Full Press Release Details
Pharmaceuticals Holding Corp. 8-K
Pharmaceuticals Announces Publication of Paper on Antiviral SARS-CoV-2 Inhibitor, TNX-3500, in JCI Insight
Studies in vitro Show that TNX-3500 is a Potent Antiviral Against Multiple Variants of SARS-CoV-2, the Cause of COVID-19, and Potentiates
NJ, November 22, 2021 (GLOBE NEWSWIRE) - 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.
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."
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.
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."
intends to conduct further nonclinical animal studies prior to submitting an Investigational New Drug application (IND) and initiating
a Phase 1 clinical study.
Tonix Pharmaceuticals Holding Corp.
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.
SL is an investigational new drug and has not been approved for any indication.
is an investigational new biologic at the pre-IND stage of development and has not been approved for any indication.
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.
is an investigational new biologic and has not been approved for any indication.
is an investigational new drug at the pre-IND stage of development and has not been approved for any indication.
press release and further information about Tonix can be found at www.tonixpharma.com.
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
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.