Full Press Release Details
Tonix Pharmaceuticals Holding Corp. 8-K
Pharmaceuticals Announces Completion of Acquisition of Infectious Disease R&D Center in Frederick, Maryland
Center is Expected to Accelerate Internal Discovery and Development of Vaccines and Antiviral Drugs Against COVID-19,
Other Infectious Diseases
R&D Capability for Vaccines and Antivirals Intended to Support U.S. Pandemic Preparedness
N.J., October 4, 2021 (GLOBE NEWSWIRE) - Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage
biopharmaceutical company, announced it has completed the acquisition of its new research and development center (RDC) located in Frederick,
Md. The approximately 48,000 square foot facility will support Tonix's expanding infectious disease pipeline, including:
purchased the RDC from Southern Research, a collaborating partner on TNX-1800 and TNX-801 development.
center is operational with a dedicated staff of scientists and technicians. The main building was constructed as a biosafety level (BSL)
-3 facility but has been operating at BSL-2. Tonix plans to make appropriate upgrades and seek certification for BSL-3 so that research
may be conducted on live SARS-CoV-2- and other pathogens.
RDC in Frederick, Md. will complement Tonix's Advanced Development Center (ADC) being constructed in New Bedford, Mass., and its
Commercial Manufacturing Center (CMC) planned in Hamilton, Mont. The ADC will house laboratories dedicated to process analytical development
and pilot manufacturing of the Company's vaccine candidates for clinical trials. The CMC is expected to support commercial scale
manufacturing of vaccine products.
establishment of the RDC is a significant milestone for Tonix and aligns with our strategic focus to support and grow our pipeline of
vaccines and antiviral therapeutics," stated Seth Lederman, M.D., President and Chief Executive Officer of Tonix. "We believe
that this strategy will enable Tonix to develop vaccines and therapeutics to address the current COVID-19 pandemic, and to be prepared
to efficiently combat potential novel or emerging pathogens, termed Disease X', that could impact society in the future.
We believe that the recombinant pox virus platform technology underlying TNX-1800 and TNX-801, coupled with our capabilities at the RDC
and ADC, will be rapidly deployable for addressing Disease X, with simplified distribution and administration, relative to modified mRNA
based vaccines. Our goal is to be able to design and test new recombinant pox virus vaccines against novel pathogens within the 100 days
of recognition of a potential emerging pandemic threat, consistent with the criteria1,2 recently set forth by the White House
Office of Science and Technology Policy."
Tonix Pharmaceuticals Holding Corp.
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 Tonix's recombinant pox vaccine (RPV) 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-21004, 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.
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.
is an investigational new drug at the pre-IND stage of development and has not been approved for any indication.
SL is an investigational new drug and has not been approved for any indication.
is an investigational new biologic 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, the risks related
to operating research, development and manufacturing facilities, 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 Pharmaceuticals
Olipriya Das, Ph.D. (media)
Peter Vozzo (investors)
Westwicke, an ICR Company