Tonix Pharmaceuticals

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 2020 was also pursuing a vaccine for COVID-19 and a biodefense project.[1]

Tonix Pharmaceuticals
TypePublic
NASDAQ: TNXP
IndustryBiotechnology
Healthcare
Headquarters
New York, New York
,
United States
Key people
Websitewww.tonixpharma.com

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.[2] It was listed on the NASDAQ exchange in 2013 under the symbol TNXP.[2]

The current lead candidates in the pipeline are the Phase 3 study of TNX-102 SL for the bedtime treatment of fibromyalgia, the Phase 2 study of TNX-1300 for cocaine intoxication and overdose and the preclinical study of TNX-1800, a potential coronavirus vaccine.[3]

In February 2020 Tonix began development of a potential vaccine to protect against COVID-19 with collaboration with Southern Research based on its live horsepox vaccine platform.[4] In May 2020 it announced an additional collaboration with the University of Alberta to develop more horsepox-based vaccines, TNX-1810, TNX-1820 and TNX-1830, partnering with FUJIFILM Diosynth Biotechnologies in College Station, TX, to manufacture the TNX-1800 vaccine candidate.[5]

In November 2019 Tonix announced the initiation of the Phase 3 study of TNX-102 SL for the management of fibromyalgia with interim analysis expected in September 2020 and topline data in the first quarter of 2021.[6] In January 2020, Tonix reported it has finished the essential fed-fasting and dose proportionality tests in support of a NDA.

Tonix continued work on TNX-102 SL in PTSD; the IND for that use had been accepted in 2014[7] and in December 2016 after the Phase IIa trial was done, TNX-102 was granted Breakthrough Therapy designation by the FDA in December 2017[8] which was rescinded in January 2019, but then restored in March 2019.[9] A Phase 3 trial of military-related PTSD began in February 2017, but was stopped in July 2018 after an interim analysis of 50% of target participants were evaluated, for "inadequate separation on primary efficacy endpoint".[10] In March 2020, a later Phase 3 trial of TNX-102 SL for PTSD in from mostly civilian traumas also showed futility at an interim analysis of 50% of its target participants patients were evaluated and enrollment was discontinued. FDA Breakthrough Therapy designation was rescinded again in May 2020.[11][12]

In July 2017 the news division of the journal, Science, reported that Tonix had sponsored 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 invention was licensed to Tonix and Tonix announced that it intended to further develop it into a smallpox vaccine, TNX-801, which is a biodefense business model.[13][14][15] The research was published in 2018.[16]

In May 2019, Tonix reported in-licensing the Phase 2 asset, TNX-1300 (T172R/G173Q double-mutant cocaine esterase 200 mg, i.v. solution), for the treatment of cocaine intoxication.[17][18] TNX-1300 (formerly known as RBP-8000) is being developed under an Investigational New Drug application (IND) for the treatment of cocaine intoxication.[19] TNX-1300 is a recombinant protein enzyme produced through rDNA technology in a non-disease-producing strain of E. coli bacteria. Cocaine Esterase (CocE) was identified in bacteria (Rhodococcus) that use cocaine as its sole source of carbon and nitrogen and that grow in soil surrounding coca plants.[20] The gene encoding CocE was identified and the protein was extensively characterized.[21][22][23] CoCE catalyzes the breakdown of cocaine into metabolite ecgonine methyl ester and benzoic acid. Wild-type CocE is unstable at body temperature, so targeted mutations were introduced in the CocE gene and resulted in the T172R/G173Q Double-Mutant CocE, which is active for approximately 6 hours at body temperature.[23] In a Phase 2 study, TNX-1300 at 100 mg or 200 mg i.v. doses was well tolerated and interrupted cocaine effects after cocaine 50 mg i.v. challenge.[19] TNX-1300 is designated as a breakthrough therapy by the U.S. Food and Drug Administration (FDA).

In September, 2019, Tonix licensed immuno-oncology treatment technology based on Trefoil Family Factor 2 (TFF2) from Columbia University.[24] A poster from that work was presented at the American Association of Cancer Research (AACR) meeting in June 2020.[25]

In December 2019, the Phase 1 trial for TNX-601 CR (tianeptine oxalate), an indirect glutamatergic pathway modulator, was completed and results were reported at the American Society of Clinical Psychopharmacology (ASCP) meeting in May 2020.[26]

In June 2020, Tonix acquired the migraine and pain treatment technologies of Trigemina for the TNX-1900 program based on a proprietary formulation of oxytocin.

