IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage company in late-stage
development with its DNA-mediated immunotherapy, announces positive
topline results from the Phase 2 OVATION 2 Study with IMNN-001 in
patients with advanced ovarian cancer. OVATION 2 is a randomized
study of IMNN-001 in combination with neoadjuvant and adjuvant
chemotherapy (NACT) inclusive of interval debulking or
cytoreductive surgery compared with a control arm of
standard-of-care NACT alone. IMNN-001 is the Company’s
interleukin-12 (IL-12) immunotherapy based on its TheraPlas™
technology.
Highlights from patients treated with IMNN-001
plus standard-of-care in a first-line treatment setting
include:
- An 11.1 month increase in median OS
compared with standard-of-care alone in the intent-to-treat
population (ITT).
- A hazard ratio in the ITT
population of 0.74, which indicates a 35% improvement in
survival.
- Among the approximately 90% of
trial participants who received at least 20% of specified
treatments per-protocol in both study arms, patients in the
IMNN-001 arm had a 15.7 month increase in median OS, representing a
further extension of life with a hazard ratio of 0.64, a 56%
improvement in survival.
- For the nearly 40% of trial
participants treated with a poly ADP-ribose polymerase (PARP)
inhibitor, the hazard ratio decreased further to 0.41, with median
OS in the IMNN-001 treatment arm not yet reached at the time of
database lock, compared with median OS of 37.1 months in the
standard-of-care treatment arm.
The PFS results, the trial’s primary endpoint,
support the OS results with:
- A three-month improvement in PFS
compared with standard-of-care alone.
- A hazard ratio in the
intent-to-treat population of 0.79, indicating a 27% improvement in
delaying progression for the IMNN-001 treatment arm.
“These strong and clinically meaningful Phase 2
results are highly encouraging, suggesting that IMNN-001 may
improve the outcomes for women with advanced ovarian cancer. In the
near term, we look forward to advancing our therapeutic into a
Phase 3 pivotal study as soon as possible,” said Stacy Lindborg,
Ph.D., President and Chief Executive Officer of IMUNON.
“Advancements in treatment options for advanced ovarian cancer in
women who require neoadjuvant treatment have been limited over the
years, and these patients continue to have poor prognoses. Our goal
is for IMNN-001 to play an important role in the treatment regimen
for the more than 300,000 women diagnosed with this deadly disease.
On behalf of IMUNON, I extend heartfelt thanks to the women who
participated in this trial, their families and the
investigators.”
OVATION 2 evaluated the dosing, safety, efficacy
and biological activity of intraperitoneal administration of
IMNN-001 in combination with NACT of paclitaxel and carboplatin 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. This open-label study
enrolled 112 patients who were randomized 1:1 and evaluated for
safety and efficacy to compare NACT plus IMNN-001 versus
standard-of-care NACT. In accordance with the study protocol,
patients randomized to the IMNN-001 treatment arm could receive up
to 17 weekly doses of 100 mg/m2 in addition to NACT.
As a Phase 2 study, OVATION 2 was not powered
for statistical significance. Additional endpoints included
objective response rate, chemotherapy response score and surgical
response.
Sebastien Hazard, M.D., Chief Medical Officer of
IMUNON, added, “It is highly gratifying to witness the
extraordinary overall survival benefit that IMNN-001 showed in this
Phase 2 study further supported by consistency across data,
including in progression-free survival and in the patients who
received three doses or more of IMNN-001 gaining an additional 15.7
months of life, while the safety profile was tolerable. It suggests
that IMUNON’s IL-12 gene therapy has a long-term impact on the
disease.”
Commenting on the study results, Premal H.
Thaker, M.D, Interim Chief of Gynecologic Oncology, David &
Lynn Mutch Distinguished Professor of Obstetrics & Gynecology,
Director of Gynecologic Oncology Clinical Research at Washington
University School of Medicine, and the OVATION 2 Study Chair, said,
“Typically an increase in survival of six months is considered to
be clinically meaningful, and extending survival from 29 months
with standard-of-care treatment to 40 months with the addition of
IMNN-001 is compelling. Importantly, the extension of survival
among IMNN-001 patients also exposed to the new standard that
includes PARP inhibitors is even greater. If confirmed in a Phase 3
clinical trial, IMNN-001 could reset the standard of care for women
with ovarian cancer.”
Charles A. “Trey” Leath, III, M.D., Director,
Division of Gynecologic Oncology, Ellen Gregg Shook Culverhouse
Chair in Gynecologic Oncology, Professor, Department of Obstetrics
and Gynecology at University of Alabama Medical Center, and OVATION
2 Principal Investigator, said, “I (We) have been investigating
IMNN-001 since the Phase 1 OVATION 1 Study and continue to be
frustrated by the lack of substantial progress in primary treatment
options available to treat this disease. The results from this
trial demonstrating that IMNN-001 could extend life by one year or
longer are provocative and powerful. I believe that should efficacy
be confirmed in a pivotal study, IMNN-001 will be quickly
incorporated into the care regimen.”
IMUNON plans to hold an End-of-Phase 2 meeting
with the U.S. Food and Drug Administration as soon as possible to
discuss the protocol for a Phase 3 study, which is anticipated to
begin in the first quarter of 2025. IMUNON also plans to present
full OVATION 2 Study results at an upcoming medical conference and
to submit the results for publication in a peer-reviewed medical
journal.
Conference Call and Webcast
IMUNON is hosting a conference call at 8:30 a.m.
Eastern time today to discuss OVATION 2 Study results, next steps
and to answer questions. Dr. Thaker will be joining management on
the call. To participate in the conference call, please dial
833-816-1132 (Toll-Free/North America) or 412-317-0711
(International/Toll) and ask for the IMUNON call. A live webcast of
the call will be available here.
Participants are encouraged to preregister for
the call here.
The call will be archived for replay through
August 13, 2024. The replay can be accessed at 877-344-7529 (U.S.
Toll-Free), 855-669-9658 (Canada Toll-Free) or 412-317-0088
(International Toll), using the replay access code 7783601. A
webcast of the call will be available here for 90 days.
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.
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 sixth deadliest
malignancy among women in the U.S. There are approximately 20,000
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%, 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 IL-12 and interferon
gamma, at the tumor site. Additionally, the Company has entered a
first-in-human study of its COVID-19 booster vaccine (IMNN-101).
IMUNON will continue to leverage these modalities and to advance
the technological frontier of plasmid DNA to better serve patients
with difficult-to-treat conditions, and to further strengthen
IMUNON’s balance sheet through attractive business development
opportunities. 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 timing for commencement of a Phase 3 trial
of IMNN-001, the timing and outcome of the Company’s End-of-Phase 2
meeting with the FDA, the timing and enrollment of the Company’s
clinical trials, the potential of any therapies developed by the
Company to fulfill unmet medical needs, the market potential for
the Company’s products, if approved, the potential efficacy and
safety profile of our product candidates, 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, including the fact that interim
results are not necessarily indicative of final results; 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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