Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a
biopharmaceutical company with marketed products and a pipeline of
development candidates, today announced that the National Institute
of Allergy and Infectious Diseases (NIAID), a part of the National
Institutes of Health (NIH), will conduct a Phase 1 clinical trial
with TNX-1800 (recombinant horsepox virus, live vaccine),1 Tonix
Pharmaceuticals’ vaccine candidate to protect against COVID-19.
Tonix is developing a novel vaccine platform
initially targeting COVID-19, smallpox and mpox (monkeypox). 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 tolerated2 and showed promise in
protecting animals from challenge with SARS-CoV-2 delivered
directly into the lungs.3 A related horsepox-based vaccine,
TNX-8011, protected animals against challenge with monkeypox virus
delivered directly into the lungs.4 TNX-801 is also the vector on
which TNX-1800 is based and has been shown to be >1,000-fold
more attenuated than modern vaccinia virus vaccine (VACV) strains
in immunocompromised mice.5 The Phase 1 trial of TNX-1800 is
expected to start in the second half of 2024. NIAID will study
TNX-1800 by percutaneous administration.
“We believe our novel vaccine platform
technology has the potential to provide durable protection from
respiratory pathogens and slow their spread,” said Seth Lederman,
M.D., Chief Executive Officer of Tonix Pharmaceuticals. “TNX-1800
will be the first vaccine candidate using our live virus
recombinant pox virus (RPV) platform technology to enter clinical
trials. We hope to expand the portfolio of RPV-based vaccines to
address several other known respiratory threats including smallpox,
mpox and tuberculosis. We are committed to supporting NIAID in
assembling a variety of vaccine platform options to ensure the
availability of effective vaccines in the face of known and
emerging threats. We look forward to participating in the Project
NextGen initiative.”
“Project NextGen,” is an initiative by the U.S.
Department of Health and Human Services (HHS) to advance a pipeline
of new, innovative vaccines and therapeutics for COVID-19. NIAID
will be conducting clinical trials to evaluate several early-stage
vaccine candidates. The Phase 1 study involving TNX-1800 is
designed to assess safety and immunogenicity in approximately 60
healthy adult volunteers. Upon completion of the trial, NIAID and
Tonix Pharmaceuticals will assess the results and determine the
next steps for the development of TNX-1800.
NIAID will cover the full cost of the clinical
trial, including operations and related analysis. Tonix will be
responsible for providing clinical trial materials, and upon
completion will have the right to rely on the findings in
regulatory filings with the U.S. Food and Drug Administration (FDA)
to support the approval of its COVID-19 vaccine and other vaccines
based on the RPV platform.
About Project
NextGen
Project 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 will
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-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. The RPV platform is
based on a horsepox vector, which is a live replicating, attenuated
virus that has been shown to be >1,000-fold more attenuated than
modern VACV strains in immunocompromised mice.5 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. 6-9 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.4,6 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. Moreover, we believe the low dose of TNX-1800
makes this technology amenable for future implementation in
microneedle delivery systems.
About TNX-801*TNX-801
(recombinant horsepox virus) is a live virus vaccine based on
horsepox4-7 in pre-clinical development to prevent smallpox and
mpox. Tonix reported positive preclinical efficacy data,
demonstrating that TNX-801 vaccination protected non-human primates
against lethal challenge with monkeypox.4 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.10 Tonix believes the FDA
feedback provides a path to agreement on the design of a Phase 1 /2
study and the overall clinical development plan. The Phase 1/2
clinical trial will assess the safety, tolerability, and
immunogenicity of TNX-801, following the submission and clearance
of an IND. More than 30,000 people have contracted mpox in the U.S.
so far during the 2022-23 epidemic,11 The recent cluster of mpox in
Chicago revealed breakthrough cases of mpox in individuals who had
been vaccinated with the currently authorized non-replicating
vaccine, which is administered in two doses.12 In contrast, TNX-801
is delivered percutaneously with only one dose and therefore may
achieve higher rates of community protection by eliminating
drop-out between doses and limiting forward transmission. Moreover,
relying on only one approved mpox vaccine at present is a risk for
the global supply chain that has already led to insufficient
availability of vaccines to meet global health needs, especially in
Africa. 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.
