Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the
Company), a clinical-stage biopharmaceutical company, and the
University of Alberta, a leading Canadian research university,
announced today a new research collaboration and exclusive
licensing agreement for three new vaccines for the prevention of
COVID-19, the novel coronavirus disease identified in 2019 which is
caused by SARS-CoV-2 virus. The new collaboration will
develop three new potential vaccines to protect against COVID-19
based on the horsepox vector platform, but designed to express
different SARS-CoV-2 antigens than TNX-1800, which is designed to
express SARS-CoV-2 Spike protein.
“We are excited to expand our pipeline and look
forward to developing three additional potential vaccines,
TNX-1810, TNX-1820 and TNX-1830 to protect against COVID-19,” said
Seth Lederman, M.D., Tonix's President and Chief Executive
Officer. “We are delighted to extend our relationship with
David Evans, Ph.D., FCAHS, Professor and former Vice-Dean
(Research) Faculty of Medicine and Dentistry at the University of
Alberta and principal investigator of the TNX-1810, TNX-1820 and
TNX-1830 research project, and Ryan Noyce, Ph.D., Research
Associate in Professor Evans’ laboratory at the University of
Alberta. Drs. Evans and Noyce synthesized horsepox, which is
now our TNX-801 potential vaccine for smallpox and monkeypox.
Horsepox is the vector system that is the backbone of the TNX-1800
vaccine that is designed to express the SARS-CoV-2 Spike protein,
which Tonix is developing for the prevention of COVID-19 in
collaboration with the Southern Research Institute. Horsepox
is also the vector system for the new TNX-1810, TNX-1820 and
TNX-1830 vaccines. TNX-801 is designed to elicit
predominantly T cell responses, while the new vaccines are designed
to elicit almost purely T cell responses.”
“We are excited to extend our productive
collaboration with Tonix. Tonix brings expertise in
immunology, particularly with Dr. Lederman’s direct involvement in
these programs, which complements our expertise in virology.
TNX-1810, TNX-1820 and TNX-1830 are designed to express different
protein antigens from SARS-CoV-2,” said Dr. Evans. “It is
currently unknown what type of vaccine and which antigens from
SARS-CoV-2 will provide effective protection from COVID-19.
Orthopoxviruses like horsepox induce strong innate and adaptive
immunity and long-lasting T-cell immunity. We have designed
TNX-1810, TNX-1820 and TNX-1830 to express and induce immunity to
SARS-CoV-2 proteins that are different from Spike. We are
delighted to be extending our collaboration with Tonix to bring
these candidate vaccines through further development and
testing.”
Under the terms of the research collaboration
agreement, Tonix has been granted an exclusive license from the
University of Alberta for technology and patents related to
TNX-1810, TNX-1820 and TNX-1830. Tonix will conduct further
studies to test the safety and efficacy of TNX-1810, TNX-1820 and
TNX-1830 in preventing COVID-19. TNX-1810, TNX-1820 and TNX-1830
are in the Pre-Investigational New Drug (IND) application stage of
development.
About TNX-1800*
TNX-1800 (live modified horsepox virus vaccine for
percutaneous administration) is a modified horsepox virus that is
designed to express the Spike protein of the SARS-CoV-2 virus that
causes COVID-19. TNX-801 is a live virus vaccine based on
synthesized horsepox. Horsepox and vaccinia are closely
related orthopoxviruses that are believed to share a common
ancestor. 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. TNX-801 vaccinated
macaques showed no overt clinical signs after monkeypox
challenge.
About Tonix Pharmaceuticals Holding
Corp.
