Full Press Release Details
Tonix Pharmaceuticals Holding Corp. 8-K
Tonix Pharmaceuticals Acquires Exclusive
License to University of Geneva Technology for Oxytocin-Based Treatments for Treating Insulin Resistance, Diabetes and Obesity,
Expanding Proprietary Uses for TNX-1900 (Intranasal Potentiated Oxytocin)
University of Geneva Technology Covers Broad
Applications for Cardiometabolic Syndromes
CHATHAM, N.J., December 22, 2020 - Tonix Pharmaceuticals Holding
Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced an agreement whereby Tonix
has acquired the exclusive license to the University of Geneva's technology for using oxytocin to treat insulin resistance
and related syndromes, including obesity, from privately held Katana Pharmaceuticals, Inc. This license allows Tonix to expand
its intranasal potentiated oxytocin development program, TNX-1900, into cardiometabolic syndromes, which include insulin resistance,
impaired glucose tolerance, and obesity. The patents covering the technology are expected to provide Tonix with freedom to operate
in these indications as well as market exclusivity in the U.S. and Europe through 2031, upon its approval, independently of other
Tonix-held patents covering the formulation and potentiation technologies related to TNX-1900.
The University of Geneva technology is based
on the discovery that oxytocin administration in an animal model of obesity improved lipid metabolism by increasing lipolysis and
fatty acid- -oxidation in adipose tissue accompanied by improvements in glucose intolerance and insulin resistance, independent
"The important new technology from University of Geneva will
allow Tonix to develop intranasal oxytocin on a broader platform to treat both central nervous system (CNS) and cardiometabolic
conditions. We believe that TNX-1900 has the potential to be a safe, natural, non-addictive, and easy to administer treatment alternative
for a number of CNS disease states. Our lead indication for TNX-1900 is for the treatment of migraine," said Seth Lederman,
M.D., President and Chief Executive Officer of Tonix Pharmaceuticals.
"Subsequent to the University of Geneva inventions, a number
of studies have shown that intranasal oxytocin has effects on insulin resistance and weight2-4," continued Dr.
Lederman. "Intranasal oxytocin has been reported to improve glucose homeostasis,
improve pancreatic -cell responsivity, decrease energy-induced and reward-induced eating, and support cognitive control of
food choices.2-9 The effects of intranasal oxytocin on improving peripheral insulin sensitivity, pancreatic function
and lipid metabolism encourage us to develop TNX-1900 as a potential therapeutic in obesity, insulin resistance, diabetes management
and related metabolic complications."
In June 2020, Tonix acquired its potentiated oxytocin technology
and development program from Trigemina, Inc., and assumed licenses for certain related technologies from Stanford University. TNX-1900
has demonstrated activity in several non-clinical studies in CNS disease models. In addition, prior to the acquisition from Trigemina,
TNX-1900 was studied in the U.S. under a physician-requested Investigational New Drug Application.
1Deblon N, et al. (2011) PLoS ONE 6(9): e25565. doi:10.1371/journal.pone.0025565
Nat Rev Endocrinol. 13(12):700-709. doi: 10.1038/nrendo.2017.115. PMID: 28960210
et al. (2017) Curr Opin Endocrinol Diabetes Obes. 24(5):320-325. doi: 10.1097/MED.0000000000000351. PMID: 28590323.
(2019) Obes Rev. 2019 Jan;20(1):22-40. doi: 10.1111/obr.12757. PMID: 30253045.
5Lawson EA, et al. (2015) Obesity. 23:950-956.
DOI: 10.1002/oby.21069 PMID: 25865294
6Klement, J et al. (2017) Diabetes 66(2) 264-271; DOI: 10.2337/db16-0569
7Ott V, et al. (2013) Diabetes. 62:3418-3425.
DOI: 10.2337/db13-0663 PMID: 23835346
8Thienel M, et al. (2016) Int J Obes. 40(11):1707-1714.
DOI: 10.1038/ijo.2016.149 PMID:
9Striepens N, et al. (2016) Human Brain Mapp.
