Tonix Pharmaceuticals Announces Two Oral Presentations and One Poster Presentation Involving TNX-1500 (Fc-modified humanized anti-CD40L mAb) at the American Transplant Congress 2024
06 Junho 2024 - 9:00AM
Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the
Company), a fully-integrated biopharmaceutical company with
marketed products and a pipeline of development candidates,
announces two oral presentations and a poster presentation at the
American Transplant Congress 2024, held June 1-5, 2024 at the
Pennsylvania Convention Center, Philadelphia, Pa. A copy of the
oral and poster presentation is available under the Scientific
Presentations tab of the Tonix website at www.tonixpharma.com.
“We remain encouraged by the potential of our
TNX-1500, Fc-modified humanized anti-CD40L monoclonal antibody
therapy for the prevention of rejection in solid organ
transplantation,” said Seth Lederman, M.D., Chief Executive Officer
of Tonix Pharmaceuticals. “Despite advancements in the field of
solid organ transplantation, there remains a significant need for
new treatments with improved activity and tolerability. Several
lines of research indicate that anti-CD40L therapy may improve
outcomes for allograft acceptance, and that anti-CD40L therapy may
be required for long term xenograft acceptance. We are excited
about the broad potential of TNX-1500, on the prevention of
allograft and xenograft rejection and also for the treatment of
autoimmune diseases like systemic lupus erythematosus and Sjögren’s
Syndrome.”
In the oral presentation titled, “Combined Blockade of the CD154
and CD28 Co-Stimulation Pathways Attenuates Pathogenic Alloimmunity
and Prolongs Survival in Cynomolgus Cardiac Allografts”, by
Kinoshita, K. et al., data demonstrated that the combined use of
TNX-1500 and anti-CD28 monoclonal antibody, VEL-101 is associated
with durable protection and graft survival and function in a
nonhuman primate model.
In the oral presentation titled, “Extended
Survival of 9- and 10-Gene-Edited Pig Heart Xenografts with
Ischemia Minimization and CD154 Costimulation Blockade-Based
Immunosuppression”, Sanatkar, A. et al., data demonstrated that
TNX-1500 has promise to prevent rejection of 9-, or 10-gene-edited
(GE) pig hearts.1,2
The poster presentation titled, “Experience with
a Novel Delayed Immune Tolerance Protocol in Nonhuman Primates
Based on Anti-CD154, Anti-CD2, and Anti-CD28”, by Ileka, I.
evaluated whether a modified protocol based on targeting CD28 and
CD2 promotes expansion of peripheral regulatory T-cells and is
sufficient to promote heart allograft acceptance.
In February 2024, Tonix announced completion of
the clinical stage of its Phase 1 single ascending dose study of
TNX-1500 in healthy volunteers. The primary objectives of the study
are to assess the safety, tolerability, pharmacokinetics and
pharmacodynamics of intravenous TNX-1500. This first-in-human study
is intended to support dosing in a planned Phase 2 trial in kidney
transplant recipients.
About TNX-1500
TNX-1500 (Fc-modified humanized anti-CD40L mAb)
is a humanized monoclonal antibody that binds and blocks the
CD40-ligand (CD40L), also known as CD154. TNX-1500 is being
developed for the prevention of allograft and xenograft rejection,
for the prevention of graft-versus-host disease (GvHD) after
hematopoietic stem cell transplantation (HCT) and for the treatment
of autoimmune diseases. A first-in-human Phase 1 trial of TNX-1500
has completed the clinical phase. The primary objective of the
Phase 1 trial is to assess the safety, tolerability, PK, and
pharmacodynamics of intravenous (i.v.) TNX-1500. Eligible
participants enrolled in the Phase 1 trial were distributed across
three dosing cohorts (3 mg/kg, 10 mg/kg, and 30 mg/kg,
respectively) and evaluated regularly over a 120-day period after
dosing. The Phase 1 trial is intended to support dosing in a
planned Phase 2 trial in kidney transplant recipients. Two
published articles in the American Journal of Transplantation
demonstrate TNX-1500 prevents rejection, prolongs survival and
preserves graft function as a single agent or in combination with
other drugs in non-human primate renal and heart allografts.
3,4
- Revivicor 9-GE pigs:
GalKO.β4GalNT2KO.GHRKO.hCD46.hCD55.hTBM.hEPCR.hCD47.hHO-1
- Revivicor 10-GE pigs:
GalKO.β4GalNT2KO.CMAHKO.GHRKO.hCD46.CD55.hTBM.hEPCR.hCD47.hHO-1.
- Lassiter G., et al. Am J
Transplantation.
2023. https://doi.org/10.1016/j.ajt.2023.03.022
- Miura S., et al. Am J
Transplantation.
2023. https://doi.org/10.1016/j.ajt.2023.03.025
Tonix Pharmaceuticals Holding
Corp.*
Tonix is a fully-integrated biopharmaceutical
company focused on developing, licensing and commercializing
therapeutics to treat and prevent human disease and alleviate
suffering. Tonix’s development portfolio is focused on central
nervous system (CNS) disorders. Tonix’s priority is to submit a New
Drug Application (NDA) to the FDA in the second half of 2024 for
Tonmya1, a product candidate for which two statistically
significant Phase 3 studies have been completed for the management
of fibromyalgia. TNX-102 SL is also being developed to treat acute
stress reaction as well as fibromyalgia-type Long COVID. Tonix’s
CNS portfolio includes TNX-1300 (cocaine esterase), a biologic
designed to treat cocaine intoxication that has Breakthrough
Therapy designation. Tonix’s immunology development portfolio
consists of 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. Tonix also has product candidates
in development in the areas of rare disease and infectious disease.
Tonix Medicines, our commercial subsidiary, markets Zembrace®
SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan
nasal spray) 10 mg for the treatment of acute migraine with or
without aura in adults.
*Tonix’s product development candidates are
investigational new drugs or biologics and have not been approved
for any indication.
1Tonmya™ is conditionally accepted by the U.S.
Food and Drug Administration (FDA) as the tradename for TNX-102 SL
for the management of fibromyalgia. Tonmya has not been approved
for any indication.
Zembrace SymTouch and Tosymra are registered
trademarks of Tonix Medicines. 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, 2023, as filed
with the Securities and Exchange Commission (the “SEC”) on April 1,
2024, 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
Katie DodgeLaVoieHealthSciencekdodge@lavoiehealthscience.com
(978) 360-3151
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