Tonix Pharmaceuticals Presents New Preclinical Data at Seventh International Cancer Immunotherapy Conference 2023
21 Setembro 2023 - 8:00AM
Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a
biopharmaceutical company with marketed products and a pipeline of
development candidates, today announced a poster presentation
showing research results for mTNX-1700 (murine trefoil factor
family member 2- murine serum albumin, or mTFF2-MSA) at the Seventh
International Cancer Immunotherapy Conference 2023 (CICON23):
Translating Science into Survival, being held September 20-23,
2023, in Milan, Italy. The poster is available under the Scientific
Presentations tab of the Tonix website at www.tonixpharma.com.
The poster presentation, titled, “mTFF2-MSA
(mTNX-1700) Suppresses Tumor Growth and Increases Survival in
Anti-PD-1 Treated CT26.WT Subcutaneous and CT26-Luciferase
Orthotopic Syngeneic Colorectal Cancer Models by Targeting MDSCs in
BALB/C Mice,” includes data demonstrating that the novel fusion
protein, mTNX-1700 has single agent activity and can improve on the
therapeutic effects of anti-PD-1 in treating syngeneic mouse models
of advanced colorectal cancer. In two models, mTNX-1700 increases
survival rates and suppresses tumor growth. Additive tumor growth
suppression effects were observed when mTNX-1700 and anti-PD-1 were
used in combination.
“mTNX-1700 is a novel fusion protein that has
single agent activity and augments PD-1 blockade therapy in
combination therapy in advanced and metastatic syngeneic mouse
models of colorectal and gastric cancer,” said Seth Lederman, M.D.,
Chief Executive Officer of Tonix Pharmaceuticals. “Certain cancers
are unresponsive to anti-PD-1 therapy. Despite the significance of
PD-1 checkpoint blockade in treating many types of cancer, there’s
a need to better understand why some cancers don’t respond and how
to make them responsive. We believe these data show the potential
of TNX-1700 in treating cancer both as a single agent and in
combination with other immuno-oncology drugs, particularly
anti-PD-1, and highlight how mTNX-1700 targets MDSCs as a novel
mechanism to treat cancer.”
About Trefoil Factor Family Member 2
(TFF2)
Human TFF2 is a 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 the 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 is developing
TNX-1700 (rTFF2-HSA) for the treatment of gastric and colon cancers
under a license from Columbia University. The inventor of the core
technology at Columbia is Dr. Timothy Wang, who is an expert in the
molecular mechanisms of carcinogenesis whose research has focused
on the carcinogenic role of inflammation in modulating stem cell
functions. Dr. Wang demonstrated that knocking out the mTFF2 gene
in mice leads to faster tumor growth and that overexpression of
TFF2 markedly suppresses tumor growth by curtailing the homing,
differentiation, and expansion of MDSCs to allow activation of
cancer-killing CD8+ T cells.1 He went on to show that a novel
engineered form of recombinant murine TFF2 (mTFF2-CTP) had an
extended half-life in vivo and was able to suppress MDSCs
and tumor growth in an animal model of colorectal cancer. Later, he
showed in gastric cancer models that suppressing MDSCs using
chemotherapy enhances the effectiveness of anti-PD1 therapy and
significantly reduces tumor growth.2 Dr. Wang proposed the
concept of employing rTFF2 in combination with other therapies in
cancer prevention and early treatment. Dr. Wang presented data at
the American Association for Cancer Research (AACR) conference as a
collaboration between Tonix and Columbia University in
2020 that includes data from a preclinical study which
investigated the role of PD-L1 in colorectal tumorigenesis and
evaluated the utility of targeting myeloid-derived suppressor cells
(MDSCs) in combination with PD-1 blockade in mouse models of
colorectal cancer. The data show that anti-PD-1 monotherapy was
unable to evoke anti-tumor immunity in this model of colorectal
cancer, but mTFF2-CTP augmented the efficacy of anti-PD-1 therapy.
Anti-PD-1 in combination with TFF2-CTP showed greater anti-tumor
activity in PD-L1-overexpressing mice. 1Dubeykovskaya ZA et al, Nat
Commun 20162Kim W et al, Gastroenterology 2021
Tonix Pharmaceuticals Holding
Corp.*
Tonix is a biopharmaceutical company focused on
commercializing, developing, discovering and licensing therapeutics
to treat and prevent human disease and alleviate suffering. Tonix
Medicines, our commercial subsidiary, markets Zembrace® SymTouch®
(sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray)
10 mg under a transition services agreement with Upsher-Smith
Laboratories, LLC from whom the products were acquired on June 30,
2023. Zembrace SymTouch and Tosymra are each indicated for the
treatment of acute migraine with or without aura in adults. Tonix’s
development portfolio is composed of central nervous system (CNS),
rare disease, immunology and infectious disease product candidates.
