Tonix's lead biological candidate, TNX-801, is a potential smallpox-preventing vaccine based on a live synthetic version of horsepox virus.
TNX-801 is a novel, live virus vaccine grown in cell culture.1 Tonix is developing TNX-801 as a potential smallpox preventing vaccine for widespread immunization and national stockpile. Though it shares structural characteristics with vaccinia-based vaccines, TNX-801 has unique properties that Tonix believes it may lower toxicity and offer potential safety advantages over existing vaccinia-based vaccines, which have been associated with adverse side effects such as myocarditis/pericarditis.2
Being able to provide safe and effective smallpox-preventing vaccines remains important and necessary for addressing and protecting public health. Current vaccines have safety concerns,2 including cardiotoxicity, that limit their ability to protect U.S. Armed Forces, first responders or the public in case of need. A safer vaccine may allow for vaccine stockpiles with reduced risk of cardiotoxic reactions.
Tonix intends to meet with the FDA to discuss the most efficient and appropriate investigational plan, e.g., the application of the FDA Animal Efficacy Rule, or Animal Rule, or conducting active comparator studies using ACAM2000, the current licensed live vaccinia virus vaccine, to establish the safety and effectiveness to support the licensure TNX-801.
Recently a patent was filed on the TNX-801 novel virus vaccine to which Tonix has worldwide rights. In addition, Tonix expects 12 years of nonpatent-based exclusivity under the Patient Protection and Affordable Care Act.