IMUNON Reports Interim Progression-Free Survival and Overall Survival Data in Phase 1/2 OVATION 2 Study in Advanced Ovarian Cancer
September 28 2023 - 8:30AM
IMUNON, Inc. (NASDAQ:
IMNN), a clinical-stage biotechnology company focused on
developing DNA-mediated immunotherapies and next-generation
vaccines, announces interim progression-free survival (PFS) and
overall survival (OS) data with IMNN-001 in its Phase 1/2 OVATION 2
Study. IMNN-001 is the Company’s IL-12 gene-mediated immunotherapy
based on its TheraPlas™ technology. Full enrollment of 110 patients
was reached in September 2022.
OVATION 2 is evaluating the dosing, safety,
efficacy and biological activity of intraperitoneal IMNN-001 in
combination with neoadjuvant chemotherapy (NACT) in patients newly
diagnosed with advanced epithelial ovarian, fallopian tube or
primary peritoneal cancer. NACT is designed to shrink the tumors 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.
As expected for a Phase 1/2 study, the study is
directional and was designed with an 80% confidence interval to
show an approximate 33% improvement in PFS, when comparing the
treatment arm (NACT + IMNN-001) with the control arm (NACT only).
The secondary endpoints include OS, objective response rate (ORR),
pathological response, surgical response and serologic response.
The study was not powered for p values of 0.05. The final readout
of this study is expected by mid-2024. A positive readout would
inform next development steps.
Interim data from the intent-to-treat (ITT)
population being reported today show efficacy trends in PFS,
demonstrating a delay in disease progression in the treatment arm
of approximately 33% compared with the control arm, with the hazard
ratio nearing the required value. Preliminary OS data follows a
similar trend, showing an approximate 9-month improvement in the
treatment arm over the control arm.
Subgroup analyses show patients treated with a
PARP inhibitor (PARPi) as maintenance therapy had longer PFS and OS
if they were also treated with IMNN-001 compared with patients
treated with NACT only. This was not a pre-specified subgroup as
PARP inhibitors were approved after the OVATION 2 Study was
initiated.
- The median PFS in the PARPi + NACT
group and the PARPi + NACT + IMNN-001 group was 15.7 months and
23.7 months, respectively.
- The median OS in the PARPi + NACT
group was 45.6 months and has not yet been reached in the PARPi +
NACT + IMNN-001 group.
While the data is still preliminary, the Company
has concluded at this point that patients treated with a
combination of NACT + PARPi + IMNN-001 appear to have the greatest
benefit and should be the focus of on-going follow up.
IMUNON also continues to see benefits in other
secondary endpoints including an approximately 20% higher R0 tumor
resection score and a doubling of the CRS 3 chemotherapy response
score to approximately 30% in the treatment arm versus 14% in the
control arm. A complete tumor resection (R0) is a microscopically
margin-negative resection in which no gross or microscopic tumor
remains in the tumor bed. Chemotherapy response score is considered
a good prognostic indicator in ovarian cancer. Safety analyses
continue to show good tolerability of IMNN-001 in this setting.
Commenting on the interim data, Dr. Corinne Le
Goff, IMUNON’s president and chief executive officer, said, “We are
encouraged by these interim results and are particularly intrigued
by the overall survival trends in the subgroup of patients who
received PARP inhibitors, neoadjuvant chemotherapy and IMNN-001.
While the number of patients in this subgroup is relatively small,
this regimen may hold potential in treatment strategies as we
continue to monitor patients enrolled in OVATION 2, with
expectations to report topline results in mid-2024.”
About IMNN-001
Immunotherapy
Designed using IMUNON's proprietary TheraPlas
platform technology, IMNN-001 is an IL-12 DNA plasmid vector
encased in a nanoparticle delivery system that 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 anticancer immunity acting through the
induction of T-lymphocyte and natural killer cell proliferation.
The Company previously reported positive safety and encouraging
Phase 1 results with IMNN-001 administered as monotherapy or as
combination therapy in patients with advanced peritoneally
metastasized primary or recurrent ovarian cancer, and completed a
Phase 1b dose-escalation trial (the OVATION 1 Study) of IMNN-001 in
combination with carboplatin and paclitaxel in patients with newly
diagnosed ovarian cancer.
About Epithelial Ovarian
Cancer
Epithelial ovarian cancer (EOC) is the fifth
deadliest malignancy among women in the United States. There are
approximately 22,000 new cases of ovarian cancer every year and
approximately 70% are diagnosed in advanced Stage III/IV. EOC is
characterized by dissemination of tumor in the peritoneal cavity
with a high risk of recurrence (75% in Stage III/IV) after surgery
and chemotherapy. Since the five-year survival rates of patients
with Stage III/IV disease at diagnosis are poor (41% and 20%,
respectively), there remains a need for a therapy that not only
reduces the recurrence rate, but also improves overall survival.
The peritoneal cavity of advanced ovarian cancer patients contains
the primary tumor environment and is an attractive target for a
regional approach to immune modulation.
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 is developing its non-viral DNA
technology across four modalities. The first modality, TheraPlas™,
is developed for the coding of proteins and cytokines in the
treatment of solid tumors where an immunological approach is deemed
promising. The second modality, PlaCCine™, is developed for the
coding of viral antigens that can elicit a strong immunological
response. This technology may represent a promising platform for
the development of vaccines in infectious diseases. The third
modality, FixPlas™, concerns the application of our DNA technology
to produce universal cancer vaccines, also called tumor-associated
antigen cancer vaccines. The fourth modality, which is in the
discovery phase, IndiPlas™, will focus on the development of
personalized cancer vaccines, or neoepitope cancer vaccines.
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 IND-enabling preclinical studies for the development of
a COVID-19 booster vaccine (IMNN-101) and a treatment for the Lassa
virus (IMNN-102). The Company has also initiated preclinical work
to develop a Trp2 tumor-associated antigen cancer vaccine in
melanoma: IMNN-201. We will continue to leverage these modalities
and to advance the technological frontier of plasmid DNA to better
serve patients with difficult-to-treat conditions. For more
information on IMUNON, visit www.imunon.com.
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 |
609-482-2455 |
Kgolodetz@lhai.com |
jchurch@imunon.com |
|
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