IMUNON Unveils New Manufacturing Capabilities at Huntsville’s HudsonAlpha Biotech Campus
2023年6月28日 - 1:00AM
IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage biotechnology
company, today unveiled its new current Good Manufacturing
Practices (cGMP) clinical materials production facility, located on
the Huntsville campus of the HudsonAlpha Institute for
Biotechnology. The facility is intended to provide IMUNON with
additional control over the quantities and costs of manufacturing
non-viral DNA-based materials used in its research and development
(R&D) activities.
Dr. Corinne Le Goff, president and chief
executive officer of IMUNON, said, “The opening of this new
facility is an important step forward that enables IMUNON to
advance significant research and clinical development activities in
non-viral DNA-medical technologies. We are proud to reach this
important production capability milestone, building on the
expansive research campus of HudsonAlpha Institute. This new
capability complements the company’s cGMP quality control facility
for testing our clinical products at the Huntsville site.”
Dr. Khursheed Anwer, IMUNON executive vice
president & chief science officer, said, “IMUNON has designed
and built our own manufacturing capabilities to produce GMP-grade
plasmid DNA (pDNA) and DNA facilitating agents to support
Phase 1 clinical studies for our PlaCCine infectious disease
modality and our IndiPlas and FixPlas cancer vaccine
modalities."
He added, “The new facility’s specifications
follow the 2008 FDA guidance cGMP for Phase 1 investigational
drugs. The pDNA and DNA facilitating agents are the key components
of the final vaccine formulation for which GMP fill & finish is
carried out at a CDMO partner site. IMUNON’s GMP facility can
support batch sizes of up to 80,000 vials.”
Dr. Le Goff added, “Investing in our core
capabilities is a key component of our business model, allowing us
to control cost, quality and timelines. IMUNON’s team has extensive
experience manufacturing DNA medicines, which is very attractive
for current and potential partners. We notably have a major
collaborative effort in ovarian cancer with the Break Through
Cancer Foundation to determine the clinical benefits of our
IMNN-001 in combination with bevacizumab in ovarian cancer in the
frontline, neoadjuvant setting.”
Jim Hudson, co-founder of HudsonAlpha Institute
for Biotechnology, said, “IMUNON’s new capabilities complement the
work being performed across HudsonAlpha's Biotech Campus. Since the
Institute opened in 2008, the IMUNON team has been a valuable part
of the HudsonAlpha ecosystem. We are excited about today's news and
for IMUNON's future in Huntsville."
About IMUNON
IMUNON is a fully integrated, clinical stage
biotechnology company focused on advancing a portfolio of
innovative treatments that harness the body’s natural mechanisms to
generate safe, effective and durable responses across a broad array
of human diseases, constituting a differentiating approach from
conventional therapies.
IMUNON has two platform technologies: the
TheraPlas modality for the development of immunotherapies and other
anti-cancer nucleic acid-based therapies, and the PlaCCine modality
for the development of nucleic acid vaccines for infectious
diseases and cancer. The Company’s lead clinical program, IMNN-001,
is a DNA-based immunotherapy for the localized treatment of
advanced ovarian cancer currently in Phase 2 development. IMNN-001
works by instructing the body to produce safe and durable levels of
powerful cancer-fighting molecules, such as interleukin-12 and
interferon gamma, at the tumor site. Additionally, the Company is
conducting preclinical proof-of-concept studies on a nucleic acid
vaccine candidate targeting the SARS-CoV-2 virus to validate its
PlaCCine platform. IMUNON’s platform technologies are based on the
delivery of nucleic acids with novel synthetic delivery systems
that are independent of viral vectors or devices. IMUNON will
continue to leverage these platforms and to advance the
technological frontier of nucleic acid-based products to better
serve patients with difficult-to-treat conditions. For more
information on IMUNON, visit www.imunon.com.
About HudsonAlpha
HudsonAlpha Institute for Biotechnology is a
nonprofit institute dedicated to developing and applying scientific
advances to health, agriculture, education and commercialization.
The HudsonAlpha biotechnology campus consists of 152 acres nestled
within Cummings Research Park, the nation’s second-largest research
park. The state-of-the-art facilities co-locate nonprofit
scientific researchers with entrepreneurs and educators.
HudsonAlpha is a national and international leader in genetics and
genomics research and biotech education and fosters more than 45
diverse biotech companies on campus.
Forward-Looking Statements
IMUNON wishes to inform readers that
forward-looking statements in this news release are made pursuant
to the “safe harbor” provisions of the Private Securities
Litigation Reform Act of 1995. Readers are cautioned that such
forward-looking statements involve risks and uncertainties
including, without limitation, unforeseen changes in the course of
research and development activities and in clinical trials; the
uncertainties of and difficulties in analyzing interim clinical
data; the significant expense, time and risk of failure of
conducting clinical trials; the need for IMUNON to evaluate its
future development plans; possible acquisitions or licenses of
other technologies, assets or businesses; possible actions by
customers, suppliers, competitors or regulatory authorities; and
other risks detailed from time to time in IMUNON’s periodic reports
and prospectuses filed with the Securities and Exchange Commission.
IMUNON assumes no obligation to update or supplement
forward-looking statements that become untrue because of subsequent
events, new information or otherwise.
Contacts:
IMUNON |
LHA Investor Relations |
Jeffrey W. Church |
Kim Sutton Golodetz |
Executive Vice President, CFO |
212-838-3777 |
and Corporate Secretary |
Kgolodetz@lhai.com |
609-482-2455 |
|
jchurch@imunon.com |
|
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