Celsion Reports Data Safety Monitoring Board Recommendation to Continue Dosing Patients in the Phase II Portion of the OVATIO...
July 19 2021 - 8:00AM
Celsion Corporation (NASDAQ: CLSN), a clinical-stage company
focused on DNA-based immunotherapy and next-generation vaccines,
today announced that following a pre-planned interim safety review
of 55 as treated patients randomized in the Phase I/II OVATION 2
Study with GEN-1 in advanced (Stage III/IV) ovarian cancer, the
Data Safety Monitoring Board (DSMB) has unanimously recommended
that the OVATION 2 Study continue treating patients with the dose
of 100 mg/m2. The DSMB also determined that safety is satisfactory
with an acceptable risk/benefit, and that patients tolerate up to
17 doses of GEN-1 during a course of treatment that lasts up to six
months. No dose-limiting toxicities were reported.
The OVATION 2 Study combines GEN-1, the
Company's IL-12 gene-mediated immunotherapy, with standard-of-care
neoadjuvant chemotherapy (NACT) in patients newly diagnosed with
Stage III/IV ovarian cancer. NACT is designed to shrink the cancer
as much as possible for optimal surgical removal after three cycles
of chemotherapy. Following NACT, patients undergo interval
debulking surgery, followed by three additional cycles of
chemotherapy to treat any residual tumor.
The OVATION 2 Study is designed with an 80%
confidence interval for an observed Progression Free Survival (PFS)
Hazard Ratio of 0.75, which would mean an approximate 33%
improvement in risk for cancer progression when comparing the
treatment arm (NACT + GEN-1) with the control arm (NACT only).
GEN-1 is an immunotherapy that produces safe and durable local
levels of IL-12, a pluripotent cytokine associated with the
stimulation of innate and adaptive immune response against cancer.
The GEN-1 nanoparticle comprises a DNA plasmid encoding IL-12 gene
and a synthetic polymer facilitating plasmid delivery vector. Cell
transfection is followed by persistent, local secretion of the
IL-12 protein at therapeutic levels.
The Company also announced that more than 50% of
the projected 110 patients have been enrolled in the OVATION 2
Study. Interim clinical data from the first 36 patients who have
undergone interval debulking surgery are as follows:
- Of the 36
patients who have undergone interval debulking surgery in the
OVATION 2 Study:
- 20 patients
were treated with GEN-1 at a dose of 100 mg/m² plus NACT, with 16
out of 20 patients (80%) having a complete tumor resection (R0),
which indicates a microscopically margin-negative resection in
which no gross or microscopic tumor remains in the tumor bed;
and
- 16 patients
were treated with NACT only, with 9 out of 16 patients (56%) having
R0 resections.
- When combining
these results with the surgical resection rates observed in the
Company’s prior Phase Ib dose-escalation trial (the OVATION 1
Study), a population of patients with inclusion criteria identical
to the OVATION 2 Study, the data reflect the strong dose-dependent
efficacy of adding GEN-1 to NACT:
|
|
% Patients with
R0
Resections |
0, 36, 47 mg/m² of GEN-1 plus NACT |
n=22 |
50 |
% |
61, 79, 100 mg/m² of GEN-1 plus NACT |
n=28 |
82 |
% |
- The objective response rate (ORR)
as measured by Response Evaluation Criteria in Solid Tumors
(RECIST) criteria for the 16 patients treated with NACT only were
comparable, as expected, to the 20 patients treated with GEN-1 at a
dose of 100 mg/m² plus NACT, with both groups demonstrating an
approximate 80% ORR.
“These findings show a consistent dose-dependent
clinical response in both surgical outcome and tumor response,
which is further supported by translational data of the tumor
microenvironment,” noted Nicholas Borys, M.D., Celsion’s executive
vice president and chief medical officer. “Continuing our clinical
research program at the 100 mg/m2 dose in patients with
advanced-stage ovarian cancer holds promise and is strongly
encouraged by our study investigators and medical advisors.”
“We thank the DSMB members for their work and
advice,” said Michael H. Tardugno, Celsion’s chairman, president
and chief executive officer. “We are encouraged by the current rate
of patient recruitment and expect to complete enrollment around the
end of this year. FDA Fast Track and Orphan Drug Designations for
GEN-1 in advanced ovarian cancer are important for our future
commercialization efforts. In addition, under the Biologics Price
Competition and Innovation Act of 2009, sponsors of new, licensed
biological products like GEN-1 that are approved through a
Biologics License Application receive 12 years of market
exclusivity. The FDA cannot license any 351(k) application for a
biosimilar or interchangeable product that relies on the previously
approved product as a reference for biosimilarity during this
12-year period.”
In February 2021, the Company announced that
GEN-1 received FDA Fast Track Designation in advanced ovarian
cancer. Celsion plans to request FDA Breakthrough Therapy
Designation for GEN-1 based on the encouraging clinical data
announced today.
About GEN-1 Immunotherapy
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. The Company previously reported positive safety and
encouraging Phase I results with GEN-1 given as monotherapy or a
combination therapy in patients with advanced peritoneally
metastasized primary or recurrent ovarian cancer, and recently
completed a Phase Ib dose-escalation trial (OVATION 1 Study) of
GEN-1 in combination with carboplatin and paclitaxel in patients
with newly diagnosed ovarian cancer.
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-CoV-2. 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
investigator-sponsored development for several cancer indications.
Celsion also has two platform technologies for the development of
novel nucleic acid-based immunotherapies and other anticancer 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 www.celsion.com.
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. Church, EVP, CFO and Corporate
Secretary609-482-2455jchurch@celsion.com |
LHA Investor
RelationsKim Sutton
Golodetz212-838-3777kgolodetz@lhai.com |
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