TNX-801 (live virus vaccine) for Smallpox Prevention
TNX-801 is a novel, live virus vaccine grown in cell culture. 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 may suggest lower toxicity and potential safety advantages over existing vaccinia-based vaccines, which have been associated with adverse side effects such as myopericarditis.
Tonix intends to develop TNX-801 under 21 CFR 601 Subpart H, pursuant to which the FDA may grant marketing approval for a biological product for which safety has been established in humans and for which the requirements for efficacy are met based on adequate and well-controlled animal studies, where human studies are not ethical or feasible. This approval pathway has been described as the “Animal Rule”.
In the 1970s, vaccination against smallpox was discontinued in the U.S.; however, smallpox remains a material threat to national security. Recently, a patent was filed on the novel virus vaccine to which Tonix has worldwide rights. In addition, Tonix expects 12 years of non-patent based exclusivity under the Patient Protection and Affordable Care Act.
Following the recent passage of the 21st Century Cures Act, Tonix believes TNX-801 qualifies as a medical countermeasure (MCM), and therefore should be eligible for a Priority Review Voucher (PRV) upon FDA approval. Currently, Tonix is working to develop a good manufacturing practice (GMP)-quality vaccine to support an investigational new drug application.