Tonix Pharmaceuticals announced in August 2024 that it is collaborating with Bilthoven Biologics (BBio) to advance TNX-801. TNX-801 is Tonix’s mpox vaccine candidate, a live replicating, attenuated virus vaccine based on horsepox. It has demonstrated better tolerability than 20th century vaccinia viruses in animal models, and preclinical studies have shown “positive” efficacy data.
TNX-801
Tonix’s TNX-801 is in preclinical development for the prevention of mpox and smallpox. In preclinical studies, Tonix found that TNX-801 vaccination protected non-human primates against lethal challenge, prevented clinical disease and lesions, and decreased shedding in the mouth and lungs. It is delivered percutaneously as a single dose, which could enable “higher rates of community protection”.
“TNX-801 has the potential to make a global impact on mpox and the risk of smallpox because of its durable T-cell immune response, the potential to manufacture at scale, and the use of a lower dose than non-replicating vaccines.”
Bolstering preparedness and response
Jurgen Kwik, Chief Executive Officer at Bilthoven Biologicals, believes that the current mpox outbreak “exemplifies precisely why we built the pandemic preparedness facility at BBio”.
“The establishment of the ‘ever-warm’ facility for pandemic preparedness underscores the critical importance of readiness in the face of global health emergencies, such as mpox. This collaboration encapsulates the essential role of the facility in bolstering pandemic preparedness and response capabilities.”
Dr Seth Lederman, Chief Executive Officer of Tonix Pharmaceuticals, looks forward to collaborating with BBio and “accelerating the development of our vaccine candidate to prevent mpox”. Dr Lederman believes that the single dose administration will “improve acceptance and eliminate partial vaccination” when compared to the current two-dose regimens.
“We believe TNX-801 can be rapidly scaled up for manufacturing and can be distributed and stored without a costly and cumbersome ultra-cold supply chain.”
Dr Lederman highlighted that the “worldwide availability of an affordable, safe, and effective single dose” vaccine against mpox is “essential given the pandemic potential of the disease”. Furthermore, successful development of TNX-801 would “establish the foundation” for potential expansion of the viral vector platform.
We look forward to learning more about this vaccine at the Congress in Barcelona this October; get your tickets to join us there and don’t forget to subscribe for more vaccine updates here.
