IMUNON Announces Database Lock for Phase 2 OVATION 2 Study with IMNN-001 in Advanced Ovarian Cancer
June 24 2024 - 8:30AM
IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage company in advanced
development of its non-viral DNA-mediated immunotherapy, announces
database lock for its Phase 2 OVATION 2 Study evaluating the safety
and efficacy of IMNN-001 in patients with advanced ovarian cancer.
Median Overall Survival (OS) and Progression Free Survival (PFS)
have been reached and all patients in the open-label study have
achieved treatment observation duration of 16 months, as required
per protocol to evaluate efficacy. The independent statisticians
have received the raw trial data and will follow the statistical
analysis plan as they analyze the data from the trial. IMUNON
expects to report topline results including hazard ratios before
the end of July 2024.
OVATION 2 is evaluating the dosing, safety,
efficacy and biological activity of intraperitoneal administration
of IMNN-001 in combination with neoadjuvant chemotherapy (NACT) in
patients newly diagnosed with advanced epithelial ovarian,
fallopian tube or primary peritoneal cancer. Treatment in the
neoadjuvant period 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 adjuvant
chemotherapy to treat any residual tumor. Patients were randomized
1:1 and evaluated for safety and efficacy to compare NACT plus
IMNN-001 versus standard-of-care NACT. Patients randomized to the
IMNN-001 treatment arm received up to 17 doses of 100 mg/m2, in
addition to NACT. Full enrollment of 110 patients was reached in
September 2022.
The OVATION 2 Study is meant to inform the
design of the intended Phase 3 trial and was not powered for
statistical significance. Per the Statistical Analysis Plan (SAP),
the primary efficacy analysis will be based on the Intent to Treat
(ITT) population. The primary efficacy endpoint is PFS, with
secondary endpoints including OS, Objective Response Rate,
Chemotherapy Response Score and Surgical Response.
Stacy Lindborg, Ph.D., president and chief
executive officer of IMUNON, said, “Reaching data lock for the
OVATION 2 Study is a significant achievement for our team and a
step forward in our mission to bring an innovative treatment to
patients battling ovarian cancer. With the last patient enrolled in
September 2022, the analyses generated using the ITT population, an
industry gold standard, will now have sufficient data maturity to
analyze both PFS and OS endpoints with a good level of confidence.
We are hopeful that IMNN-001 will offer improved outcomes and a
much-needed alternative to those affected by this deadly
disease.”
Sebastien Hazard, M.D., Ph.D., chief medical
officer of IMUNON, added, “Given the maturity of our data, OS will
be important in the readout of the trial and in planning the Phase
3 trial. As the definitive endpoint, OS has been observed across
all tumor types as most reflective of the long-term benefit of
immunotherapies. We look forward to the trial readout and sharing
learnings from the trial with the patient and medical
community.”
About IMNN-001
Immunotherapy
Designed using IMUNON's proprietary TheraPlas®
platform technology, IMNN-001 is an interleukin-12 (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.
IMUNON 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 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.
Epithelial ovarian cancer 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 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
its modalities. The first modality, TheraPlas®, is developed for
the coding of cytokines and other therapeutic proteins in the
treatment of solid tumors where an immunological approach is deemed
promising. The second modality, PlaCCine®, is developed for the
delivery of DNA-coded viral antigens that can elicit a strong
immunological response.
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. IMUNON will continue to
leverage this novel technology and to advance the therapeutic
potential of plasmid DNA to better serve patients with
difficult-to-treat conditions. For more information, please
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. All statements, other than
statements of historical fact, including, but not limited to,
statements regarding the Company’s IND application, expectations
regarding the Phase 1 clinical study of IMNN-101, including with
respect to enrollment for the study and reporting of data, the
potential efficacy and safety profile of our PlaCCine platform,
potential partnering opportunities, and the Company’s plans and
expectations with respect to its development programs more
generally, are forward-looking statements. We generally identify
forward-looking statements by using words such as “may,” “will,”
“expect,” “plan,” “anticipate,” “estimate,” “intend” and similar
expressions (as well as other words or expressions referencing
future events, conditions or circumstances). Readers are cautioned
that such forward-looking statements involve risks and
uncertainties including, without limitation, uncertainties relating
to 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 actions by customers, suppliers, competitors or regulatory
authorities; and other risks detailed from time to time in IMUNON’s
filings with the Securities and Exchange Commission. IMUNON assumes
no obligation, except to the extent required by law, to update or
supplement forward-looking statements that become untrue because of
subsequent events, new information or otherwise.
Contacts:
IMUNON |
LHA Investor Relations |
David Gaiero |
Kim Sutton Golodetz |
978-376-6352 |
212-838-3777 |
dgaiero@imunon.com |
kgolodetz@lhai.com |
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