Tonix Pharmaceuticals Announces Licensing Agreement with Columbia University for the Development of Recombinant Trefoil Famil...
September 16 2019 - 4:15PM
Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the
Company), a clinical-stage biopharmaceutical company, today
announced that it has obtained an exclusive license from Columbia
University for the development of TNX-1700 (rTFF2) for the
treatment of gastric and pancreatic cancers. TNX-1700 is a biologic
currently in preclinical development. The licensed assets were
developed, in part, by Dr. Timothy C. Wang, Chief, Division of
Digestive and Liver Diseases, and Director of the Gastrointestinal
and Pancreas Cancer Program and Tumor Biology and Microenvironment
(TBM) program in the Herbert Irving Cancer Center at Columbia
University.
Tonix’s President and Chief Executive Officer, Seth Lederman,
M.D. said, “Tonix is excited to have in-licensed this technology to
bring into development. Dr. Wang is an expert in the molecular
mechanisms of carcinogenesis and for many years has studied the
carcinogenic role of inflammation in modulating stem cell
functions. These studies have led to fundamental insights on the
role of TFF2 at regulating this process and potentially using rTFF2
to make cancer cells susceptible to checkpoint inhibitors.”
Dr. Wang added, “Our research has demonstrated that knockout of
the TFF2 gene leads to faster tumor growth, while overexpression of
TFF2 markedly suppressed tumor growth by curtailing the
proliferation and expansion of myeloid progenitors that would
otherwise give rise to myeloid-derived suppressor cells. We believe
that the novel mechanism that allows activation of CD8+ T cells, by
limiting myeloid cells, may have implications for both cancer
prevention and cancer treatment. Furthermore, our modified version
of human TFF2 appears to show greater stability and efficacy than
native TFF2.”
About Trefoil Factor 2 (TFF2)
TFF2 is a small secreted protein, encoded by the TFF2 gene in
humans, that is expressed in gastrointestinal mucosa where it
functions to protect and repair mucosa. TFF2 is also expressed at
low levels in splenic immune cells and is now appreciated to have
intravascular roles in spleen and in the tumor microenvironment. In
gastric cancer, TFF2 is epigenetically silenced, and TFF2 is
suggested to be protective against cancer development through
several mechanisms.
Tonix Pharmaceuticals Holding Corp.
Tonix is a clinical-stage biopharmaceutical
company focused on discovering and developing small molecules and
biologics to treat psychiatric, pain and addiction conditions, to
improve biodefense through potential medical counter-measures and
to prevent and treat organ transplant rejection. Tonix’s lead
program is for the development of Tonmya* (TNX-102 SL), which is in
Phase 3 development as a bedtime treatment for PTSD. Tonix is also
developing TNX-102 SL as a bedtime treatment for fibromyalgia,
agitation in Alzheimer’s disease and alcohol use disorder, to be
developed under separate Investigational New Drug applications
(INDs) to support potential pivotal efficacy studies. The
fibromyalgia program is in Phase 3 development, the agitation in
Alzheimer’s program is Phase 2 ready and the alcohol use disorder
program is in the pre-IND application stage. TNX-1300**
(double-mutant cocaine esterase) is being developed under an IND
and is in Phase 2 development for the treatment of life-threatening
cocaine intoxication. Tonix has two other programs in the pre-IND
application stage of development for PTSD, but with different
mechanisms than TNX-102 SL and designed for daytime dosing: TNX-601
(tianeptine oxalate) and TNX-1600***, a triple reuptake inhibitor.
TNX-601 is also in development for a potential indication -
neurocognitive dysfunction associated with corticosteroid use. Data
is expected in the second half of 2019 for a Phase 1 clinical
formulation selection pharmacokinetic study of TNX-601 that is
being conducted outside of the U.S. TNX-801 (live virus vaccine for
percutaneous (scarification) administration) is a potential
smallpox-preventing vaccine based on a live synthetic version of
horsepox virus, currently in the pre-IND application stage.
Finally, TNX-1500 is being developed to prevent and treat organ
transplant rejection, as well as to treat autoimmune conditions,
and is in the pre-IND application stage.
*Tonmya has been conditionally accepted by the
U.S. Food and Drug Administration (FDA) as the proposed trade name
for TNX-102 SL for the treatment of PTSD. TNX-102 SL
(cyclobenzaprine HCl sublingual tablets) is an investigational new
drug and has not been approved for any indication.
**TNX-1300 (T172R/G173Q double-mutant cocaine
esterase 200 mg, i.v. solution) is an investigational new biologic
and has not been approved for any indication.
***TNX-1600
((2S,4R,5R)-5-(((2-aminobenzo[d]thiazol-6-yl)methyl)amino)-2-(bis(4-fluorophenyl)methyl)tetrahydro-2H-pyran-4-ol)
is an inhibitor of reuptake of three monoamine neurotransmitters
(serotonin, norepinephrine and dopamine), or a “triple
reuptake” inhibitor.
This press release and further information about
Tonix can be found at www.tonixpharma.com.
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; 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, 2018, as filed with the Securities and Exchange
Commission (the “SEC”) on March 18, 2019, and periodic reports on
Form 10-Q filed with the SEC on or after the date thereof. Tonix
does not undertake any obligation to update or revise any
forward-looking statements, whether as a result of new information,
future events or otherwise, except as required by law.
Contacts
Jessica Morris (corporate)Tonix
Pharmaceuticalsinvestor.relations@tonixpharma.com(212) 980-9159
Scott Stachowiak (media)Russo
Partnersscott.stachowiak@russopartnersllc.com (646) 942-5630
Peter Vozzo
(investors)Westwickepeter.vozzo@westwicke.com (443) 213-0505
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