Tonix’s CNS development portfolio includes both small molecules and
biologics to treat pain, neurologic, psychiatric and addiction
conditions. Tonix’s lead development CNS candidate, TNX-102 SL
(cyclobenzaprine HCl sublingual tablet), is in mid-Phase 3
development for the management of fibromyalgia, having completed
enrollment of a potentially confirmatory Phase 3 study in the third
quarter of 2023, with topline data expected in the fourth quarter
of 2023. TNX-102 SL is also being developed to treat
fibromyalgia-type Long COVID, a chronic post-acute COVID-19
condition. Enrollment in a Phase 2 proof-of-concept study has been
completed, and topline results were reported in the third quarter
of 2023. TNX-601 ER (tianeptine hemioxalate extended-release
tablets) is a once-daily oral formulation being developed as a
treatment for major depressive disorder (MDD), that completed
enrollment in a Phase 2 proof-of-concept study in the third quarter
of 2023, with topline results expected in the fourth quarter of
2023. TNX-4300 (estianeptine) is a single isomer version of
TNX-601, small molecule oral therapeutic in preclinical development
to treat MDD, Alzheimer’s disease and Parkinson’s disease. Relative
to tianeptine, estianeptine lacks activity on the µ-opioid receptor
while maintaining activity in the rat Novel Object Recognition test
in vivo and the ability to activate PPAR-β/δ and neuroplasticity in
tissue culture. TNX-1900 (intranasal potentiated oxytocin), is in
development for preventing headaches in chronic migraine, and has
completed enrollment in a Phase 2 proof-of-concept study with
topline data expected in the fourth quarter of 2023. TNX-1900 is
also being studied in binge eating disorder, pediatric obesity and
social anxiety disorder by academic collaborators under
investigator-initiated INDs. TNX-1300 (cocaine esterase) is a
biologic designed to treat cocaine intoxication and has been
granted Breakthrough Therapy designation by the FDA. A Phase 2
study of TNX-1300 is expected to be initiated in the fourthquarter
of 2023. Tonix’s rare disease development portfolio includes
TNX-2900 (intranasal potentiated oxytocin) for the treatment of
Prader-Willi syndrome. TNX-2900 has been granted Orphan Drug
designation by the FDA. Tonix’s immunology development portfolio
includes biologics to address organ transplant rejection,
autoimmunity and cancer, including TNX-1500, which is a humanized
monoclonal antibody targeting CD40-ligand (CD40L or CD154) being
developed for the prevention of allograft rejection and for the
treatment of autoimmune diseases. A Phase 1 study of TNX-1500 was
initiated in the third quarter of 2023. Tonix’s infectious disease
pipeline includes TNX-801, a vaccine in development to prevent
smallpox and mpox. TNX-801 also serves as the live virus vaccine
platform or recombinant pox vaccine platform for other infectious
diseases. The infectious disease development portfolio also
includes TNX-3900 and TNX-4000, which are classes of broad-spectrum
small molecule oral antivirals.
*Tonix’s product development candidates are
investigational new drugs or biologics and have not been approved
for any indication.
Zembrace SymTouch and Tosymra are registered
trademarks of Tonix Medicines. Intravail is a registered trademark
of Aegis Therapeutics, LLC, a wholly owned subsidiary of Neurelis,
Inc. All other marks are property of their respective owners.
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 the failure to obtain FDA clearances or approvals and
noncompliance with FDA regulations; risks related to the failure to
successfully market any of our products; 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, 2022, as filed
with the Securities and Exchange Commission (the “SEC”) on March
13, 2023, and periodic reports filed with the SEC on or after the
date thereof. All of Tonix's forward-looking statements are
expressly qualified by all such risk factors and other cautionary
statements. The information set forth herein speaks only as of the
date thereof.
Investor Contact
Jessica MorrisTonix
Pharmaceuticalsinvestor.relations@tonixpharma.com (862)
904-8182
Peter VozzoICR Westwickepeter.vozzo@westwicke.com (443)
213-0505
Media Contact
Ben ShannonICR Westwickeben.shannon@westwicke.com(919)
360-3039
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