Tonix Pharmaceuticals Announces Results from a Preclinical Study of Murine TNX-1700 Presented in a Poster at the Keystone Symposia, “Cancer Immunotherapy: Mechanisms of Response Versus Resistance”
March 07 2023 - 07:00AM
GlobeNewswire Inc.
Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the
Company), a clinical-stage biopharmaceutical company, today
announced that preclinical results of mTNX-1700 (recombinant murine
TFF2-murine serum albumin, or MSA, fusion protein) were presented
in a poster at the Keystone Symposia, “Cancer Immunotherapy:
Mechanisms of Response Versus Resistance” on March 6, 2023, at the
Fairmont Banff Springs Conference Center
in Banff, Alberta, Canada. The poster can be found on
the Scientific Presentations page of Tonix’s website.
The poster, titled “TFF2-MSA Suppresses Tumor
Growth and Increases Survival in an anti-PD-1 Treated MC38
Colorectal Cancer Model by Targeting MDSCs,” includes data from
preclinical studies which evaluated the ability of mTNX-1700 to
treat colorectal cancer as monotherapy or in combination with
anti-PD-1 in mouse models. TNX-1700 targets myeloid-derived
suppressor cells (MDSCs) which interfere with the immune response
to cancer by suppressing the CD8+ T cell response and creating a
toxic tumor microenvironment. The data show that mTNX-1700 and
anti-PD-1 monotherapy each were able to evoke anti-tumor immunity
in the MC38 model of colorectal cancer, and that mTNX-1700
augmented the anti-tumor efficacy of anti-PD-1 therapy in two
different colorectal cancer models. Tonix is developing TNX-1700
(recombinant human TFF2-human serum albumin or HSA) for the
treatment of colon and gastric cancers.
“Anti-PD-1 treatment has revolutionized the
treatment of other cancers and is known as immuno-oncology,” said
Seth Lederman, M.D., Chief Executive Officer of Tonix. “Colorectal
cancer is notoriously unresponsive to anti-PD-1 treatment. Much
research has been focused on trying to turn anti-PD-1 unresponsive
tumors into anti-PD-1 responsive tumors.”
Bruce Daugherty, Ph.D., Executive Vice
President, Research of Tonix, the presenter and lead author of the
study added, “we believe that the data from these preclinical
studies demonstrate that mTNX-1700 treatment augmented the response
of two different models of colorectal tumors. In addition, it was
shown that mTNX-1700 inhibits the MDSCs which contribute to the
toxic element of the tumor microenvironment. Together these
findings support the idea that whether a tumor is anti-PD1
non-responsive or responsive may relate to the tumor
microenvironment rather than the tumor itself. We are excited to
start additional work to learn if TNX-1700 therapy modifies the
toxic tumor microenvironment in humans and will make colorectal
cancer responsive to anti-PD-1 therapy.”
About Trefoil Factor 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. Columbia was granted
patent claims, which, excluding possible patent term extensions, is
expected to provide U.S. market exclusivity until April 2,
20331,2. The inventor 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 cells3. 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.4 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 20205 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.
1Tonix 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 :: Tonix Pharmaceuticals Holding Corp.
(TNXP)2The U.S. Patent and Trademark Office issued U.S. Patent No.
11,167,010 on November 9, 2021.3Dubeykovskaya ZA et al, Nat Commun
20164Kim W et al, Gastroenterology 20215Tonix Pharmaceuticals
Announces Results from Preclinical Study of TNX-1700 Presented in a
Poster at AACR Virtual Annual Meeting 2020 :: Tonix Pharmaceuticals
Holding Corp. (TNXP)
Tonix Pharmaceuticals Holding
Corp.*
Tonix is a clinical-stage biopharmaceutical
company focused on discovering, licensing, acquiring and developing
therapeutics to treat and prevent human disease and alleviate
suffering. Tonix’s portfolio is composed of central nervous system
(CNS), rare disease, immunology and infectious disease product
candidates. Tonix’s CNS portfolio includes both small molecules and
biologics to treat pain, neurologic, psychiatric and addiction
conditions. Tonix’s lead CNS candidate, TNX-102 SL (cyclobenzaprine
HCl sublingual tablet), is in mid-Phase 3 development for the
management of fibromyalgia with a new Phase 3 study launched in the
second quarter of 2022 and interim data expected in the second
quarter of 2023. TNX-102 SL is also being developed to treat Long
COVID, a chronic post-acute COVID-19 condition. Tonix initiated a
Phase 2 study in Long COVID in the third quarter of 2022. 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 second quarter of 2023. TNX-1900 (intranasal potentiated
oxytocin), a small molecule in development for chronic migraine, is
being studied in a potential pivotal Phase 2 study that initiated
enrollment in the first quarter of 2023 and for which interim data
is expected in the fourth quarter of 2023. TNX-601 ER (tianeptine
hemioxalate extended-release tablets) is a once-daily formulation
of tianeptine being developed as a potential treatment for major
depressive disorder (MDD) with a Phase 2 study expected to be
initiated in the first quarter of 2023. Tonix’s rare disease
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 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 and xenograft rejection
and for the treatment of autoimmune diseases. A Phase 1 study of
TNX-1500 is expected to be initiated in the second quarter of 2023.
Tonix’s infectious disease pipeline includes a vaccine in
development to prevent smallpox and monkeypox, TNX-801; a
next-generation vaccine to prevent COVID-19, TNX-1850; a platform
to make fully human monoclonal antibodies to treat COVID-19,
TNX-3600; humanized anti-SARS-CoV-2 monoclonal antibodies,
TNX-3800; and a class of broad-spectrum small molecule oral
antivirals, TNX-3900. TNX-801, Tonix’s vaccine in development to
prevent smallpox and monkeypox, also serves as the live virus
vaccine platform or recombinant pox vaccine (RPV) platform for
other infectious diseases. A Phase 1 study of TNX-801 is expected
to be initiated in the second half of 2023.
*All of Tonix’s product candidates are
investigational new drugs or biologics and have not been approved
for any indication.
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; 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, 2021, as filed with the Securities and
Exchange Commission (the “SEC”) on March 14, 2022, 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.
Contacts
Jessica Morris (corporate)Tonix
Pharmaceuticalsinvestor.relations@tonixpharma.com(862) 904-8182
Olipriya Das, Ph.D. (media)Russo
PartnersOlipriya.Das@russopartnersllc.com (646) 942-5588
Peter Vozzo (investors)ICR
Westwickepeter.vozzo@westwicke.com(443) 213-0505
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