Tonix Pharma Unveils Vaccine Platform Data at Vaccine Congress 2024

Tonix Pharmaceuticals, Inc., a fully-integrated biopharmaceutical company, recently showcased its advancements in vaccine development at the Vaccine Congress 2024 in Prague, Czech Republic. The focus was primarily on the company's innovative live virus vaccines, TNX-801 and TNX-1800, targeting mpox, smallpox, and COVID-19.

TNX-801, a live virus vaccine based on horsepox, aims to provide long-term protection from both mpox and smallpox with a single dose. Preclinical studies demonstrated its efficacy in safeguarding non-human primates from lethal challenges with intratracheal Clade I monkeypox virus. The vaccine not only prevented clinical disease and lesions but also significantly reduced viral shedding in the mouth and lungs, indicating robust mucosal immunity. This suggests a potential to block forward transmission, reminiscent of Dr. Edward Jenner’s vaccinia vaccine, which eradicated smallpox and kept mpox at bay.

TNX-1800 is another live attenuated vaccine based on horsepox but engineered to express the SARS-CoV-2 spike protein to combat COVID-19. This vaccine has been selected by the U.S. National Institute of Health (NIH) for Project NextGen, a program aimed at identifying promising next-generation COVID-19 vaccine candidates. The NIH plans to conduct a Phase 1 clinical trial for TNX-1800, covering all associated costs while Tonix supplies the vaccine.

Tonix's presentation also highlighted the global mpox outbreak that began in 2022, affecting over 90,000 individuals in regions where mpox was not previously endemic, including Europe and the U.S. The outbreak featured the Clade IIb strain, which demonstrated significant pandemic potential. In contrast, the Clade I strain remains endemic in Central African countries like the Democratic Republic of the Congo and is associated with higher fatality rates. The possibility of the more virulent Clade I strain reaching the U.S. poses a serious threat, emphasized by agencies such as the U.S. Centers for Disease Control and Prevention (CDC).

Furthermore, the presentation referenced recent discussions by the Bipartisan Commission on Biodefense and the National Academies of Science, which stressed the need for new single-dose vaccines for smallpox and highlighted the risks of smallpox reintroduction either through laboratory accidents or bioterrorism.

Tonix's CEO, Dr. Seth Lederman, expressed optimism about the company's vaccine platform, noting its potential for rapid manufacturing and distribution without the need for an ultra-cold supply chain. This characteristic is particularly advantageous for global vaccine deployment. Beyond TNX-801 and TNX-1800, Tonix is exploring the use of its live virus vaccine platform to develop other recombinant vaccines for a range of infectious diseases.

Tonix Pharmaceuticals continues to focus on its extensive pipeline of development candidates, addressing central nervous system (CNS) disorders, immunology, and infectious diseases. Among its CNS candidates, TNX-102 SL is being developed for fibromyalgia and Long COVID, while TNX-1300 targets cocaine intoxication. In the field of immunology, TNX-1500, a humanized monoclonal antibody, is in development to prevent organ transplant rejection and treat autoimmune diseases.

In addition to its development projects, Tonix's commercial subsidiary markets products for acute migraine treatment, including Zembrace SymTouch and Tosymra.

Tonix remains committed to advancing its diverse portfolio of therapeutic candidates and addressing unmet medical needs across various domains of human health.