Tonix Pharmaceuticals Announces Data Presentations Involving TNX-1500 (Fc-Modified Anti-CD40L mAb) for the Prevention of Rejection in Allograft and Xenograft Transplantation in Animal Models at the International Congress of The Transplantation Society (TTS
September 15 2022 - 7:00AM
Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the
Company), a clinical-stage biopharmaceutical company, today
announced data from three oral presentations by faculty at the
Center for Transplantation Sciences, Massachusetts General Hospital
Center at the 29th International Congress of The Transplantation
Society (TTS 2022) held September 10-14, 2022 in Buenos Aires,
Argentina. The data involve studies of Tonix’s TNX-1500 (Fc
modified anti-CD40L monoclonal antibody) product candidate 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 under the
Scientific Presentations tab of the Tonix website at
www.tonixpharma.com.
The presentations titled, “Long-term
rejection-free renal allograft survival with Fc-modified anti-CD154
antibody monotherapy in nonhuman primates,” and “Monotherapy with
TNX-1500, a Fc-modified anti-CD154mAb, prolongs cardiac allograft
survival in cynomolgus monkeys,” include data demonstrating that
TNX-1500 treatment showed activity in preventing organ rejection
and was well tolerated in non-human primates. Blockade of CD40L
with TNX-1500 monotherapy consistently and safely prevented
pathologic alloimmunity in non-human primate cardiac and kidney
allograft models without clinical thrombosis.
The presentation titled, “Long-term (>1 year)
rejection-free survival of kidney xenografts with triple
xenoantigen knockout and multiple human transgenes in nonhuman
primates,” includes data demonstrating that TNX-1500 treatment
showed activity in preventing xenograft kidney rejection and was
well tolerated in non-human primates. Xenografts are transplanted
organs from donors of a different species from the recipient, and
in this study, the xenografts originated from genetically
engineered pigs. Blockade of CD40L with TNX-1500 monotherapy
consistently and safely prevented pathologic xenoimmunity in
non-human primate kidney xenograft models without clinical
thrombosis.
“There remains a significant need for new
treatments with improved activity and tolerability to prevent organ
transplant rejection,” said Seth Lederman, M.D., Chief Executive
Officer of Tonix Pharmaceuticals. “To date, there has not been a
humanized anti-CD40L antibody that can effectively prevent
transplant rejections with an acceptable level of tolerability.
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. The animal studies found that
TNX-1500 retains activity to prevent rejection and preserve graft
function. We believe TNX-1500 has the potential for treating and
preventing organ transplant rejection in both allograft and
xenograft transplants. Tonix expects to initiate a Phase 1 trial of
TNX-1500 in the first half of 2023. Preventing transplant rejection
is the first indication we are pursuing, but based on results of
anti-CD40L in numerous animal models, we believe that TNX-1500 has
the potential for treating a number of autoimmune conditions.”
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 and
expects interim data in the first half of 2023. 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 first
quarter of 2023. TNX-1900 (intranasal potentiated oxytocin), a
small molecule in development for chronic migraine, is expected to
enter the clinic with a Phase 2 study in the fourth quarter of
2022. 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 infectious disease pipeline consists of a vaccine in
development to prevent smallpox and monkeypox, next-generation
vaccines to prevent COVID-19, and a platform to make fully human
monoclonal antibodies to treat COVID-19. 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 Kenya in the first half of 2023.
Tonix’s lead vaccine candidate for COVID-19 is TNX-1850, a live
virus vaccines based on Tonix’s recombinant pox live virus vector
vaccine platform. A Phase 1 study of the COVID-19 vaccine 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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