Tonix Pharmaceuticals Holding Corp. has entered into a sponsored research agreement with the Kenya Medical Research Institute (KEMRI) to design, plan, and seek regulatory approval for a Phase I clinical study of TNX-801 in Kenya. The study will evaluate the safety, tolerability, and immunogenicity of TNX-801 as a vaccine to prevent mpox and smallpox. Tonix will sponsor the trial, while KEMRI will oversee its execution.
TNX-801: A Potential Single-Dose Mpox Vaccine
TNX-801 is an attenuated live-virus vaccine candidate that has demonstrated efficacy against mpox in preclinical animal models. According to Seth Lederman, M.D., CEO of Tonix Pharmaceuticals, there is an urgent need for a single-dose mpox vaccine that provides durable protection. TNX-801 aligns with the World Health Organization's (WHO) preferred target product profile (TPP) for mpox vaccines, which includes single-dose administration, durable protection, ease of administration, and stability at ambient temperature.
Preclinical Efficacy and Safety
In animal studies, a single dose of TNX-801 protected against lethal challenge with intratracheal Clade Ia monkeypox virus, preventing clinical disease, skin lesions, and decreasing viral shedding in the mouth and lungs. These findings suggest that TNX-801 may induce mucosal immunity and block forward transmission. TNX-801 has also shown decreased virulence in immunocompromised animals compared to 20th-century vaccinia viruses, suggesting improved tolerability.
Addressing the Mpox Threat
The WHO has declared the mpox outbreak a public health emergency of international concern (PHEIC). The current outbreak is caused by the Clade Ib monkeypox virus, while the 2022 outbreak was caused by the Clade IIb monkeypox virus. The rapid spread of the Clade IIb strain in 2022, affecting over 90,000 people in non-endemic countries, highlights the pandemic potential of mpox. The Clade Ib strain is spreading in Africa, with a significant risk of appearing in the U.S., according to the CDC.
Manufacturing and Distribution
Tonix has partnered with Bilthoven Biologics (Bbio) to develop GMP manufacturing processes for TNX-801. Bbio is part of the Cyrus Poonawalla Group, which includes the Serum Institute of India, one of the world's largest vaccine manufacturers. This collaboration aims to ensure that TNX-801 can be scaled up for manufacturing, distribution, and storage without a costly supply chain.
