Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the
Company), a clinical-stage biopharmaceutical company, today
announced it will hold a ribbon-cutting ceremony at the Company’s
approximately 48,000 square foot research and development center
(RDC) in Frederick, Md. on October 18, 2021 at 12:00 p.m. ET. The
RDC is expected to support the Company’s expanding infectious
disease pipeline. This includes providing internal capacity to
discover and develop vaccines and antivirals intended to support
U.S. pandemic preparedness.
U.S. Senator for Maryland Ben Cardin and U. S.
Congressman David Trone representing Maryland’s 6th Congressional
District, are expected to speak at the event. Also expected to
attend the event are Maryland Department of Commerce Secretary
Kelly Schulz, Frederick County Executive Jan Gardner, and the Mayor
of Frederick, Md., Michael O’Connor. Seth Lederman, M.D., President
and Chief Executive Officer of Tonix and Anthony Macaluso, PhD,
Executive Vice President, Strategic Development of Tonix will make
comments.
“Maryland’s economy is an innovation economy,
making Tonix and Frederick a great match,” said U.S. Senator Ben
Cardin, a member of the Senate Finance Committee. “I applaud the
decision to bring nearly 50,000 square feet of R&D space to
Frederick and have no doubt that the highly skilled local workforce
will achieve great things there.”
“Tonix Pharmaceuticals does great work in the
biopharmaceutical space and, equally important, brings high-paying
jobs to our community” said Congressman Trone. “We welcome Tonix to
Maryland’s 6th District and look forward to its positive impact in
Frederick.”
“We at Tonix are excited to achieve this
significant milestone in our efforts toward supporting and growing
our pipeline of vaccines and antiviral therapeutics,” stated Dr.
Lederman. “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 our Advanced Development Center
(ADC) for manufacturing, 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.”
The RDC 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.
The RDC in Frederick, Md. will complement
Tonix’s 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.
1https://www.whitehouse.gov/wp-content/uploads/2021/09/American-Pandemic-Preparedness-Transforming-Our-Capabilities-Final-For-Web.pdf2https://www.whitehouse.gov/briefing-room/statements-releases/2021/09/03/fact-sheet-biden-administration-to-transform-capabilities-for-pandemic-preparedness/
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 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.
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. TNX-801 is an investigational new biologic and has
not been approved for any indication.
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, the
risks related to the operation of research 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.
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)ICR
Westwickepeter.vozzo@westwicke.com(443) 213-0505
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