Celsion Corporation Highlights Pipeline Progress in Its Lead Development Candidates
May 10 2022 - 8:30AM
Celsion Corporation (NASDAQ: CLSN), a clinical-stage company
focused on DNA-based immunotherapy and next-generation vaccines,
today provided an update on the progress made in the Company’s two
lead development programs.
“We continue to make important progress in both
of our lead development programs, and I am very pleased by the
encouraging results to date,” said Michael H. Tardugno, chairman,
president and chief executive officer of Celsion. “Our PLACCINE
DNA-based vaccine platform was recently highlighted at the 2022
World Vaccine Congress and is demonstrating its potential for rapid
design and capability for targeting two or more different COVID
variants in one vaccine. We have demonstrated a proof-of-concept
utilizing a standard mouse model showing that PLACCINE can target
two variants and produce robust levels of IgG, neutralizing
antibodies, and t-cell responses. This proof-of-concept data is
comparing favorably to commercial vaccines in mouse models with
this data recently reported at the World Vaccine Congress. A
vaccine that targets multiple strains at once and designed to
provide long lasting immunity, is important in a future COVID-19
vaccination strategy. We are moving this program forward quickly
and anticipate confirming our proof-of-concept in non-human
primates over the next several months, with durability results
later this year.”
Mr. Tardugno continued, “OVATION 2, the Phase II
study of our GEN-1 immunotherapy in ovarian cancer is 85% enrolled.
In spite of all of the challenges presented by COVID 19, we are
hopeful to complete enrollment in the third quarter of this year.
Preclinical and clinical data gives us every reason to believe in
GEN-1’s promise for ovarian cancer patients along with the support
from leading medical researchers of the Gynecological Oncology
Group (GOG). The GOG’s interest in forging a partnership to develop
GEN-1 in ovarian cancer will assist Celsion in its plans for an
accelerated registrational program. Meanwhile, FDA has approved our
protocol for a second Phase II clinical trial to evaluate GEN-1 in
combination with Avastin® (bevacizumab) in patients with advanced
ovarian cancer. Our preclinical tumor inhibition data provides a
convincing basis for this study. We look forward to initiating this
study at major comprehensive cancer hospitals later this year.”
About PLACCINE
PLACCINE is a first in class DNA vaccine
platform that can target multiple antigens and be administered with
a standard intramuscular injection. PLACCINE was derived from the
Company’s proprietary TheraPlas platform.
About GEN-1
GEN-1, an IL-12 DNA plasmid vector formulated
into nanoparticles with a lipopolymeric delivery system, is the
first product designed via the TheraPlas platform technology. GEN-1
may prove to be a safe and effective immunotherapy for treating
various types of tumors by producing high levels of interleukin-12
(IL-12) at the site of tumors. IL-12 is one of the most active
cytokines for stimulating an immune response against cancer.
However, when administered as a recombinant protein requiring
systemic administration, the pharmacokinetics of IL-12 requires
that it be given by frequent, large bolus injections, resulting in
serious toxicities that limit its use. GEN-1 addresses the toxicity
issues associated with systemic IL-12. GEN-1’s nanoparticle design
enables local administration (into the abdominal cavity) and cell
transfection followed by persistent, local secretion of IL-12 at
therapeutic levels, while avoiding the toxicities associated with
recombinant IL-12.
About Celsion
Corporation
Celsion is a fully integrated, clinical
stage biotechnology company focused on advancing a portfolio of
innovative cancer treatments, including immunotherapies and
DNA-based therapies; and a platform for the development of nucleic
acid vaccines currently focused on SARS-CoV2. The company’s product
pipeline includes GEN-1, a DNA-based immunotherapy for the
localized treatment of ovarian cancer. Celsion’s wholly owned
subsidiary, Celsion GmbH, is managing ThermoDox®, a proprietary
heat-activated liposomal encapsulation of doxorubicin, which is
under investigator-sponsored development for several cancer
indications. For more information on Celsion,
visit www.celsion.com and www.celsiongmbh.com.
Forward-Looking Statements
Celsion wishes to inform readers that
forward-looking statements in this 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 Celsion to
evaluate its future development plans; possible acquisitions or
licenses of other technologies, assets or businesses; possible
actions by customers, suppliers, competitors, regulatory
authorities; and other risks detailed from time to time
in Celsion's periodic reports and prospectuses filed 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
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