Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the
Company), a fully-integrated biopharmaceutical company with
marketed products and a pipeline of development candidates, has
reiterated its commitment to advance development of its live
attenuated virus vaccine, TNX-801 (recombinant horsepox virus), for
preventing mpox (formerly known as monkeypox) and other infectious
diseases. On August 14, 2024, the World Health Organization (WHO)
determined that the upsurge of mpox in a growing number of
countries in Africa constitutes a public health emergency of
international concern, the second such declaration in the past two
years called in response to an mpox outbreak. The current outbreak
was caused by Clade 1 monkeypox virus, while the 2022 outbreak was
Clade 2 monkeypox virus.
TNX-801 is a live replicating attenuated vaccine
candidate based on horsepox that is believed to provide immune
protection with better tolerability than 20th century vaccinia
viruses. The same vaccine platform upon which TNX-801 is based was
selected by the U.S. National Institutes of Health (NIH) for
Project NextGen for an engineered version that expresses the spike
protein of SARS-CoV-2.
As previously disclosed, TNX-801 protected
animals against lethal challenge with intratracheal Clade 1
monkeypox virus4. After a single-dose vaccination, TNX-801
prevented clinical disease and lesions and also decreased shedding
in the mouth and lungs of non-human primates4. 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.
“The recent WHO declaration underscores the
urgent need for additional treatments to stop these outbreaks and
save lives,” said Seth Lederman, M.D., Chief Executive Officer of
Tonix. “We are motivated to advance development for our mpox
vaccine with urgency given the global public health emergency.
Preclinical trials demonstrate that TNX-801 combines immune
protection with improved tolerability and safety compared to other
vaccines based on orthopoxviruses, and is administered with a
single dose which has advantages over two-dose regimens. The
durability of protection from 19th century live virus vaccinia
vaccines suggests that our attenuated TNX-801 will not require
multiple repeated doses at six-month intervals like mRNA vaccines.
Also, the stability of live virus vaccines eliminates the need for
ultra-cold storage which complicates the widespread use of mRNA
vaccines in Africa, where they are needed most right now.”
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 U.S. 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 appears to be spreading to countries neighboring the
Democratic Republic of the Congo. Clade I mpox is typically
associated with approximately 20 times the case fatality rates than
Clade IIb mpox in Africa. 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.2,8
Further, the Bipartisan Commission on Biodefense
recently highlighted the renewed dual threats of a more virulent
mpox epidemic and a smallpox re-introduction from lab accidents or
bad actors9. The National Academies of Science, in its review of
smallpox preparedness, highlighted the need for new single dose
vaccines, like TNX-801 against smallpox10.
About TNX-801* and Tonix’s RPV
Platform
TNX-801 (recombinant horsepox virus) is a live
virus vaccine for percutaneous administration that is being
developed to target smallpox, and mpox (monkeypox). TNX-801 is also
the basis of the RPV platform based on a horsepox vector, which is
being adapted as a COVID-19 vaccine, term TNX-1800*. Horsepox is a
live replicating, attenuated virus that has been shown to be
>1,000-fold more attenuated than 20th century vaccinia (VACV)
strains in immunocompromised mice. Horsepox and the vaccinia
vaccine viruses are closely related orthopoxviruses that are
believed to share a common ancestor. Molecular analysis shows that
horsepox is closer than modern vaccinia vaccines in DNA sequence to
the vaccine discovered and disseminated by Dr. Edward Jenner. Live
replicating orthopoxviruses, like vaccinia or horsepox, can be
engineered to express foreign genes and have been explored as
platforms for vaccine development because they possess; (1) large
packaging capacity for exogenous DNA inserts, (2) precise
virus-specific control of exogenous gene insert expression, (3)
lack of persistence or genomic integration in the host, (4) strong
immunogenicity as a vaccine, (5) ability to rapidly generate
vector/insert constructs, (6) readily manufacturable at scale, and
(7) ability to provide direct antigen presentation. Relative to
vaccinia, horsepox has substantially decreased virulence in mice.
The current formulation is a frozen liquid, but we believe that
future lyophilized versions can be stored and shipped at standard
refrigeration. Horsepox-based vaccines are designed to be single
dose, vial-sparing vaccines that can be administered without
sterile injection, manufactured using conventional cell culture
systems with the potential for mass scale production, and packaged
in multi-dose vials.
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 recently announced the U.S. Department of Defense
(DoD), Defense Threat Reduction Agency (DTRA) awarded it a contract
for up to $34 million over five years in an Other Transaction
Agreement (OTA) to develop TNX-4200 small molecule broad-spectrum
antiviral agents targeting CD45 for the prevention or treatment of
infections to improve the medical readiness of military personnel
in biological threat environments. Tonix owns and operates a
state-of-the art infectious disease research facility in Frederick,
MD. The company’s Good Manufacturing Practice (GMP)-capable
advanced manufacturing facility in Dartmouth, MA was purpose-built
to manufacture TNX-801 and the GMP suites are ready to be
reactivated in case of a national or international emergency.
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 TNX-102
SL, a product candidate for which two statistically significant
Phase 3 studies have been completed for the management of
fibromyalgia. The FDA has granted Fast Track designation to TNX-102
SL for the management of fibromyalgia. TNX-102 SL is also being
developed to treat acute stress reaction. 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.
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.
1WHO Press Release August 14, 2024. “WHO
Director-General declares mpox outbreak a public health emergency
of international concern”. URL:
www.who.int/news/item/14-08-2024-who-director-general-declares-mpox-outbreak-a-public-health-emergency-of-international-concern
(accessed 8-15-24)2McQuiston 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. 435-4403CDC. 2022-2023 Mpox: US Map and Case Count.
https://www.cdc.gov/poxvirus/mpox/response/2022/us-map.html 4Noyce
RS, et al. Viruses. 2023 Jan 26;15(2):356. doi:
10.3390/v150203565Trefry, SV et al.
bioRxiv 2023.10.25.564033;
https://doi.org/10.1101/2023.10.25.564033 6Awasthi M, et al.
Viruses. 2023 Oct 21;15(10):2131. doi: 10.3390/v15102131. 7Awashti
M et al Vaccines (Basel). 2023 Nov 2;11(11):1682.
doi:10.3390/vaccines11111682.8World Health Organization SAGE
meeting highlights on updated mpox vaccine recommendations. 2024,
March9Bipartisan Commission on Biofense. Box the Pox: Reducing the
risk of Smallpox and Other Orthopoxviruses, Washington: 202410U.S.
National Academies of Science. Future State of Smallpox Medical
Countermeasures. Washington: 2024
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
Lisa
DeScenzaLaVoieHealthScienceldescenza@lavoiehealthscience.com(617)
351-0243
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