Pipeline
: TNX-801 for Biodefense

TNX-801 for Biodefense

Brief Overview

Tonix's lead biological candidate, TNX-801, is a potential smallpox-preventing vaccine based on a live synthetic version of horsepox virus.

What makes TNX-801 unique?

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.

Development Status

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.

Basis for Exclusivity

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.

  1. Noyce RS, Lederman S, Evans DH. Construction of an infectious horsepox virus vaccine from chemically synthesized DNA fragments. PLoS One. 2018;13(1):e0188453.
  2. Engler RJ, Nelson MR, Collins LC, Jr., Spooner C, Hemann BA, Gibbs BT, Atwood JE, Howard RS, Chang AS, Cruser DL, Gates DG, Vernalis MN, Lengkeek MS, McClenathan BM, Jaffe AS, Cooper LT, Black S, Carlson C, Wilson C, Davis RL. A prospective study of the incidence of myocarditis/pericarditis and new onset cardiac symptoms following smallpox and influenza vaccination. PLoS One. 2015;10(3):e0118283.