Tonix Pharmaceuticals Announces Data Presentations Involving TNX-1500 (anti-CD40L mAb) for the Prevention of Rejection in Kidney and Heart Allograft Transplantation in Animal Models at the 2023 American Transplant Congress
June 07 2023 - 07:00AM
Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the
Company), a clinical-stage biopharmaceutical company, today
announced data from two oral presentations and one poster
presentation at the 2023 American Transplant Congress (ATC) by
faculty at the Center for Transplantation Sciences, Massachusetts
General Hospital. The data involve studies of Tonix’s TNX-1500
(Fc-modified anti-CD40L monoclonal antibody) in development for the
prevention of organ transplant rejection. The molecular target of
TNX-1500 is CD40-ligand (CD40L), which is also known as CD154.
Copies of the presentations are available on the Tonix
Pharmaceuticals website at www.tonixpharma.com.
The oral presentations titled, “Fc-Modified
anti-CD154 Mab Induced Long Term Renal Allograft Survival without
Thromboembolic Complications” by Dr. Ryo Otsuka et al. and
“Efficacy of CD154 Blockade with TNX-1500 to prevent heart
allograft immune injury” by Dr. Ikechukwu Ileka et al., and the
poster presentation titled “anti-CD154 mAb (TNX-1500) Alone, or in
Combination with Rapamycin, MMF, or anti-CD28 mAb (VEL-101)
Prolongs Cynomolgus Cardiac Allograft Survival” by Dr. Kohei
Kinoshita et al. include data demonstrating that TNX-1500 showed
activity in preventing organ rejection and was well tolerated in
non-human primates. Blockade of CD40L with TNX-1500 monotherapy
consistently prevented pathologic alloimmunity in non-human primate
kidney and cardiac allograft models without clinical thrombosis.
Dr. Kinoshita was recognized with “Poster of Distinction” for his
poster presentation.
“The animal studies found that TNX-1500 retains
activity to prevent rejection and preserve graft function, which we
believe provides strong rationale for us to pursue development of
TNX-1500 to prevent rejection in human transplant,” said Seth
Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals.
“We expect to begin a Phase 1 trial with TNX-1500 in the third
quarter of 2023. There remains a significant need for new
treatments with improved activity and tolerability to prevent organ
transplant rejection. TNX-1500 is a third generation anti-CD40L mAb
that has been designed by protein engineering to decrease FcγRII
binding and to reduce the potential for thrombosis. We believe
TNX-1500 has the potential for treating and preventing organ
transplant rejection. Beyond transplantation, we believe TNX-1500
has potential for treating autoimmune conditions including systemic
lupus erythematosus, Sjögren’s syndrome and multiple
sclerosis.”
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 topline data expected in the fourth
quarter of 2023. TNX-102 SL is also being developed to treat Long
COVID, a chronic post-acute COVID-19 condition. Enrollment in a
Phase 2 study has been completed, and topline results are expected
in the third quarter of 2023. TNX-1900 (intranasal potentiated
oxytocin), in development for chronic migraine, is currently
enrolling with topline data expected in the fourth quarter of 2023.
TNX-601 ER (tianeptine hemioxalate extended-release tablets), a
once-daily formulation being developed as a treatment for major
depressive disorder (MDD), is also currently enrolling with interim
data expected in the fourth quarter of 2023. TNX-4300
(estianeptine) is a small molecule oral therapeutic in preclinical
development to treat MDD, Alzheimer’s disease and Parkinson’s
disease. 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 third 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 rejection and for the
treatment of autoimmune diseases. A Phase 1 study of TNX-1500 is
expected to be initiated in the third quarter of 2023. Tonix’s
infectious disease pipeline includes TNX-801, a vaccine in
development to prevent smallpox and mpox, for which a Phase 1 study
is expected to be initiated in the first quarter of 2024. TNX-801
also serves as the live virus vaccine platform or recombinant pox
vaccine platform for other infectious diseases. The infectious
disease portfolio also includes TNX-3900 and TNX-4000, classes of
broad-spectrum small molecule oral antivirals.
*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, 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.
Contacts
Jessica Morris (corporate)Tonix
Pharmaceuticalsinvestor.relations@tonixpharma.com(862) 904-8182
Maddie Stabinski (media)Russo
PartnersMadeline.Stabinski@russopartnersllc.com(212) 845-4273
Peter Vozzo
(investors)Westwicke/ICRpeter.vozzo@westwicke.com(443) 213-0505
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