox Study in Kenya

Tonix Pharmaceuticals Holding Corp., a biopharmaceutical company, has announced a collaboration with the Kenya Medical Research Institute (KEMRI) to design and plan a Phase I clinical trial in Kenya. This trial is intended to evaluate the safety, tolerability, and immunogenicity of TNX-801, a horsepox-based live virus vaccine being developed to prevent mpox and smallpox. The study will be executed by KEMRI, while Tonix will sponsor the trial.

Seth Lederman, M.D., CEO of Tonix Pharmaceuticals, emphasized the importance of developing a single-dose mpox vaccine that offers durable protection. TNX-801 has shown promising preclinical data and aligns with the World Health Organization’s (WHO) target product profile (TPP) for mpox vaccines. This alignment includes characteristics such as single-dose administration, durable protection, and stability at ambient temperatures, making TNX-801 a potentially scalable and distributable vaccine without the need for a specialized supply chain.

Recent data from animal studies have shown that TNX-801 can offer immune protection against mpox, with better tolerability than 20th-century vaccinia viruses, which have become more virulent over time. TNX-801, designed to be similar to Edward Jenner's historic smallpox vaccine, has demonstrated efficacy in animal models where it protected against lethal challenges with the mpox virus, preventing clinical disease and reducing viral shedding. This suggests strong mucosal immunity and the potential to block transmission.

Tonix’s vaccine development for mpox is timely, given the WHO's declaration of mpox as a public health emergency of international concern (PHEIC). The ongoing mpox outbreaks, caused by different clades of the virus, have highlighted the urgent need for effective vaccines. The collaboration between Tonix and Bilthoven Biologics (Bbio) in August 2024 aims to develop Good Manufacturing Practice (GMP) manufacturing processes for TNX-801, bolstering its production capacity. Bbio is part of the Cyrus Poonawalla Group, which includes the Serum Institute of India, further supporting large-scale vaccine production capabilities.

Tonix Pharmaceuticals is a fully integrated biopharmaceutical company dedicated to addressing public health challenges and enhancing therapies for pain management. Its portfolio includes central nervous system (CNS) disorders, immunology, infectious diseases, and rare diseases. Among its CNS projects is TNX-102 SL, a candidate for managing fibromyalgia, which has received Fast Track designation from the FDA. Additionally, TNX-1300 is being developed to treat cocaine intoxication, supported by a grant and Breakthrough Therapy designation from the FDA.

In the field of immunology, Tonix is developing TNX-1500, a humanized monoclonal antibody targeting CD40-ligand for preventing organ transplant rejection and treating autoimmune diseases. For rare diseases, TNX-2900 is being developed to treat Prader-Willi syndrome. Tonix is also working on a broad-spectrum antiviral agent, TNX-4200, under a contract with the U.S. Department of Defense to enhance military personnel's readiness against biological threats.

Tonix's commercial subsidiary, Tonix Medicines, markets treatments for acute migraine, highlighting the company's broad focus across various therapeutic areas. Their commitment to addressing significant unmet medical needs is evident in their diverse and innovative development pipeline.