Full Press Release Details
Tonix Pharmaceuticals Holding Corp. 8-K
Tonix Pharmaceuticals Presented Data on Potential
Mpox Vaccine TNX-801 at World Vaccine Congress Washington 2025
TNX-801 is a single-dose, live virus vaccine in
development to protect against mpox and smallpox
TNX-801 protects immunocompromised animals from
a lethal challenge with clade IIa monkeypox virus
Durability of TNX-801 vaccination shown by six-month
protection of animals from a lethal challenge with rabbitpox
Tolerability of TNX-801 demonstrated in immunocompromised
animals by no spreading to blood or tissues, even at high doses
CHATHAM, N.J., April 24, 2025 - Tonix
Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed products
and a pipeline of development candidates, presented data in an oral presentation at the World Vaccine Congress Washington 2025, held April
21-24, 2025, in Washington, D.C. The presentation titled, "A Novel Single-Dose, Attenuated Live, Minimally Replicative Mpox Vaccine",
highlighted positive preclinical efficacy data, demonstrating that TNX-801 protected animals from mpox and rabbitpox and was well tolerated,
even in immunocompromised animals. A copy of the Company's presentation is available under the Scientific
Presentations tab of the Tonix website at www.tonixpharma.com.
"TNX-801 shows promise as a potential mpox and
smallpox vaccine by providing protective immunity to animals with a single-dose," said Seth Lederman, M.D., Chief Executive Officer
of Tonix Pharmaceuticals. "TNX-801 was generally well tolerated, even in immunocompromised animals. The new data show durable six-month
protection against a lethal challenge with rabbitpox virus and protection of immunocompromised animals against a lethal challenge with
monkeypox clade IIa virus. These new data build upon prior studies showing protection of animals against a lethal challenge with intratracheal
clade Ia mpox virus. In all of these studies, after a single dose vaccination, TNX-801 prevented both clinical disease and formation of
Dr. Lederman continued, "The ongoing clade IIb
mpox epidemic that started in 2022, and the more recent and ongoing clade Ib mpox epidemic, highlight the need for additional vaccine
options, particularly single-dose options. Both the 2022 clade IIb and the 2024 clade Ib mpox epidemics have been declared by the World
Health Organization (WHO) to be Public Health Emergencies of International Concern (PHEICs). We believe TNX-801 has the potential to make
an impact towards preventing mpox and controlling future mpox epidemics."
TNX-801 is a minimally replicative, live-virus
vaccine based on synthesized horsepox that has been shown to provide single-dose immune protection against a monkeypox challenge with
better tolerability than 20th century vaccinia live-virus vaccines in animals. In September 2024, Tonix announced that the
WHO's preferred target product profile (TPP), released at the WHO sponsored Mpox Research and Innovation Scientific Conference,
aligns with the characteristics of TNX-801. Key elements of the WHO draft TPP include single-dose, durable protection, administration
without special equipment, and stability at ambient temperature. Other potential beneficial characteristics include the ability to limit
forward transmission, use in case-contact vaccination strategies and suitability for use in immunocompromised individuals.
TNX-801 (recombinant horsepox virus) is a single-dose,
attenuated, minimally replicative, live virus vaccine based on horsepox in pre-clinical development to prevent mpox and smallpox. Tonix
reported positive preclinical efficacy data, demonstrating that TNX-801 vaccination protected non-human primates against lethal challenge
with monkeypox. After a single dose vaccination, TNX-801 prevented clinical disease and lesions and decreased shedding in the mouth and
lungs of non-human primates. The findings are consistent with mucosal immunity and suggest the ability to block forward transmission,
similar to Dr. Edward Jenner's vaccine, which eradicated smallpox and kept mpox out of the human population. TNX-801 is based on
synthesized horsepox which is believed to be more closely related to Dr. Jenner's vaccine than 20th century vaccinia
viruses.6 Smallpox vaccines descended from Jenner's vaccine used prior to 1900 would be called horsepox by modern nomenclature.
TNX-801 is delivered percutaneously with only one dose and therefore may achieve higher rates of community protection than two-dose vaccines
by eliminating drop-out between doses and limiting forward transmission. Tonix has received official written response from a Type B pre-Investigational
New Drug Application (IND) meeting with the U.S. Food and Drug Administration (FDA) to develop TNX-801 as a potential vaccine to protect
against mpox disease and smallpox. Tonix has announced a collaboration with the Kenya Medical Research Institute (KEMRI) to design, plan
and seek regulatory approval for a Phase I clinical study of TNX-801 in Kenya. The Company believes TNX-801 has the potential to make
a global impact on mpox and the risk of smallpox because of its durable T-cell immune response, the potential to manufacture at scale,
and the use of a lower dose than non-replicating vaccines. The FDA-approved non-replicating mpox vaccine Jynneos requires two doses
and provides a relatively short duration of protection. FDA also recently approved ACAM2000, a live, replicating vaccinia vaccine for
prevention of mpox. ACAM200 is a clone from DryVax , a 20th century vaccinia vaccine derived from the NYCBH strain. Pre-clinical
results from an mRNA vaccine recently showed some protection from a Clade I monkeypox challenge, but with multiple break-through lesions
in vaccinated animals.
About Tonix Pharmaceuticals Holding Corp.*
Tonix is a fully integrated biopharmaceutical company
focused on transforming therapies for pain management and vaccines for public health challenges. Tonix's development portfolio
is focused on central nervous system (CNS) disorders. Tonix's priority is to advance TNX-102 SL, a product candidate for the management
of fibromyalgia, for which an NDA was submitted based on two statistically significant Phase 3 studies for the management of fibromyalgia
and for which a PDUFA (Prescription Drug User Fee act) goal date of August 15, 2025 has been assigned for a decision on marketing authorization.
The FDA has also 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 and acute stress disorder under a Physician-Initiated IND at the University of North Carolina in the OASIS
study funded by the U.S. Department of Defense (DoD). Tonix's CNS portfolio includes TNX-1300 (cocaine esterase), a biologic in
Phase 2 development designed to treat cocaine intoxication that has FDA Breakthrough Therapy designation, and its development is supported
by a grant from the National Institute on Drug Abuse. 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's infectious disease portfolio includes TNX-801, a vaccine in development for mpox and smallpox, as well as TNX-4200 for
which Tonix has a contract with the U.S. Department of Defense's (DoD's) Defense Threat Reduction Agency (DTRA) for up to $34 million over five years. TNX-4200
is a small molecule broad-spectrum antiviral agent 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. 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. Their efficacy and safety have not been established 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.
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, 2024, as filed with the Securities and Exchange Commission (the "SEC") on March 18, 2025, 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.
Tonix Pharmaceuticals