Tonix Pharmaceuticals Announces Completion of Acquisition of Infectious Disease R&D Center in Frederick, Maryland
October 04 2021 - 07:00AM
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:
- TNX-1800 - a live virus vaccine
designed to protect against COVID-19
- TNX-801 - a live virus vaccine
designed to protect against smallpox and monkeypox
- TNX-3500 - a small molecule
antiviral under development to treat COVID-19
- TNX-2100 - a peptide based skin
test to measure functional T cell immunity to SARS-CoV-2
Tonix purchased the RDC from Southern Research,
a collaborating partner on TNX-1800 and TNX-801 development.
The 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.
The 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.
“The 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.”
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/
About 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.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 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.
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)Westwicke, an ICR
Companypeter.vozzo@westwicke.com (443) 213-0505
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