Celsion Corporation Files Provisional U.S. Patent Application for a Broad Range of Next Generation DNA Vaccines
January 28 2021 - 8:00AM
Celsion Corporation (NASDAQ: CLSN), a clinical stage biotechnology
company, in response to the long-term threat of coronaviruses and
other potential pandemic causing infectious agents, today announced
the filing of a provisional U.S. patent application for a novel
DNA-based, investigational vaccine for preventing or treating
infections from a broad range of infectious agents including the
coronavirus disease using its PLACCINE DNA vaccine technology
platform. The provisional patent covers a family of novel
composition of multi-cistronic vectors and polymeric nanoparticles
that comprise the PLACCINE DNA vaccine platform technology for
preventing or treating infectious agents that have the potential
for global pandemics, including the SARS-CoV-2 virus and its
variations, using the Company’s platform technology. PLACCINE is a
natural extension of the Company’s synthetic, non-viral TheraPlas
delivery technology currently in a Phase II trial for the treatment
of late-stage ovarian cancer with GEN-1, Celsion’s DNA-mediated
IL-12 immunotherapy.
Celsion’s vaccine approach is designed to
optimize the quality of the immune response dictating the
efficiency of pathogen clearance and patient recovery. Celsion has
taken a multivalent approach in an effort to generate an even more
robust immune response that not only results in a strong
neutralizing antibody response, but also a more robust and durable
T-cell response. Delivered with Celsion’s synthetic polymeric
system, the proprietary DNA plasmid is protected from degradation
and its cellular uptake is facilitated.
Khursheed Anwer, Ph.D., Executive Vice President
and Chief Scientific Officer at Celsion, said, “This patent, if
granted, provides protection to expand upon our synthetic,
non-viral TheraPlas delivery technology to produce potentially
broad and long-lasting robust antibody-mediated protection against
infectious agents with pandemic potential, coupled with a
simultaneous expression of IL-12, an essential regulator of the
differentiation, proliferation and maintenance of T helper 1 cells.
These cells lead to the generation of killer T-cells and memory
T-cells against virally infected cells that may boost the viral
clearance provided by the vaccine and improve the memory of the
immune system against any future exposure to the same virus and
maintain robust immunity in the face of future mutations.”
Celsion's proprietary multifunctional DNA
vaccine technology concept is built on the flexible PLACCINE
technology platform that is amenable to rapidly responding to the
SARS-CoV-2 virus, as well as possible future mutations of
SARS-CoV-2, other future pandemics, emerging bioterrorism threats,
and novel infectious diseases. Celsion’s extensive experience with
TheraPlas suggests that the PLACCINE-based nanoparticles are stable
at storage temperatures of 4oC to 25oC, making vaccines developed
on this platform easily suitable for broad world-wide
distribution.
Michael H. Tardugno, Celsion’s Chairman,
President and Chief Executive Officer, noted that “Celsion’s
PLACCINE DNA vaccine technology platform is characterized by a
single plasmid DNA with multiple coding regions. The plasmid vector
is conceived to express multiple pathogen antigens along with a
potent immune modifier. It is delivered via a synthetic delivery
system and has the potential to be easily adaptable to create
vaccines against a multitude of pathogens, including emerging
pathogens leading to pandemics and those infectious diseases that
cannot be addressed by current technologies due to poor
efficiency.”
About Celsion
Corporation
Celsion is a fully integrated, clinical stage
biotechnology company focused on advancing a portfolio of
innovative cancer treatments, including immunotherapies, DNA-based
therapies and directed chemotherapies through clinical trials and
eventual commercialization. The Company’s product pipeline includes
GEN-1, a DNA-based immunotherapy for the localized treatment of
ovarian cancer. ThermoDox®, a proprietary heat-activated liposomal
encapsulation of doxorubicin, is under review for continued patient
Overall Survival following a futility assessment by the independent
Data Management Committee in its Phase III study of primary liver
cancer. ThermoDox® is also under investigator-sponsored development
for other cancer indications. Celsion has two feasibility stage
platform technologies for the development of novel nucleic
acid-based immunotherapies and other anti-cancer DNA or RNA
therapies. Both are novel synthetic, non-viral vectors with
demonstrated capability in nucleic acid cellular transfection. For
more information on Celsion, visit: http://www.celsion.com.
Forward-looking Statements
Forward-looking statements in this news release
are made pursuant to the "safe harbor" provisions of the Private
Securities Litigation Reform Act of 1995. These statements are
based upon current beliefs, expectation, and assumptions and
include statements regarding the platform having the potential to
provide broad protection against COVID-19, and possible future
mutations of SARS-CoV-2 or other coronaviruses. These statements
are subject to a number of risks and uncertainties, many of which
are difficult to predict, including the ability of the Company’s
platform to provide broad protection against COVID-19, and possible
future mutations of SARS-CoV-2 or other coronaviruses, the issuance
of a patent to the Company for use of its technology platform for
treating or preventing infection with the SARS-CoV-2 virus that
causes coronavirus disease 2019 (COVID-19), unforeseen changes in
the course of research and development activities and in clinical
trials; the uncertainties of and difficulties in analyzing interim
clinical data, particularly in small subgroups that are not
statistically significant; FDA and regulatory uncertainties and
risks; the significant expense, time and risk of failure of
conducting clinical trials; the need for Celsion 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 the Celsion's periodic
filings with the Securities and Exchange Commission. Celsion
assumes no obligation to update or supplement forward-looking
statements that become untrue because of subsequent events, new
information or otherwise.
Celsion Investor ContactJeffrey
W. ChurchExecutive Vice President and
CFO609-482-2455jchurch@celsion.com
LHA Investor RelationsKim
Sutton Golodetz212-838-3777kgolodetz@lhai.com
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