Tonix Pharmaceuticals Announces Publication of Paper on Antiviral SARS-CoV-2 Inhibitor, TNX-3500, in JCI Insight
November 22 2021 - 4:05PM
Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the
Company), a clinical-stage biopharmaceutical company, today
announced the publication of “Sangivamycin is highly effective
against SARS-CoV-2 in vitro and has favorable drug properties,” in
JCI Insight. The paper includes in vitro studies that show
sangivamycin, the active pharmaceutical ingredient in the Company’s
(TNX-3500) product candidate, is a potent antiviral against
SARS-CoV-2, the cause of COVID-19, and suppresses viral replication
in tissue culture with greater efficacy than remdesivir, the active
pharmaceutical ingredient of Gilead Sciences, Inc.’s Veklury®. When
tested in combination with remdesivir, both drugs had additive
rather than competitive effect against SARS-CoV-2. The new data
show that TNX-3500 has similar low nanomolar antiviral activity in
laboratory-based assays against multiple variants of SARS-CoV-2,
including the Delta variant. The article can be accessed at
https://insight.jci.org/articles/view/153165.
“We are excited to have the results of this
study published, as it demonstrates Tonix’s commitment to helping
fight COVID-19 and other viral disorders,” said Seth Lederman,
M.D., President and Chief Executive Officer of Tonix. “We believe
that TNX-3500’s potency on SARS-CoV-2 inhibition in tissue culture
and its tolerability in humans from prior clinical studies support
the pursuit of TNX-3500 for further clinical development as a
potential COVID-19 therapeutic.”
In April 2021, Tonix entered into an exclusive
worldwide licensing agreement with OyaGen, Inc. (www.oyageninc.com)
to develop TNX-3500 for the treatment of COVID-19 and potentially
other viral infections. OyaGen, Inc. discovered sangivamycin’s
broad-spectrum antiviral effect against Ebola virus, Lassa virus
and orthopoxviruses (https://doi.org/10.3390/v13010052) through a
collaborative research agreement with National Institute of Allergy
and Infectious Disease/National Institute of Health (NIAID/NIH)
Integrated Research Facility (IRF-Frederick) at Fort Detrick,
Maryland, and the recent findings on SARS-CoV-2 are a product of
this collaboration.
Dr. Harold Smith, President and CEO of OyaGen,
Inc. stated, “The findings reported in our paper are exciting and
reveal significant new understanding of the broad-spectrum
antiviral activity of sangivamycin and its in vitro activity. Given
the rapid global spread of the Delta variant of SARS-CoV-2, we are
encouraged that the high potency of sangivamycin against multiple
variants of SARS-CoV-2 may provide a much-needed medical
countermeasure against current and future variants of
coronaviruses. The data produced through a collaborative research
agreement with the IRF-Frederick together with prior safety studies
in cancer clinical trials suggest that TNX-3500 may be effective in
clinical settings and perhaps may enhance the efficacy of other
therapeutics through combination antiviral therapy. We are excited
to be working with Tonix on the development of TNX-3500 for the
treatment of COVID-19.”
Tonix intends to conduct further nonclinical
animal studies prior to submitting an Investigational New Drug
application (IND) and initiating a Phase 1 clinical study.
About Tonix Pharmaceuticals Holding
Corp.
Tonix is a clinical-stage biopharmaceutical
company focused on discovering, licensing, acquiring and developing
therapeutics and diagnostics 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 COVID-19-related product
candidates to prevent and treat COVID-19, to treat Long COVID as
well as to detect functional T cell immunity to SARS-CoV-2. 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 SL1 (cyclobenzaprine HCl
sublingual tablets), is in mid-Phase 3 development for the
management of fibromyalgia. TNX-13002 is a biologic designed to
treat cocaine intoxication that is expected to start a Phase 2
trial before year end. Tonix’s lead vaccine candidate for COVID-19,
TNX-18003, is a live replicating vaccine based on Tonix’s
recombinant pox vaccine (RPV) platform to protect against COVID-19,
primarily by eliciting a T cell response. Tonix expects to start a
Phase 1 study in humans in the second half of 2022. Tonix is also
developing TNX-21004, an in vivo diagnostic to measure
the presence of functional T cell immunity to SARS-CoV-2 and
intends to initiate a first-in-human clinical study.
TNX-35005 (sangivamycin, i.v. solution) is a small molecule
antiviral drug to treat acute COVID-19 and is in the pre-IND stage
of development. Finally, TNX-102 SL is a small molecule drug
being developed to treat Long COVID, a chronic post-COVID
condition, and is also in the pre-IND stage. Tonix expects to
conduct a Phase 2 study in Long COVID in the first half of 2022.
Tonix’s immunology portfolio also includes biologics to address
immunosuppression, cancer, and autoimmune diseases.
1TNX-102 SL is an investigational new drug and
has not been approved for any indication.2TNX-1300 is an
investigational new biologic at the pre-IND stage of development
and has not been approved for any indication.3TNX-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. TNX-801 is
an investigational new biologic and has not been approved for any
indication.4TNX-2100 is an investigational new biologic and has not
been approved for any indication.5TNX-3500 is an investigational
new drug at the pre-IND stage of development 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 the development of TNX-3500, 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.
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)ICR
Westwickepeter.vozzo@westwicke.com (443) 213-0505
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