Tonix is a clinical-stage biopharmaceutical company
focused on discovering, licensing, acquiring and developing drugs
and biologics to treat and prevent human disease and alleviate
suffering. Tonix’s current portfolio includes biologics to prevent
infectious diseases, and small molecules and biologics to treat
pain, psychiatric and addiction conditions. Tonix is developing
four potential vaccines, based on the horsepox viral vector
platform to protect against the novel coronavirus disease emerging
in 2019, or COVID-19: TNX-1800, TNX-1810, TNX-1820 and
TNX-1830*. TNX-1800 is designed to express the Spike protein
of the SARS-CoV-2 virus that causes COVID-19. TNX-1810,
TNX-1820 and TNX-1830 are designed to express different proteins
from SARS-CoV-2. TNX-801* (live horsepox virus vaccine for
percutaneous administration) is in development to protect against
smallpox and monkeypox. Tonix’s most advanced drug development
programs are focused on delivering safe and effective long-term
treatments for fibromyalgia, or FM, and posttraumatic stress
disorder, or PTSD. Tonix’s most advanced product candidate, TNX-102
SL**, is in Phase 3 development as a bedtime treatment for
fibromyalgia and PTSD. The Company is enrolling participants in the
Phase 3 RELIEF trial in fibromyalgia and expects results from an
unblinded interim analysis in September of 2020 and topline data in
the first quarter of 2021. The Phase 3 RECOVERY trial (P302)
for TNX-102 SL (trade name Tonmya***) in PTSD has stopped
enrollment based on the Independent Data Monitoring Committee’s
recommendation to stop the study for futility following an interim
analysis of the first 50% of enrolled participants. Topline data
for RECOVERY are expected in the second quarter of 2020. TNX-102 SL
for PTSD has U.S. Food and Drug Administration (FDA) Breakthrough
Therapy Designation. TNX-102 SL is also in development for
agitation in Alzheimer’s disease and alcohol use disorder (AUD).
The agitation in Alzheimer’s disease program is Phase 2 ready with
FDA Fast Track designation, and the development program for AUD is
in the pre-Investigational New Drug (IND) application stage.
Tonix‘s programs for treating addiction conditions also include
TNX-1300* (T172R/G173Q double-mutant cocaine esterase 200 mg, i.v.
solution), which is in Phase 2 development for the treatment of
cocaine intoxication and has FDA Breakthrough Therapy Designation.
TNX-601 CR (tianeptine oxalate controlled-release tablets) is in
development as a daytime treatment for depression as well as PTSD
and corticosteroid-induced cognitive dysfunction. The first
efficacy study will be in the treatment of major depressive
disorder. TNX-1600 (a triple reuptake inhibitor) is a pre-clinical
new molecular entity (NCE) being developed as a treatment for PTSD.
Tonix’s preclinical pipeline includes TNX-1500 (anti-CD154), a
monoclonal antibody being developed to prevent and treat organ
transplant rejection and autoimmune conditions, and TNX-1700
(rTFF2), a biologic being developed to treat gastric and pancreatic
cancers. TNX-1200* (live vaccinia virus vaccine for percutaneous
administration) is in development to protect against smallpox and
monkeypox. Finally, TNX-701 (undisclosed small molecule) to prevent
radiation effects is being advanced as a medical countermeasure to
improve biodefense.
*TNX-1800, TNX-1810, TNX-1820, TNX-1830, TNX-801,
TNX-1200 and TNX-1300 are investigational new biologics and have
not been approved for any indication.
**TNX-102 SL (cyclobenzaprine HCl sublingual
tablets) is an investigational new drug and has not been approved
for any indication.
***Tonmya has been conditionally accepted by the
FDA as the proposed trade name for TNX-102 SL for the treatment of
PTSD.
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 failure to obtain FDA clearances or approvals and
noncompliance with FDA regulations; delays and uncertainties caused
by the global COVID-19 pandemic; 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, 2019, as filed with the Securities and
Exchange Commission (the “SEC”) on March 24, 2020, 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.
Contacts
Bradley Saenger (corporate) Tonix
Pharmaceuticals investor.relations@tonixpharma.com(212)
980-9155
Travis Kruse (media) Russo
Partners travis.kruse@russopartnersllc.com(212) 845-4272
Peter Vozzo (investors) Westwicke
peter.vozzo@westwicke.com(443) 213-0505
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