Tonix Pharmaceuticals Holding
Corp.*
Tonix is a biopharmaceutical company focused on
commercializing, developing, discovering and licensing therapeutics
to treat and prevent human disease and alleviate suffering. Tonix
Medicines, our commercial subsidiary, markets Zembrace® SymTouch®
(sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray)
10 mg under a transition services agreement with Upsher-Smith
Laboratories, LLC from whom the products were acquired on June 30,
2023. Zembrace SymTouch and Tosymra are each indicated for the
treatment of acute migraine with or without aura in adults. Tonix’s
development portfolio is composed of central nervous system (CNS),
rare disease, immunology and infectious disease product candidates.
Tonix’s CNS development portfolio includes both small molecules and
biologics to treat pain, neurologic, psychiatric and addiction
conditions. Tonix’s lead development CNS candidate, TNX-102 SL
(cyclobenzaprine HCl sublingual tablet), is in mid-Phase 3
development for the management of fibromyalgia, having completed
enrollment of a potentially confirmatory Phase 3 study in the third
quarter of 2023, with topline data expected in late December 2023.
TNX-102 SL is also being developed to treat fibromyalgia-type Long
COVID, a chronic post-acute COVID-19 condition. Enrollment in a
Phase 2 proof-of-concept study has been completed, and topline
results were reported in the third quarter of 2023. TNX-1900
(intranasal potentiated oxytocin), is in development as a
preventive treatment for chronic migraine, and enrollment has been
completed in a Phase 2 proof-of-concept study with topline data
expected in early December 2023. TNX-1900 is also being studied in
binge eating disorder, pediatric obesity and social anxiety
disorder by academic collaborators under investigator-initiated
INDs. TNX-1300 (cocaine esterase) is a biologic designed to treat
cocaine intoxication and has been granted Breakthrough Therapy
designation by the FDA. A Phase 2 study of TNX-1300 is expected to
be initiated in the fourth quarter of 2023. Tonix’s rare disease
development portfolio includes TNX-2900 (intranasal potentiated
oxytocin) for the treatment of Prader-Willi syndrome. TNX-2900 has
been granted Orphan Drug designation by the FDA. Tonix’s immunology
development portfolio includes 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. A Phase 1
study of TNX-1500 was initiated in the third quarter of 2023.
Tonix’s infectious disease pipeline includes TNX-801, a vaccine in
development to prevent smallpox and mpox. TNX-801 also serves as
the live virus vaccine platform or recombinant pox vaccine platform
for other infectious diseases, including TNX-1800, in development
as a vaccine to protect against COVID-19. The infectious disease
development portfolio also includes TNX-3900 and TNX-4000, which
are classes of broad-spectrum small molecule oral antivirals.
*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. Intravail is a registered trademark
of Aegis Therapeutics, LLC, a wholly owned subsidiary of Neurelis,
Inc. All other marks are property of their respective owners.
1 TNX-1800 and TNX-801 are experimental new vaccines and have
not been approved for any indication.2 Awasthi, M. et al. Viruses.
2023. 15(10):2131.3 Awasthi, M. et al. BioRxiv. 2023.4 Trefry S, et
al. BioRxiv. 2023.5 Noyce RS, et al. Viruses. 2023. 15(2):356. 6
Jenner E. “An Inquiry Into the Causes and Effects of the
Variole Vaccinae, a Disease Discovered in Some of the Western
Counties of England, Particularly Gloucestershire and Known by the
Name of the cow‐pox.” London: Sampson Low, 1798.7 Noyce
RS, et al. PloS One. 2018. 13(1):e0188453.8 Schrick L et al. N Engl
J Med. 2017. 377:1491-1492.9 Tulman ER, et al. J Virol. 2006.
80(18):9244-58.10 TNX-801 PR pre-IND meeting August 20, 2023:
https://ir.tonixpharma.com/news-events/press-releases/detail/1417/tonix-pharmaceuticals-announces-results-of-pre-ind-meeting11
McQuiston JH, et al. MMWR Morb Mortal Wkly Rep. 2023. 72:547–552.12
Centers for Disease Control. MMWR Morb Mortal Wkly Rep. 2023.
72(25);696-698.
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, 2022, as filed
with the Securities and Exchange Commission (the “SEC”) on March
13, 2023, 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
Ben ShannonICR
Westwickeben.shannon@westwicke.com443-213-0495
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