Tonix Pharmaceuticals Announces New Data Involving TNX-1500 (Fc-modified dimeric anti-CD40L mAb) in Heart Xenotransplantation in Animal Models at the ACS Clinical Congress and IPITA-IXA-CTRMS Joint Congress
30 Outubro 2023 - 8:00AM
Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the
Company), a biopharmaceutical company with marketed products and a
pipeline of development candidates, today announced data from two
oral presentations which were delivered recently at the American
College of Surgeons (ACS) Clinical Congress 2023, and The
International Pancreas and Islet Transplant Association (IPITA),
the International Xenotransplantation Association (IXA), and the
Cell Transplant and Regenerative Medicine Society (CTRMS) Joint
Congress by faculty at the Center for Transplantation Sciences,
Massachusetts General Hospital (MGH) in October 2023. The data
involve Tonix’s TNX-1500 (Fc-modified dimeric anti-CD40L monoclonal
antibody [mAb]) which is currently in Phase 1 development for the
prevention of organ transplant rejection. Copies of the
presentations are available under the Scientific Presentations
tab of the Tonix Pharmaceuticals website at www.tonixpharma.com.
The oral presentations titled, “Pilot Evaluation
of a Clinical Xeno Heart Transplant Regimen in a Preclinical Model”
and “Extended Survival of 9- and 10-Gene Edited Pig Heart
Xenografts with Ischemia Minimization and CD154 Costimulation
Blockade-Based Immunosuppression” by Dr. Ikechukwu Ileka et al.
include data demonstrating the use of TNX-1500 as maintenance
therapy after xeno heart transplant in non-human primates. In both
studies, genetically engineered (GE) pigs in baboon transplants
were treated with cold-perfused ischemia minimization and a novel
costimulation-based immunosuppressive regimen including TNX-1500.
The multi-GE pigs were provided by eGenesis and Revivicor.
“The results of these preclinical studies are
encouraging and demonstrate the potential of genetically engineered
pig hearts in the context of a clinically applicable regimen,” said
Seth Lederman, M.D., Chief Executive Officer of Tonix
Pharmaceuticals. “Because anti-CD40L treatment is widely recognized
as critical to the success of xeno organ transplant, no animals
were transplanted without anti-CD40L treatment.”
“These and other data1,2,3 confirm the rationale
for us to pursue development of TNX-1500 to prevent rejection in
human transplantation,” said Dr. Lederman. “We are currently
enrolling in a Phase 1 trial in healthy volunteers to support the
development of TNX-1500 for the prevention of allograft rejection.
However, long term we hope to develop TNX-1500 for
xenotransplantation in which the donor organ comes from genetically
engineered pigs.”
1Lassiter G., et al. Am. J. Transplant. 2023.
https://doi.org/10.1016/j.ajt.2023.03.022
2Miura S., et al. Am. J. Transplant. 2023.
https://doi.org/10.1016/j.ajt.2023.03.025
3Anand R.P., et al. Nature. 2023. 622,
393–401.
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 late December 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 study in the
third quarter of 2023, with topline results expected in early
November of 2023. TNX-4300 (estianeptine) is a single isomer
version of TNX-601, a 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 mu-opioid receptor while maintaining activity and
the ability to activate PPAR-β/δ and neuroplasticity in tissue
culture. TNX-1900 (intranasal potentiated oxytocin), is in
development as a preventive treatment in chronic migraine, and the
clinical phase of a Phase 2 proof-of-concept study is now completed
with topline data expected in early December 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 fourth quarter
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, including TNX-1800, in development as a vaccine to
protect against COVID-19. 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; 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.
Investor ContactJessica MorrisTonix
Pharmaceuticalsinvestor.relations@tonixpharma.com(862) 904-8182
Peter VozzoICR Westwickepeter.vozzo@westwicke.com(443)
213-0505
Media ContactBen ShannonICR
Westwickeben.shannon@westwicke.com443-213-0495
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