Celsion Provides Summary of Research and Development Day Held on October 12, 2017
October 18 2017 - 8:30AM
Celsion Corporation (NASDAQ:CLSN), an oncology drug development
company, today provided a summary of GEN-1 immunotherapy-related
presentations made during the Company’s Research and Development
(R&D) Day held on Thursday, October 12, 2017. This
summary is intended to provide easy access to pertinent, top line
information discussed during the conference. A complete
webcast of the presentations are available on Celsion's website at
www.celsion.com under the heading News & Investors / Financial
Events / Featured Events – October 12, 2017 – Celsion to Host
Research and Development Update.
The GEN-1 immunotherapy presentations focused on
the Company's clinical and translational research data from its
OVATION Study, a Phase Ib dose escalating clinical trial combining
GEN-1, the Company's DNA-based immunotherapy, with the standard of
care for the treatment of newly-diagnosed patients with advanced
Stage III/IV ovarian cancer who will undergo neoadjuvant
chemotherapy followed by interval debulking surgery. GEN-1 is an
interleukin-IL-12 (IL-12) DNA plasmid vector formulated as a
nanoparticle in a non-viral delivery system to cause the sustained
local production and secretion of the IL-12 protein loco-regionally
at the tumor site. The lead clinical
investigator for the OVATION Study and leading immuno-oncology
experts from the Roswell Park Cancer Institute presented their
current experience with GEN-1 immunotherapy for the treatment of
ovarian cancer.
- Khursheed Anwer, Ph.D., Celsion’s Executive
Vice President & Chief Scientific Officer, presented the
following:
- GEN-1 immunotherapy is a powerful pro-immune modulator designed
to modulate the tumor microenvironment through the delivery of the
potent immune agent IL-12 into the peritoneal cavity in a local and
persistent manner.
- IL-12 shifts the tumor microenvironment from immune suppressive
to immune activation.
- GEN-1 immunotherapy results in the loco-regional production of
the potent cytokine IL-12 avoiding toxicities and poor
pharmacokinetics associated with systemic recombinant IL-12
protein; lasts up to one week; Dosing can be repeated making GEN-1
immunotherapy ideal for long-term maintenance therapy.
- Premal H. Thaker, M.D., Associate Professor in
Gynecologic Oncology, Washington University School of Medicine, St.
Louis, Missouri presented the final clinical data from the Phase Ib
dose-escalating OVATION Study:
- Neoadjuvant treatment approach to ovarian cancer has been
gaining greater support over the last few years due to safety
benefits; Addition of GEN-1 to neoadjuvant chemotherapy was safe
and well tolerated.
- The R0 margin negative resection score in 64% of patients
treated in the OVATION Study appeared to be higher than what you
see with neoadjuvant chemotherapy alone; R0 score of 100% in the
highest dose group is impressive.
- Progression Free Survival (PFS) of over 14 months in the
as-treated patient population is on a positive trend since only 2
out of 16 patients have progressed to-date.
- The patient population in the OVATION Study was highly advanced
(94% at Stage IIIC – IV); better results are anticipated in a mixed
population trial.
- Richard C. Koya, M.D., Ph.D., Associate
Professor of Oncology and Immunology, Director of the Vector
Development & Production Facility, Associate Director of the
Center for Immunotherapy, Roswell Park Cancer Institute, Center for
Immunotherapy, Buffalo, NY presented the following translational
research data from the OVATION Study:
- GEN-1 treatment when administered in combination with standard
of care increased the levels of immune-stimulatory cytokines and
tumor infiltrating lymphocytes in a manner that is consistent with
the known actions of IL-12.
- There is evidence of GEN-1 activity on T-cell numbers as well
as T-cell function. A dose-dependent increase in IFN-gamma, a
strong mediator of immune response, following the treatment is
impressive. Significant reduction in angiogenic growth
factor, VEGF, is also a good indicator of the IL-12 treatment
effect.
- The decrease in immune suppressive signals and the increase in
the ratio of cytotoxic CD8+ cells to immune suppressive signals
suggest a shift in tumor environment in favor of immune
stimulation. A highly immune suppressive tumor environment is
linked with a worsening of the disease and poor treatment
outcome. A shift in the tumor microenvironment in favor of
immune stimulation following GEN-1 treatment is a positive
indication of the IL-12 treatment effect.
- The modulation of tumor microenvironment in favor of immune
stimulation by GEN-1 raises its potential combination benefits with
other forms of immunotherapies, especially adoptive T-cell
therapy. GEN-1 pre-treatment has potential to improve the
survival and potency of the engineered T-cells, a major limitation
in adoptive T-cell therapies.
About the OVATION Study
The Phase Ib trial was designed to evaluate
weekly intraperitoneal dosing of GEN-1 in combination with
neoadjuvant chemotherapy, the standard of care for patients newly
diagnosed with ovarian cancer. Concurrently with neoadjuvant
chemotherapy, enrolled patients will receive escalating weekly
doses of GEN-1, from levels beginning at 36mg/m², to 47mg/m²,
61mg/m² and 79mg/m² weekly for 8 treatments in total, with interval
debulking surgery to follow. The regimen was primarily evaluated
for its safety and tolerability. GEN-1, designed using
Celsion's proprietary TheraPlas platform technology, is an IL-12
DNA plasmid vector encased in a nanoparticle delivery system, which
enables cell transfection followed by persistent, local secretion
of the IL-12 protein. IL-12 is one of the most active cytokines for
the induction of potent anti-cancer immunity acting through the
induction of T-lymphocyte and natural killer (NK) cell
proliferation.
About Celsion
Corporation
Celsion is a fully-integrated oncology company
focused on developing a portfolio of innovative cancer treatments,
including directed chemotherapies, immunotherapies and RNA- or
DNA-based therapies. The Company's lead program is ThermoDox®, a
proprietary heat-activated liposomal encapsulation of doxorubicin,
currently in Phase III development for the treatment of primary
liver cancer and in Phase II development for the treatment of
recurrent chest wall breast cancer. The pipeline also
includes GEN-1, a DNA-based immunotherapy for the localized
treatment of ovarian and brain cancers. Celsion has two
platform technologies for the development of novel nucleic
acid-based immunotherapies and other anti-cancer DNA or RNA
therapies. For more information on Celsion, visit our
website: http://www.celsion.com. (CLSN-G1 CLSN-OV)
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, 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, regulatory authorities; and other risks
detailed from time to time in the 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 Contact
Jeffrey W. Church Sr. Vice President and CFO 609-482-2455
jchurch@celsion.com
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