Shares of Tonix Pharmaceuticals Holding (NASDAQ: TNXP) gained 4% this morning as the company, along with researchers from the University of Alberta, announced the successful synthesis of a potential smallpox-preventing vaccine. The vaccine candidate, TNX-801, is a live form of horsepox virus (HPXV) that has demonstrated protective vaccine activity in mice. HPXV was synthesized at the University of Alberta, with Dr. Lederman as co-investigator of the research and co-inventor of the TNX-801 patent. Per the research and development agreement, Tonix wholly owns the synthesized HPXV virus stock and related sequences. Tonix has initiated vaccine manufacturing activities to support further nonclinical testing of TNX-801. The vaccine may qualify for a priority review voucher if it is approved by the FDA under provisions in the 21st Century Cures Act. “Presently, the safety concern of existing smallpox-preventing vaccines outweigh the potential benefit to provide immunization of first responders or the general public. By developing TNX-801 as a horsepox vaccine to prevent smallpox infection, we hope to have a safer vaccine to protect against smallpox than is currently available,” Tonix president and CEO Seth Lederman, M.D. stated in the news release.
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About Tonix Pharmaceuticals Holding Corp.
Tonix is developing innovative pharmaceutical products to address public health challenges, with TNX-102 SL in phase 3 development for posttraumatic stress disorder (PTSD). TNX-102 SL is designed for bedtime use and is believed to improve overall PTSD symptoms by improving sleep quality in PTSD patients. PTSD is a serious condition characterized by chronic disability, inadequate treatment options especially for military-related PTSD and overall high utilization of healthcare services creating significant economic burden. TNX-102 SL was recently granted Breakthrough Therapy designation by the FDA for the treatment of PTSD. Other development efforts include TNX-601, a clinical candidate at Pre-IND (Investigational New Drug) application stage, designed for daytime use for the treatment of PTSD, and TNX-801, a potential smallpox-preventing vaccine. TNX-102 SL (cyclobenzaprine HCl sublingual tablets) is an investigational new drug and has not been approved for any indication. For more information, visit www.tonixpharma.com.
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