Tonix Pharmaceuticals Awarded Up to $34 Million U.S. Department of Defense Contract for Accelerated Development of Broad-Spectrum Antiviral Program
01 Julho 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, today
announced it has been awarded an Other Transaction Agreement (OTA)
with a potential for up to $34 million over five years by the
Defense Threat Reduction Agency (DTRA), an agency within the U.S.
Department of Defense (DoD). The objective of the contract is to
develop small molecule broad-spectrum antiviral agents for the
prevention or treatment of infections to improve the medical
readiness of military personnel in biological threat environments.
Tonix’s program will focus on optimization and
development of its TNX-4200 program, to develop an orally available
CD45 antagonist, with broad-spectrum efficacy against a range of
viral families through preclinical evaluation. The program is
expected to establish physicochemical properties, pharmacokinetics,
and safety attributes to support an Investigational New Drug (IND)
submission and to fund a first-in-human Phase 1 clinical study.
“Through our agreement with DTRA, our
broad-spectrum antiviral research program will address the DoD’s
goal of protecting U.S. Joint Forces in the event biological
weapons are introduced onto the battlefield,” said Seth Lederman,
M.D., President, and Chief Executive Officer of Tonix. “The DoD
announced in December 2022 that they are moving beyond a ‘one bug,
one drug’ approach and are seeking broad-spectrum drugs since one
cannot predict which or how many viruses may be deployed.1 This
funding provides important validation for our ongoing research and
current in-house capabilities, and will enable Tonix to advance its
antiviral discovery program.”
The $34 million five-year contract will help
fund and accelerate the development of the Company’s broad-spectrum
antiviral program, which has the potential to reduce viral load and
allow the adaptive immune system to alert the other arms of the
immune system to mount a protective response. Tonix plans to
leverage previous research on phosphatase inhibitors, specifically
compounds that target CD45, to optimize lead compounds for
therapeutic intervention of biothreat agents and provide the
government with a complete and cost-effective solution for a
broad-spectrum medical countermeasure. Tonix’s premise is that
partial inhibition of CD45 will provide optimal antiviral
protection while requiring lower plasma drug concentrations, a
lower dose, and a better safety profile.
Tonix will utilize its state-of-the-art research
laboratory capabilities, including a Biosafety Level 3 (BSL-3) lab
and an Animal Biosafety Level 3 (ABSL-3) facility at its research
and development center (RDC) located in Frederick, Md., as well as
experienced personnel in-house. The RDC is located in Maryland’s
‘I-270 biotech corridor’ and is close to the center of the U.S.
biodefense research community.
1 “Approach for Research, Development, and
Acquisition of Medical Countermeasure and Test Products.” 2022.
Chemical and Biological Defense Program. U.S. Department of
Defense.
https://media.defense.gov/2023/Jan/10/2003142624/-1/-1/0/APPROACH-RDA-MCM-TEST-PRODUCTS.PDF
(accessed March 5, 2024)
About Defense Threat Reduction Agency
(DTRA)
The Defense Threat Reduction Agency (DTRA), an
agency within the United States Department of Defense (DoD) is both
a Defense Agency and Combat Support Agency with two distinct yet
highly integrated roles countering Weapons of Mass Destruction
(WMD) and emerging threats. Its origins stretch back to World War
II and the Manhattan Project, but today the agency encompasses a
wide variety of strategic and operational functions that deter,
prevent, and ultimately prevail against these unique threats. DTRA
enables the Department of Defense (DoD), the United States
Government and international partners to counter and deter weapons
of mass destruction (WMD) and emerging threats. DTRA provides
cross-cutting solutions to enable the Department of Defense, the
United States Government, and international partners to deter
strategic attack against the United States and its allies; prevent,
reduce, and counter WMD and emerging threats; and prevail against
WMD-armed adversaries in crisis and conflict. DTRA’s continued
effort to enhance the combat support mission also advances public
health services by developing innovative technologies that protect
against biological threats. For more information, visit
www.dtra.mil.
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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