Tonix Pharmaceuticals Extends Research Collaboration with the University of Alberta to Develop Antiviral Drugs Against SARS-CoV-2
May 18 2022 - 7:00AM
Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the
Company), a clinical-stage biopharmaceutical company, today
announced it has entered into a license agreement and extended a
research collaboration with the University of Alberta, a leading
Canadian research university, focused on identifying and testing
broad-spectrum antiviral drugs against future variants of
SARS-CoV-2 and other emerging viruses.
“We are excited to extend our collaboration with Tom Hobman,
Ph.D., Professor, Department of Cell Biology, University of
Alberta, and to have exercised an option to license the
technology,” said Seth Lederman, M.D., President and Chief
Executive Officer. “Antiviral therapeutics are needed to mitigate
the effects of SARS-CoV-2 and future coronavirus outbreaks, and
Professor Hobman’s work is designed to facilitate the
identification and testing of novel broad-spectrum antiviral drugs.
SARS-CoV-2 is very sensitive to interferon (IFN) treatment and
therefore, drugs that upregulate IFN production and/or signaling
may reduce virus replication.”
“The research collaboration is focused on the development and
testing of Wnt/β-Catenin signaling pathway inhibitors as
broad-spectrum antivirals against SARS-CoV-2 and other emerging
viruses,” said Professor Tom Hobman. “During the first phase of the
sponsored research, we showed that small molecules that inhibit
this pathway also decrease replication of SARS-CoV-2 genomic RNA
and dramatically reduce infectious viral titers. Drugs in this
class seem to work by inducing peroxisome biogenesis, which in turn
enhance production of Type I and III IFNs when cells detect viral
genetic material. Peroxisomes are key antiviral signaling platforms
that are important for IFN induction and antiviral defense. We
believe this work has the potential to lead to drugs that limit the
spread and disease burden of SARS-CoV-2 and other RNA viruses,
which will support the goal of pandemic preparedness.”
About Tonix Pharmaceuticals Holding
Corp.1
Tonix is a clinical-stage biopharmaceutical company focused on
discovering, licensing, acquiring and developing therapeutics to
treat and prevent human disease and alleviate suffering. Tonix’s
portfolio is composed of central nervous system (CNS), rare
disease, immunology and infectious disease product candidates.
Tonix’s CNS portfolio includes both small molecules and biologics
to treat pain, neurologic, psychiatric and addiction conditions.
Tonix’s lead CNS candidate, TNX-102 SL (cyclobenzaprine HCl
sublingual tablet), is in mid-Phase 3 development for the
management of fibromyalgia with a new Phase 3 study launched in the
second quarter of 2022 and interim data expected in the first
quarter of 2023. TNX-102 SL is also being developed to treat Long
COVID, a chronic post-acute COVID-19 condition. Tonix expects to
initiate a Phase 2 study in Long COVID in the second quarter of
2022. TNX-1300 (cocaine esterase) is a biologic designed to
treat cocaine intoxication that is expected to start a Phase 2
trial in the second quarter of 2022. TNX-1300 has been granted
Breakthrough Therapy Designation by the FDA. Finally, TNX-1900
(intranasal potentiated oxytocin), a small molecule in development
for chronic migraine, is expected to enter the clinic with a Phase
2 study in the second half of 2022. Tonix’s rare disease 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 portfolio
includes biologics to address organ transplant rejection,
autoimmunity and cancer, including TNX-1500 which is a
humanized monoclonal antibody targeting CD40-ligand being developed
for the prevention of allograft and xenograft rejection and for the
treatment of autoimmune diseases. A Phase 1 study of TNX-1500 is
expected to be initiated in the second half of 2022. Tonix’s
infectious disease pipeline consists of a vaccine in development to
prevent smallpox and monkeypox called TNX-801, next-generation
vaccines to prevent COVID-19, and a platform to make fully human
monoclonal antibodies to treat COVID-19. Tonix’s lead vaccine
candidates for COVID-19 are TNX-1840 and TNX-1850, which are live
virus vaccines based on Tonix’s recombinant pox live virus vector
vaccine platform.
1All of Tonix’s product candidates are investigational new drugs
or biologics 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 the
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, 2021, as filed with the Securities and
Exchange Commission (the “SEC”) on March 14, 2022, 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(862) 799-8599
Olipriya Das, Ph.D.
(media)Russo PartnersOlipriya.Das@russopartnersllc.com
(646) 942-5588
Peter Vozzo (investors)ICR
Westwickepeter.vozzo@westwicke.com (443) 213-0505
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