References
  1. "What's special about Tonix Pharma and Southern Research's COVID-19 vac". www.thepharmaletter.com. Retrieved 2020-07-08.
  2. "Tonix Pharmaceuticals Holding Corp. Form S-1/A". SEC Edgar. August 8, 2013.
  3. [email protected], REBECCA FIEDLER. "College Station-based developers to manufacture clinical trial doses of COVID-19 vaccine". The Eagle. Retrieved 2020-07-08.
  4. "224-year-old Smallpox Treatment Modified for COVID-19 Candidate Vaccine". Technology Networks. Retrieved 2020-07-08.
  5. Oliver, Bill (2020-06-02). "B/CS Biocorridor Manufacturer Is Selected To Produce A Possible Coronavirus Vaccine". WTAW | 1620AM & 94.5FM. Retrieved 2020-07-08.
  6. "Tonix Pharmaceuticals Announces Initiation of the Phase 3 RELIEF Study of TNX-102 SL for the Management of Fibromyalgia". www.tonixpharma.com. Retrieved 2020-07-08.
  7. Baum S (Jun 23, 2014). "Tonix Pharmaceuticals developing treatment for underserved PTSD patients". MedCity News.
  8. Keshavan M (20 December 2016). "Can a muscle relaxant ease symptoms of PTSD?". STAT.
  9. "Tonix Pharmaceuticals Announces that Breakthrough Therapy Designation Remains in Effect for Tonmya® for the Treatment of Posttraumatic Stress Disorder". www.tonixpharma.com. Retrieved 2020-07-08.
  10. "Safety and Efficacy Study of TNX-102 SL in Patients With Military-related PTSD (HONOR)". ClinicalTrials.gov. 2018-09-17. Retrieved 2020-06-18.
  11. "Cyclobenzaprine very low dose - Tonix Pharmaceuticals". AdisInsight. Retrieved 16 August 2017.
  12. "10-K annual SEC report of Tonix Pharmaceuticals". Tonix Pharmaceuticals. 2020-03-24. Retrieved 2020-06-18. In PTSD, we are completing the Phase 3 RECOVERY trial and expect to report topline results in the second quarter of 2020, however, we cannot predict whether the global COVID-19 pandemic will impact the timing of topline results. Moreover, the RECOVERY study is unlikely to show an effect of TNX-102 SL, because at a pre-planned interim analysis in February of 2020, an Independent Data Monitoring Committee, or IDMC, reported that the drug effect, if any, was below the pre-specified criteria for futility, based on the results of the first 50% of enrolled participants. Based on the IDMC’s recommendation to stop the study, the RECOVERY study stopped enrolling new patients in February 2020.
  13. Kupferschmidt K (6 July 2017). "How Canadian researchers reconstituted an extinct poxvirus for $100,000 using mail-order DNA". Science.
  14. Achenbach J, Sun LH (July 7, 2017). "Scientists synthesize smallpox cousin in ominous breakthrough". Washington Post.
  15. "Research programme: smallpox vaccines - Tonix Pharmaceuticals/University of Alberta". AdisInsight. Retrieved 16 August 2017.
  16. Noyce RS, Lederman S, Evans DH (January 19, 2018). "Construction of an infectious horsepox virus vaccine from chemically synthesized DNA fragments". PLOS ONE. 13 (1): e0188453. Bibcode:2018PLoSO..1388453N. doi:10.1371/journal.pone.0188453. PMC 5774680. PMID 29351298.
  17. Collins T (2018), "Kicking against the pricks", How Football Began, Routledge, pp. 65–74, doi:10.4324/9781315177212-10, ISBN 9781315177212
  18. "Tonix boosts pipeline with Columbia University-developed cocaine intoxication drug". FierceBiotech. Retrieved 2019-05-28.
  19. Nasser AF, Fudala PJ, Zheng B, Liu Y, Heidbreder C (2014). "A randomized, double-blind, placebo-controlled trial of RBP-8000 in cocaine abusers: pharmacokinetic profile of rbp-8000 and cocaine and effects of RBP-8000 on cocaine-induced physiological effects". Journal of Addictive Diseases. 33 (4): 289–302. doi:10.1080/10550887.2014.969603. PMID 25299069.
  20. Bresler MM, Rosser SJ, Basran A, Bruce NC (March 2000). "Gene cloning and nucleotide sequencing and properties of a cocaine esterase from Rhodococcus sp. strain MB1". Applied and Environmental Microbiology. 66 (3): 904–8. doi:10.1128/aem.66.3.904-908.2000. PMC 91920. PMID 10698749.
  21. Larsen NA, Turner JM, Stevens J, Rosser SJ, Basran A, Lerner RA, Bruce NC, Wilson IA (January 2002). "Crystal structure of a bacterial cocaine esterase". Nature Structural Biology. 9 (1): 17–21. doi:10.1038/nsb742. PMID 11742345.
  22. Turner JM, Larsen NA, Basran A, Barbas CF, Bruce NC, Wilson IA, Lerner RA (October 2002). "Biochemical characterization and structural analysis of a highly proficient cocaine esterase". Biochemistry. 41 (41): 12297–307. doi:10.1021/bi026131p. PMID 12369817.
  23. Gao D, Narasimhan DL, Macdonald J, Brim R, Ko MC, Landry DW, Woods JH, Sunahara RK, Zhan CG (February 2009). "Thermostable variants of cocaine esterase for long-time protection against cocaine toxicity". Molecular Pharmacology. 75 (2): 318–23. doi:10.1124/mol.108.049486. PMC 2684895. PMID 18987161.
  24. "Tonix Pharmaceuticals Announces Licensing Agreement with Columbia University for the Development of Recombinant Trefoil Family Factor 2 (rTFF2), or TNX-1700, for the Treatment of Gastric and Pancreatic Cancers". www.tonixpharma.com. Retrieved 2020-07-08.
  25. "Tonix Pharmaceuticals Announces that Results from Preclinical Studies of TNX-1700 Will be Presented in a Poster at the AACR Virtual Annual Meeting 2020". AP NEWS. 2020-06-17. Retrieved 2020-07-08.
  26. "Tonix Pharmaceuticals Posted Results from Pharmacokinetic Analyses of TNX-102 SL and TNX-601 CR in Advance of Virtual Poster Presentations at the American Society of Clinical Psychopharmacology". www.tonixpharma.com. Retrieved 2020-07-08.
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