Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the
Company), a clinical-stage biopharmaceutical company, today
announced that the first patient was enrolled in the observational
COV-LOGIC study (TNX-C001), a study of humoral (antibody) and
cellular (T cell) immune responses to SARS-CoV-2 in volunteers who
have recovered or remain asymptomatic after exposure to
COVID-19. The research is part of an ongoing and broader
collaboration between Tonix and Southern Research to develop and
conduct animal testing of Tonix’s TNX-1800, which is a live
replicating, attenuated virus vaccine designed to protect against
COVID-19.
“This represents a significant milestone for the Company as the
data we plan to collect from recovered and asymptomatic COVID-19
volunteers in this study will help inform vaccine development on
how to safely provide the same immune responses that others got
from recovering from actual SARS-CoV-2 infection,” said Seth
Lederman, M.D., President and CEO of Tonix. “Our goal with
TNX-1800 is to develop a vaccine that is well tolerated, produces
strong, long-lasting immunity, and can be rapidly and broadly
deployed. The features of a protective immune response to
SARS-CoV-2 remain unknown. But since SARS-CoV-2 is a virus,
we believe that T cell responses, in particular T Helper Type 1, or
TH1 responses, will play an important, if not dominant, role in
protecting against serious illness from COVID-19.”
About the COV-LOGIC Study (TNX-C001)
The COV-LOGIC study is an observational multi-cohort sample
collection study designed to collect the blood and nasopharyngeal
(NP) swabs from individuals who have, and have not, been previously
infected with SARS-CoV-2, or who have been intimately exposed to
persons confirmed to have been infected with SARS-CoV-2, in order
to analyze their antibody titers and T-cell responses to specific
proteins of SARS-CoV-2 and to detect SARS-CoV-2 RNA which may be
persistent in the nasopharynx at the time of sampling. For those
individuals in whom viral RNA is detected during initial sampling,
repeat blood and NP swab samples may be collected to examine
temporal virus/immune response dynamics. In addition, blood
will be collected for DNA extraction and exome sequencing in order
to assess whether host genetic factors might influence these
humoral or cellular responses or viral persistence (if
identified).
About TNX-1800
TNX-1800 is a live modified horsepox virus vaccine for
percutaneous administration that is designed to express the Spike
protein of the SARS-CoV-2 virus that causes COVID-19 and to elicit
a predominant T cell response. 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
mice1. Horsepox-based vaccines are designed to be single
dose, vial-sparing vaccines, which can be manufactured on
conventional cell culturing systems, with the potential for mass
scale production.
1Noyce RS, et al. (2018) PLoS One. 13(1):e0188453
About Southern Research
Founded in 1941, Southern Research (SR) is an independent,
501(c)(3) nonprofit, scientific research organization with more
than 400 scientists and engineers working across three divisions:
Drug Discovery, Drug Development, and Engineering. SR has supported
the pharmaceutical, biotechnology, defense, aerospace,
environmental, and energy industries. SR works on behalf of the
National Institutes of Health, the U.S. Department of Defense, the
U.S. Department of Energy, NASA and other major aerospace firms,
utility companies, and other external academic, industry and
government agencies. SR pursues entrepreneurial and collaborative
initiatives to develop and maintain a pipeline of intellectual
property and innovative technologies that positively impact
real-world problems. SR has numerous ongoing drug discovery
programs, which encompass 18 drug candidates to combat various
forms of cancer, amyotrophic lateral sclerosis (ALS), Alzheimer’s,
schizophrenia, opioid use disorder, human immunodeficiency virus,
diabetes, kidney disease, Parkinson’s, tuberculosis, influenza, and
others. SR’s strong history, which includes over 75 years of
successful collaborations to solve complex problems, has led to the
discovery of seven FDA-approved cancer drugs—a number rivaling any
other U.S. research institute. Furthermore, experts at SR are
well-equipped to assist with the challenging landscapes of drug
design and development technologies and market viability. SR is
headquartered in Birmingham, Alabama with additional laboratories
and offices in Frederick, Maryland.
Further information about SR can be found at
https://southernresearch.org/
About Tonix Pharmaceuticals Holding Corp.Tonix
is a clinical-stage biopharmaceutical company focused on
discovering, licensing, acquiring and developing small molecules
and biologics to treat and prevent human disease and alleviate
suffering. Tonix’s portfolio is primarily composed of central
nervous system (CNS) and immunology product candidates. The
immunology portfolio includes vaccines to prevent infectious
diseases and biologics to address immunosuppression, cancer and
autoimmune diseases. The CNS portfolio includes both small
molecules and biologics to treat pain, neurologic, psychiatric and
addiction conditions. Tonix’s lead vaccine candidate, TNX-1800*, is
a live replicating vaccine based on the horsepox viral vector
platform to protect against COVID-19, primarily by eliciting a T
cell response. Tonix expects data from animal studies of TNX-1800
in the fourth quarter of this year. TNX-801*, live horsepox virus
vaccine for percutaneous administration, is in development to
protect against smallpox and monkeypox and serves as the vector
platform on which TNX-1800 is based. Tonix is also developing
TNX-2300* and TNX-2600*, live replicating vaccine candidates for
the prevention of COVID-19, but using bovine parainfluenza as the
vector. Tonix’s lead CNS candidate, TNX-102 SL**, is in Phase 3
development for the management of fibromyalgia. The Company expects
results from an unblinded interim analysis in September 2020 and
topline data in the fourth quarter of 2020. Tonix is also
currently enrolling patients in a second Phase 3 study for the
management of fibromyalgia using TNX-102 SL, the results for which
are expected in the second half of 2021. 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 AUD program
is also Phase 2 ready. 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 life-threatening cocaine
intoxication and has FDA Breakthrough Therapy designation. TNX-601
CR** (tianeptine oxalate controlled-release tablets) is another CNS
program, currently in Phase 1 development as a daytime treatment
for depression while TNX-1900**, intranasal oxytocin, is in
development as a non-addictive treatment for migraine and
cranio-facial pain. Tonix’s preclinical pipeline includes
TNX-1600** (triple reuptake inhibitor), a new molecular entity
being developed as a treatment for PTSD; 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-1800, TNX-801, TNX-2300, TNX-2600, TNX-1300, TNX-1500 and
TNX-1700 are investigational new biologics and have not been
approved for any indication.
**TNX-102 SL, TNX-601 CR, TNX-1600 and TNX-1900 are
investigational new drugs and have not been approved for any
indication.
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; 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.
Jessica Morris (corporate)Tonix
Pharmaceuticalsinvestor.relations@tonixpharma.com(212) 688-9421
Travis Kruse (media)Russo
Partnerstravis.kruse@russopartnersllc.com (212) 845-4272
Peter Vozzo (investors)Westwickepeter.vozzo@westwicke.com (443)
213-0505
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