Tonix Pharmaceuticals Expands Research Collaboration to Develop Precision Medicine Techniques for COVID-19 Vaccines and Therapeutics
September 23 2021 - 7:00AM
Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the
Company), a clinical-stage biopharmaceutical company, today
announced it has expanded its research collaboration with Columbia
University. The research collaboration is focused on studying
immune responses to COVID-19 in healthy volunteers who have
recovered from COVID-19 or were asymptomatic, as well as studying
in vitro T cell and antibody responses to SARS-CoV-2, the virus
that causes COVID-19. The research is designed to fill in important
gaps in understanding the detailed immune responses to COVID-19,
and to provide a foundation for tailoring vaccines and therapeutics
to appropriate individuals with 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 is studying 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 SARS-CoV-2. This research
has the potential to lead to the isolation, characterization and
cloning of therapeutically relevant fully human neutralizing
monoclonal antibodies to SARS-CoV-2.
Dr. Rudchenko is generating DNA aptamer-based
anti-idiotypes to certain monoclonal antibodies identified by Dr.
Trakht. Such aptamers have the potential to identify biomarkers for
protective CoV-2 immunity and accelerate the design of precision
medicine-driven vaccines against COVID-19.
“Based on the progress and results of the
initial phase of these projects, we are excited to expand our
research collaboration with Columbia University on these precision
medicine technologies and also to potentially develop new
monoclonal antibody therapeutics,” stated Seth Lederman, M.D.,
President and Chief Executive Officer of Tonix. “Data from this
collaboration may provide a roadmap and tools to potentially guide
the selection of appropriate individuals for COVID-19 vaccine
trials and to help determine which vaccine is appropriate for each
individual based on the condition of their immune system or other
physiological features.”
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
immunology and central nervous system (CNS) product candidates.
Tonix’s immunology portfolio includes a COVID-19 platform of
product candidates to prevent and treat COVID-19, to treat Long
COVID as well as to detect functional T cell immunity to COVID-19.
Tonix’s lead vaccine candidate for COVID-19, TNX-18001, 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 reported positive efficacy data from animal studies of
TNX-1800 in the first quarter of 2021 and expects to start a Phase
1 study in humans in the first half of 2022. TNX-35002
(sangivamycin) is a small molecule antiviral drug to treat acute
COVID-19 and is in the pre-Investigational New Drug (IND) stage of
development. TNX-102 SL3 (cyclobenzaprine HCl sublingual tablets)
is a small molecule drug being developed to treat Long COVID, a
chronic condition, and is also in the pre-IND stage. Finally, Tonix
is developing TNX-2100, an in vivo diagnostic to measure the
presence of functional T cell immunity to COVID-19. Tonix intends
to initiate a first-in-human clinical study of TNX-21004 in the
fourth quarter of 2021, pending IND clearance. Tonix’s immunology
portfolio also includes biologics to address immunosuppression,
cancer, and autoimmune diseases. The Company’s CNS portfolio
includes both small molecules and biologics to treat pain,
neurologic, psychiatric and addiction conditions. Tonix’s lead CNS
candidate, TNX-102 SL3, is in mid-Phase 3 development for the
management of fibromyalgia.
1TNX-1800 is an investigational new biologic and
has not been approved for any indication. TNX-1800 is based on
TNX-801, live horsepox virus vaccine for percutaneous
administration, which is in development to protect against smallpox
and monkeypox.2TNX-3500 is an investigational new drug at the
pre-IND stage of development and has not been approved for any
indication.3TNX-102 SL is an investigational new drug and has not
been approved for any indication.4TNX-2100 is an investigational
new biologic and has 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 our research collaboration efforts, 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, 2020, as filed with the Securities and
Exchange Commission (the “SEC”) on March 15, 2021, and periodic
reports filed with the SEC on or after the date thereof. All
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(862) 904-8182
Olipriya Das, Ph.D. (media)Russo
PartnersOlipriya.Das@russopartnersllc.com (646) 942-5588
Peter Vozzo
(investors)Westwicke/ICRpeter.vozzo@westwicke.com(443) 213-0505
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