37(12):4276-4285. DOI: 10.1002/hbm.23308 PMID: 27381253
About TNX-1900 (Intranasal Potentiated Oxytocin)*
TNX-1900, Tonix's proprietary intranasal
oxytocin is currently being studied as a candidate for prophylaxis of chronic migraine. TNX-1900 is in the pre-Investigational
New Drug (IND) stage and has not been approved for any indication. It is based on a proprietary formulation of oxytocin and is
being developed first for the treatment of migraine. Oxytocin is a naturally-occurring human hormone that acts as a neurotransmitter
in the brain. It is approved by the U.S. Food and Drug Administration (FDA) as Pitocin , an intravenous infusion or intramuscular
injection drug, for use in pregnant women to induce labor. An intranasal form of oxytocin was marketed in the U.S. by Novartis
to assist in the production of breast milk as Syntocinon (oxytocin nasal 40 units/ml), but the product was withdrawn and the
New Drug Application (NDA) has been discontinued. In clinical and preliminary research, it has been observed that low oxytocin
levels in the body can lead to increase in headache frequency, and that increased oxytocin levels can relieve headaches. Oxytocin,
when delivered via the nasal route, results in enhanced binding of oxytocin to receptors on neurons in the trigeminal system, inhibiting
transmission of pain signals. Intranasal oxytocin has been well tolerated in several clinical trials in adults and children. Intranasal
oxytocin has been shown to block calcitonin gene-related peptide (CGRP) release in animals , a pathway known to be critical to
the pathogenesis of migraine attacks. TNX-1900 is believed to interrupt pain signals at the trigeminal ganglia by suppressing electrical
impulses, a potentially different activity than drugs that just block CGRP. Migraine attacks are caused, in part, by the release
of CGRP from pain-sensing nerve cells that are part of the trigeminal system. Targeted delivery results in low systemic exposure
and lower risk of non-nervous system, off-target effects which could potentially occur with systemic CGRP antagonists. For example,
CGRP has roles in dilating blood vessels in response to ischemia, including in the heart. Tonix believes targeted delivery of oxytocin
could translate into selective blockade of CGRP release in the trigeminal ganglion and not throughout the body, which could be
a potential safety advantage over systemic CGRP inhibition.
*TNX-1900 is in the pre-IND phase and has not been approved for
Pitocin is a trademark of Par Pharmaceutical,
Syntocinon is a trademark of BGP Products Operations GmbH
About Tonix Pharmaceuticals Holding Corp.
Tonix is a clinical-stage biopharmaceutical
company focused on discovering, licensing, acquiring and developing small molecules and biologics to treat and prevent human disease
and alleviate suffering. Tonix's portfolio is primarily composed of central nervous system (CNS) and immunology product candidates.
The CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions.
Tonix's lead CNS candidate, TNX-102 SL**, is in mid-Phase 3 development for the management of fibromyalgia since positive
data on the RELIEF Phase 3 trial were recently reported. The Company expects topline data for a 2nd Phase 3 study, RALLY,
in the fourth quarter of 2021. The immunology portfolio includes vaccines to prevent infectious diseases and biologics to address
immunosuppression, cancer, and autoimmune diseases. Tonix's lead vaccine candidate, TNX-1800***, is a live replicating vaccine
based on the horsepox viral vector platform to protect against COVID-19, primarily by eliciting a T cell response. Tonix expects
efficacy data from animal studies of TNX-1800 in the first quarter of 2021. TNX-801*, live horsepox virus vaccine for percutaneous
administration, is in development to protect against smallpox and monkeypox.
**TNX-102 SL is an investigational new drug and has not been approved
***TNX-1800 and TNX-801 are investigational new biologics and have
not been approved for any indication.
This press release and further information about Tonix can be found
Forward Looking Statements
Certain statements in this press release are
forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified
by the use of forward-looking words such as "anticipate," "believe," "forecast," "estimate,"
"expect," and "intend," among others. These forward-looking statements are based on Tonix's current expectations
and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from
those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to failure to
obtain FDA clearances or approvals and noncompliance with FDA regulations; delays and uncertainties caused by the global COVID-19
pandemic; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing;
uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research
and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development,
there are significant risks in the development, regulatory approval, and commercialization of new products. Tonix does not undertake
an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual
Report on Form 10-K for the year ended December 31, 2019, as filed with the Securities and Exchange Commission (the "SEC")