Tonix Pharmaceuticals Announces Groundbreaking Ceremony for Massachusetts R&D Facility to House the Advanced Development Center (ADC) for Vaccine Programs
August 02 2021 - 7:00AM
Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the
Company), a clinical-stage biopharmaceutical company, today
announced it will hold a groundbreaking ceremony at the Company’s
planned 45,000 square foot clinical scale manufacturing facility in
the New Bedford Business Park in Massachusetts on August 3, 2021 at
11:00 a.m. ET. The new facility is expected to house Tonix’s
Advanced Development Center (ADC) for accelerated research,
development and analytical capabilities, as well as the production
of clinical trial quality vaccines for infectious diseases,
including COVID-19. The ceremony marks the formal start of site
construction. Tonix expects the facility to be operational in the
first half of 2022.
Plans for the ADC include single-use bioreactors
and purification suites with equipment for Good Manufacturing
Practice (GMP) production of vaccines for clinical trials,
including when fully operational, the capability of producing
sterile vaccines in glass bottles. The ADC is intended to be
Biosafety Level 2 (BSL-2). At full capacity, the facility can
employ up to 70 researchers, scientists, manufacturing and
technical support staff.
U. S. Representative Bill Keating is expected to
attend the event, along with Massachusetts Housing and Economic
Development Secretary, Mike Kennealy, the mayor of New Bedford, Jon
Mitchell, and Seth Lederman, M.D., President and Chief Executive
Officer of Tonix.
“The South Coast is fast becoming a significant
player in biotech in Massachusetts, and Tonix Pharmaceuticals'
decision to open the Advanced Development Center within the New
Bedford Business Park is a positive indicator of future economic
growth throughout the region,” said Congressman Bill Keating.
“Tonix Pharmaceuticals is bringing good jobs to our region, and I
look forward to watching their growth as the local economy
continues to benefit from increased investment on the South Coast,
including in South Coast Rail. The research, development, and
manufacturing planned to take place in the new ADC has the
potential to improve lives all over the world, and that is
something we can all be proud of.”
“We welcome Tonix Pharmaceuticals to the New
Bedford Business Park as they strive to develop important solutions
that address the health challenges of today and tomorrow,” said Jon
Mitchell, mayor of the City of New Bedford.
“The ADC is expected to greatly enhance our
internal capacity for development activities, but, even more
importantly, add a manufacturing capability for clinical trial
quality vaccines. We at Tonix are grateful to the Town of Dartmouth
for their support. We also thank the City of New Bedford for its
cooperation with the Town of Dartmouth on this project,” stated Dr.
Lederman. “The initiation of construction is a significant
milestone in ultimately adding to our competitive advantage in
responding quickly to emerging infectious diseases utilizing our
growing range of vaccine technologies and protein-based therapeutic
platforms.”
The facility is located in the New Bedford
Business Park in a section of the park that is located in the Town
of Dartmouth, Massachusetts. The two municipalities work together
to accommodate businesses located in the Dartmouth portion of the
park as the roads are inaccessible through Dartmouth and municipal
services are provided by the City of New Bedford.
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
central nervous system (CNS) and immunology product candidates. 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, is in mid-Phase 3
development for the management of fibromyalgia. Tonix’s immunology
portfolio includes vaccines to prevent infectious diseases and
biologics to address immunosuppression, cancer, and autoimmune
diseases. Tonix’s lead vaccine candidate, TNX-18002, is a live
replicating vaccine based on the horsepox viral vector 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. TNX-8012, live horsepox
virus vaccine for percutaneous administration, is in development to
protect against smallpox and monkeypox. TNX-35003 (sangivamycin) is
a small molecule antiviral drug in the pre-IND stage of
development.
1TNX-102 SL is an investigational new drug and
has not been approved for any indication.
2TNX-1800 and TNX-801 are investigational new
biologics and have not been approved for any indication.
3TNX-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 and operation of the ADC, 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/ICRpeter.vozzo@westwicke.com(443) 213-0505
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