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 the publication of a research paper in Microorganisms, a
scientific, peer-reviewed, open access journal of microbiology. The
article titled, “High-Throughput Screening Assay for Convalescent
Sera in COVID-19: Efficacy, Donor Selection, and Variant
Neutralization,” by Kota, et al.1, highlights proprietary
high-throughput, high-content imaging technology to screen
convalescent sera for generating neutralizing, fully-human
monoclonal antibodies (mAbs) against SARS-CoV-2 variants and
potentially other pathogens.
“This article highlights Tonix’s capabilities in
developing fully human mAbs against SARS-CoV-2 and other
pathogens,” said Seth Lederman, M.D., Chief Executive Officer of
Tonix Pharmaceuticals. “Our phenotypic imaging system can be used
to identify antibodies to counter SARS-CoV-2 and its variants and
potentially other infectious agents.”
“COVID-19 rates are on the rise again, and there
is growing concern that the short-term protection provided by mRNA
vaccines may not be sufficient to control COVID-19 as a public
health threat,” continued Dr. Lederman. “Our new publication
highlights the capabilities of Tonix’s screening and therapeutic
discovery and development technologies.”
In addition to this technology, Tonix has
several other research and development programs to prevent and
treat viral illnesses. Tonix is developing TNX-801, a live-virus
vaccine based on horsepox to protect against mpox and smallpox.
TNX-801 is also the vector underlying our Recombinant Pox Virus
(RPV) platform technology and to engineer vaccines to protect
against other viruses. TNX-1800, which uses the RPV technology, is
a potential vaccine against COVID-19 that was selected by National
Institute of Allergy and Infectious Diseases (NIAID), a part of the
National Institutes of Health (NIH), for inclusion in clinical
trials as part of its Project NextGen for prevention of COVID-19.
Tonix also is developing TNX-4200, an orally available CD45
antagonist with broad-spectrum efficacy against a range of viral
families. Tonix recently was awarded a $34 million contract from
the U.S. Department of Defense (DoD), Defense Threat Reduction
Agency (DTRA), to establish physicochemical properties,
pharmacokinetics, and safety attributes to support an
Investigational New Drug submission and to fund a first-in-human
Phase 1 clinical study using TNX-4200.
In support of our infectious disease programs,
Tonix’s experienced team utilizes 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 our research
and development center (RDC) located in Frederick, Md. The RDC is
located in Maryland’s “I-270 biotech corridor” and is close to the
center of the U.S. biodefense research community.
About TNX-4200*The TNX-4200
program aims 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. 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.
About Project
NextGenProject NextGen is a $5 billion initiative to
develop the next generation of vaccines and therapeutics to combat
COVID-19. Based at the HHS and led by the Administration for
Strategic Preparedness and Response’s Biomedical Advanced Research
and Development Authority and the NIH’s NIAID, Project NextGen was
stood up to coordinate across the federal government and the
private sector to advance the pipeline of new, innovative vaccines
and therapeutics into clinical trials and potential review by the
U.S. Food and Drug Administration (FDA) for authorization or
approval, and commercial availability for the American people. The
program will focus on several areas, including mucosal vaccines,
vaccines that provide broader protection against variants of
concern and a longer duration of protection, pan-coronavirus
vaccines, and new and more durable monoclonal antibodies.
About TNX-801* and Tonix’s RPV
PlatformTNX-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 modern vaccinia (VACV) strains
in immunocompromised mice.2 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.
About TNX-1800*TNX-1800
(recombinant horsepox virus) is a live virus vaccine for
percutaneous administration that is designed to express the spike
protein of the SARS-CoV-2 virus and to elicit a predominant T cell
response. Moreover, we believe the low dose of TNX-1800 makes this
technology amenable for future implementation in microneedle
delivery systems. NIAID will cover the full cost of Phase 1
clinical trials, while Tonix will supply the vaccine candidate. The
intent is to provide durable protection against severe disease and
prevent forward transmission, primarily by eliciting a T-cell
immune response. TNX-1800 expresses the spike protein of
SARS-CoV-2, was immunogenic, well tolerated3 and showed promise in
protecting animals from challenge with SARS-CoV-2 delivered
directly into the lungs.4
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 U.S. Food and Drug
Administration (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.
TNX-102 SL was awarded Fast Track designation from the FDA. Tonix
expects a decision on marketing approval from the FDA in 2025.
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 an
Fc-modified 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.
- Kota, K.P. et al. (2024) Microorganisms July 23,
2024.https://doi.org/10.3390/microorganisms1208150
- Trefry, SV et al., BioRxiv 2023.10.25.564033; doi:
https://doi.org/10.1101/2023.10.25.564033
- Awasthi M, et al. Viruses. 2023. 15(10):2131. doi:
10.3390/v15102131.
- Awasthi M et al Vaccines (Basel). 2023. 11(11):1682. doi:
10.3390/vaccines11111682.PMID: 38006014
Forward Looking
StatementsCertain 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 ContactJessica
MorrisTonix Pharmaceuticalsinvestor.relations@tonixpharma.com(862)
904-8182
Peter VozzoICR
Westwickepeter.vozzo@westwicke.com (443) 213-0505
Media ContactKatie
DodgeLaVoieHealthSciencekdodge@lavoiehealthscience.com(978)
360-3151
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