Tonix Pharmaceuticals Announces Research Collaboration to Develop Precision Medicine Techniques for COVID-19 Vaccines and The...
July 16 2020 - 9:00AM
Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the
Company), a clinical-stage biopharmaceutical company, today
announced it has entered into a research collaboration and option
agreement with Columbia University focused on studying the immune
responses to COVID-19 in healthy volunteers who have recovered from
COVID-19 or were asymptomatic. The research collaboration will
focus on T cell and antibody responses to SARS-CoV-2 (CoV-2), the
virus that causes COVID-19 at the cellular level including human
monoclonal antibodies and anti-idiotypes. The research is designed
to fill in important gaps in understanding the detailed immune
responses to COVID-19, and to provide a foundation upon which to
target vaccines and therapeutics to appropriate individuals by
precision medicine.
The two principal investigators for the collaboration are Ilya
Trakht, Ph.D., Associate Research Scientist and Sergei Rudchenko,
Ph.D., Assistant Professor of Medical Sciences at Columbia
University Vagelos College of Physicians and Surgeons. Dr. Trakht’s
project will study T cell and antibody responses in a variety of
ways, including at the cellular level by stimulating T cells in
vitro with CoV-2 antigens and by generating fully human monoclonal
antibodies against CoV-2. The project, directed by Dr. Trakht, has
the potential to lead to the isolation and characterization of
therapeutically relevant fully human monoclonal antibodies to
CoV-2. Dr. Rudchenko’s project will generate DNA aptamer-based
anti-idiotypes to certain of the monoclonal antibodies identified
by Dr. Trakht. Such aptamers have the potential to identify
biomarkers for protective CoV-2 immunity and to lead to accelerated
precision medicine-driven vaccines designed to protect against
COVID-19.
Seth Lederman, M.D., President and Chief Executive Officer of
Tonix Pharmaceuticals, said, “We expect that more than one COVID-19
vaccine will ultimately be approved by the Food and Drug
Administration (FDA), and a challenge for future research will be
to determine which vaccine is appropriate for each individual. Data
from this collaboration will provide a roadmap and tools to
potentially guide these recommendations. This work may also guide
the selection of appropriate individuals for COVID-19 vaccine
trials, such as for Tonix’s TNX-1800, based on a live replicating
vector platform, which is designed to confer durable T cell
immunity. It is also possible that new COVID-19 vaccines can
designed which will be tailored to individuals by precision
medicine. We are excited to work with our collaborators at Columbia
University on these precision medicine technologies and also to
potentially develop new monoclonal antibody therapeutics.”
Dr. Trakht said, “T cell responses to SARS-CoV-2 have only
recently been reported, so there is much that we hope to learn and
to contribute to the understanding of the systemic immune response
to COVID-19. We are excited to exploit our fully human monoclonal
antibody system to characterize the antibody response to SARS-CoV-2
infection and the potential for developing antibody-based
immunotherapeutics."
Dr. Rudchenko said, “The anti-idiotype aptamer tools that we
plan to develop will characterize the immune responses in healthy
people who have recovered or were asymptomatic from SARS-CoV-2
infection, which are relevant for developing therapeutics and
vaccines. A goal for future research will be to use these tools to
distinguish SARS-CoV-2-specific immunity in COVID-19 patients who
suffered poor outcomes. My colleague, Dr. Trakht’s system to make
human monoclonal antibodies is particularly well suited to evaluate
individuals’ antibody responses at a high level of detail in the
context of accelerating precision medicine approaches to vaccines
and therapeutics.”
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*, a second live replicating vaccine candidate 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. 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 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-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; 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
Jessica Morris (corporate)Tonix
Pharmaceuticalsinvestor.relations@tonixpharma.com(212) 688-9421
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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