Tonix Pharma Presented Mpox Vaccine Data at World Vaccine Congress-Europe 2024

Tonix Pharmaceuticals Holding Corp., a clinical-stage biopharmaceutical company, recently revealed promising data for its investigational vaccine, TNX-801, at the World Vaccine Congress-Europe 2024 in Barcelona. The presentation highlighted the vaccine's robust preclinical efficacy and tolerability, particularly in immunocompromised animal models. TNX-801, based on a synthesized horsepox virus, is designed as a single-dose, minimally replicating live-virus vaccine for mpox (monkeypox).

The new data demonstrated that even at doses 100 times higher than traditional vaccinia vaccines, TNX-801 did not spread to blood or tissues in immunocompromised animals. This is a significant finding, showcasing the vaccine's safety profile. Moreover, TNX-801 provided effective protection against lethal challenges from clade I monkeypox, preventing clinical disease and reducing viral shedding in the mouth and lungs. These results suggest that the vaccine induces mucosal immunity and has the potential to prevent the forward transmission of the virus.

Tonix's CEO, Seth Lederman, emphasized the importance of synthetic biology in the development of vaccines, especially as viral diseases continue to evolve. He pointed out that TNX-801's favorable characteristics, including its strong efficacy and tolerability, make it a promising candidate for addressing mpox outbreaks. The vaccine aligns with the World Health Organization's (WHO) preferred target product profile for mpox vaccines, which includes single-dose administration, durability, ease of use without special equipment, and stability at ambient temperatures.

In response to the mpox public health emergency declared by the WHO, Tonix is actively developing TNX-801 to meet global needs. The recent outbreak of clade I mpox, which started in the Democratic Republic of the Congo, has spread to numerous countries, including Sweden, Thailand, Singapore, India, Germany, and England. There is also a significant risk of the clade I strain appearing in the United States, according to the Centers for Disease Control and Prevention (CDC).

Tonix has also announced a collaboration with Bilthoven Biologics to develop Good Manufacturing Practice (GMP) processes for TNX-801. Bilthoven Biologics is part of the Cyrus Poonawalla Group, the world's largest vaccine manufacturer, which includes the Serum Institute of India. This partnership aims to ensure the scalable and reliable production of the vaccine.

In addition to TNX-801, Tonix is working on other vaccine candidates, including TNX-1800, which is based on the horsepox platform and designed to protect against COVID-19 by expressing the SARS-CoV-2 spike protein. Preclinical studies have shown that TNX-1800 induces a strong neutralizing antibody response and significantly reduces virus replication in the respiratory tract.

Tonix Pharmaceuticals remains dedicated to advancing its pipeline of products aimed at addressing various public health challenges. The company's portfolio includes treatments for central nervous system disorders, pain management, and infectious diseases. Among its notable projects is TNX-102 SL for fibromyalgia, which has received Fast Track designation from the FDA. Tonix is also developing TNX-1300 for cocaine intoxication, supported by a grant from the U.S. National Institute on Drug Abuse, and TNX-1500 for preventing organ transplant rejection and treating autoimmune diseases.

In August 2024, the WHO determined that the spread of clade I mpox constituted a public health emergency of international concern. This declaration underscores the urgent need for effective vaccines like TNX-801. The global impact of mpox, which has affected over 90,000 people since the 2022 outbreak, highlights the critical role of innovative vaccine solutions in controlling the disease and preventing further spread. Tonix's ongoing efforts to develop and manufacture TNX-801 represent a significant step towards addressing this public health threat.