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 data presented at an oral Keynote Talk at the Vaccine
Congress 2024 held June 24-25, 2024 in Prague, Czech Republic. A
copy of the Company’s presentation is available under the
Scientific Presentations tab of the Tonix website at
www.tonixpharma.com.
The presentation titled, “A New Live Virus, One
Dose Vaccine Platform for Mpox, Smallpox and COVID-19”, detailed
the Company’s vaccine platform, including TNX-801 (horsepox, live
virus) vaccine for preventing mpox (formerly known as monkeypox)
and smallpox and TNX-1800 (horsepox expressing SARS-CoV-2 spike
protein) for protecting against COVID-19. TNX-801 and TNX-1800 are
live replicating attenuated vaccines based on horsepox that are
believed to provide immune protection with better tolerability than
modern vaccinia viruses. In the presentation, Tonix highlighted
positive preclinical efficacy data, demonstrating that TNX-801
protected non-human primates against lethal challenge with
intratracheal Clade 1 monkeypox virus3. After a single dose
vaccination, TNX-801 prevented clinical disease and lesions and
also decreased shedding in the mouth and lungs of non-human
primates. These findings are consistent with mucosal immunity and
suggest the ability to block forward transmission, similar to Dr.
Edward Jenner’s vaccinia vaccine, which eradicated smallpox and
kept mpox out of the human population.
“We are excited for the prospects of our live
virus vaccine platform and look forward to advancing development
for our vaccine candidates to prevent mpox, smallpox, COVID and
other infectious diseases,” said Seth Lederman, M.D., Chief
Executive Officer of Tonix. “TNX-801 combines immune protection
with improved tolerability compared to other vaccines based on
orthopoxviruses. TNX-801 is administered with a single dose which
has advantages over two-dose regimens. We believe TNX-801 can be
rapidly scaled up for manufacturing and can be distributed and
stored without a costly and cumbersome ultra-cold supply chain.
TNX-801 also has the potential to be used as a viral vector
platform, for which recombinant versions can be developed to
protect against other infectious diseases. Tonix developed TNX-1800
as a vaccine to protect against COVID-19. We are excited that
TNX-1800 was selected for the U.S. National Institute of Health’s
(NIH’s) Project NextGen and we look forward to providing updates on
the program.”
The presentation noted that the global mpox
outbreak, which commenced in 2022, has affected over 90,000 persons
in countries where mpox had previously not been endemic, including
Europe and the US. The spread of Clade IIb strain mpox in 2022
underscores the pandemic potential of mpox. Unlike Clade IIb mpox,
the Clade I strain of mpox remains restricted to several Central
African countries, including the Democratic Republic of the Congo,
where it is currently endemic. Clade I mpox is typically associated
with higher case fatality rates than Clade IIb mpox. According to
the U.S. Centers for Disease Control and Prevention (CDC), and
other experts, there is a significant risk that the deadlier Clade
I strain may appear in the U.S.1,4.
Further, the presentation noted that the
Bipartisan Commission on Biodefense recently highlighted the
renewed dual threats of both a more virulent mpox epidemic as well
as smallpox re-introduction from lab accidents or bad actors, while
the National Academies of Science, in its review of smallpox
preparedness, highlighted the need for new single dose vaccines
against smallpox5,6.
The keynote presentation also included
preclinical data for TNX-1800, demonstrating immunity and
tolerability7,8. TNX-1800 was selected by the NIH’s Project NextGen
for inclusion in clinical trials as part of a select group of next
generation COVID-19 vaccine candidates with the intent to identify
promising vaccine platforms. NIH plans to conduct a Phase 1 trial
and cover the full cost, while Tonix provides the vaccine
candidate.
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
Tonmya**, 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.
**Tonmya™ 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.
1McQuiston JH, et al. U.S. Preparedness and Response to
Increasing Clade I Mpox Cases in the Democratic Republic of the
Congo. 2024, MMWR Morb Mortal Wkly Rep: United States. p.
435-4402CDC. 2022-2023 Mpox: US Map and Case Count.
https://www.cdc.gov/poxvirus/mpox/response/2022/us-map.html3Noyce
RS, et al. Viruses. 2023 Jan 26;15(2):356. doi: 10.3390/v15020356.
PMID: 36851570; PMCID: PMC99652344World Health OrganizationSAGE
meeting highlights on updated mpox vaccine recommendations. 2024,
March5Bipartisan Commission on Biofence. Box the Pox: Redicing the
risk of Smallpox and Other Orthopoxviruses, Washington:20246U.S.
National Academies of Science. Future State of Smallpox Medical
Countermeasures. Washington:20247Awasthi M, et al. Viruses. 2023
Oct 21;15(10):2131. doi: 10.3390/v15102131. PMID: 37896908; PMCID:
PMC10612059.8Awashti AM et al Vaccines (Basel). 2023 Nov
2;11(11):1682. doi:10.3390/vaccines11111682.PMID: 38006014
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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