Tonix Pharmaceuticals

Tonix Pharmaceuticals
Public
Traded as NASDAQ: TNXP
Industry Biotechnology
Healthcare
Headquarters New York, New York, United States
Key people
Website www.tonixpharma.com

Tonix Pharmaceuticals (Tonix Pharmaceuticals Holding Corp.) is a pharmaceutical company based in New York City that focuses on repurposed drugs for central nervous system conditions and as of 2016 was also pursuing a biodefense project.

The company's predecessors were Tamandare Explorations Inc. which had been formed in 2007 as a mining wildcat vehicle focused on land in Nevada and the shares of which were traded over the counter, and L & L Technologies, LLC, which had been formed in 1996 by Seth Lederman and Donald Landry to repurpose drugs for CNS development. L&L had formed Janus Pharmaceuticals, Inc., which later became Vela Pharmaceuticals, Inc. to develop some of its inventions, and Vela returned those assets to L&L in 2006. L&L placed them in a subsidiary called Krele Pharmaceuticals, Inc., and that subsidiary and Tamandare Explorations Inc. performed a reverse merger in October 2011; the new entity was renamed Tonix Pharmaceuticals Holding Corp. and Lederman was named CEO.[1] It was listed on the NASDAQ exchange in 2013 under the symbol TNXP.[1]

As of 2013 its lead candidates were a reformulation of cyclobenzaprine as a tablet for sublingual administration called TNX-102 SL (formerly called VLD-cyclobenzaprine and then KRL-102), which was under development for fibromyalgia and with preclinical efforts underway for posttraumatic stress disorder, TNX-201 (a single-racemate formulation of isometheptene mucate the company was considering for some headaches), and TNX-301, (a combination drug with disulfiram and selegiline for treatment for alcohol abuse).[1]

In September 2016 Tonix reported the failure of its Phase III trial of TNX-102 for fibromyalgia and said it was abandoning that line of development.[2][3]

Tonix continued work on TNX-102 SL in PTSD; the IND for that use had been accepted in 2014[4] and in December 2016 after the Phase IIa trial was done, TNX-102 was granted Breakthrough Therapy designation by the FDA.[5] It had entered Phase 3 development as of March 2017.[6]

In July 2017 the news division of the journal, Science, reported that Tonix had been sponsoring research and collaborating with scientists at the University of Alberta, David Evans and Ryan Noyce, and that the work had led to the generation of an extinct horsepox virus using synthetic biology — the lab had bought pieces of DNA from a reagent company and had built the horsepox genome with them. This dual-use research is controversial. This invention was licensed to Tonix and Tonix announced that it intended to further develop it into a smallpox vaccine, which is a biodefense business model.[7][8][9] The research was published in 2018.[10]

References

  1. 1 2 3 "Tonix Pharmaceuticals Holding Corp. Form S-1/A". SEC Edgar. August 8, 2013.
  2. ↑ "Tonix Ends Development of Lead Candidate for Fibromyalgia, but Continues PTSD Program". Genetic Engineering News. September 6, 2016.
  3. ↑ Banerjee, Ankur (September 6, 2016). "Tonix to stop testing drug for fibromyalgia, shares plunge". Reuters.
  4. ↑ Baum, Stephanie (Jun 23, 2014). "Tonix Pharmaceuticals developing treatment for underserved PTSD patients". MedCity News.
  5. ↑ Keshavan, Meghana (20 December 2016). "Can a muscle relaxant ease symptoms of PTSD?". STAT.
  6. ↑ "Cyclobenzaprine very low dose - Tonix Pharmaceuticals". AdisInsight. Retrieved 16 August 2017.
  7. ↑ Kupferschmidt, Kai (6 July 2017). "How Canadian researchers reconstituted an extinct poxvirus for $100,000 using mail-order DNA". Science.
  8. ↑ Achenbach, Joel; Sun, Lena H. (July 7, 2017). "Scientists synthesize smallpox cousin in ominous breakthrough". Washington Post.
  9. ↑ "Research programme: smallpox vaccines - Tonix Pharmaceuticals/University of Alberta". AdisInsight. Retrieved 16 August 2017.
  10. ↑ Noyce, Ryan S.; Lederman, Seth; Evans, David H. (January 19, 2018). "Construction of an infectious horsepox virus vaccine from chemically synthesized DNA fragments". PLOS One.
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