IMUNON Announces First Patient enrolled in Phase 1/2 Clinical Trial of IMNN-001 in Combination with bevacizumab in Advanced Ovarian Cancer
2023年10月18日 - 9:30PM
IMUNON, Inc. (NASDAQ:
IMNN), a clinical-stage drug-development company focused
on developing non-viral DNA-mediated immunotherapy and
next-generation vaccines, announces that the first patient in a
Phase 1/2 clinical trial evaluating IMUNON’s IMNN-001 in
combination with bevacizumab in advanced ovarian cancer has begun
treatment. IMNN-001 is a DNA-based interleukin-12 (IL-12)
immunotherapy currently in Phase 2 clinical development for the
localized treatment of advanced ovarian cancer (the OVATION 2
Study).
This Phase 1/2 trial is expected to enroll 50
patients with Stage III/IV advanced ovarian cancer. Patients
undergoing frontline neoadjuvant therapy will be randomized 1:1 to
receive standard chemotherapy plus bevacizumab vs. chemotherapy
plus bevacizumab and IMNN-001. The trial’s primary endpoint is
detection of minimal residual disease (MRD) by second look
laparoscopy (SLL) and the secondary endpoint is progression-free
survival (PFS). Initial SLL data are expected within one year
following the completion of enrollment and final PFS data are
expected approximately three years following the completion of
enrollment. This trial will also include a wealth of translational
endpoints aimed at understanding the clonal evolution and
immunogenomic features of the MRD phase of ovarian cancer that is
currently undetectable by imaging or tumor markers.
The principal investigator of this clinical
trial is Amir Jazaeri, M.D., Professor of Gynecologic Oncology and
Reproductive Medicine at The University of Texas MD Anderson Cancer
Center. The Koch Institute for Integrative Cancer Research at the
Massachusetts Institute of Technology will also be involved in
translational analyses using trial samples and animal models of
ovarian cancer MRD, including biomarker and genomic analyses, which
is expected to expand the Company’s knowledge of the treatment
paradigm. These initiatives are a part of the Break Through Cancer
Targeting Ovarian Cancer Minimal Residual Disease (MRD) Using
Immune and DNA Repair Directed Therapies TeamLab collaboration.
Dr. Corinne Le Goff, President and Chief
Executive Officer of IMUNON, said, “This new trial testing the
combination of IMNN-001 and bevacizumab in ovarian cancer starts as
we have just announced very encouraging interim data for our
OVATION 2 program evaluating the benefits of IMNN-001 in the
neoadjuvant setting. We believe the combination of IMNN-001 and
bevacizumab holds promise based on findings in our earlier
pre-clinical animal studies, where the combination showed strong
synergies. IMNN-001 as an innovative immunotherapy may transform
the current ovarian cancer first line treatment landscape and
provide new options to women diagnosed with Stage III/IV disease
who face low cure rates of 15% or less.”
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
the majority (approximately 70%) are diagnosed in advanced Stages
III and IV. EOC is characterized by dissemination of tumor in the
peritoneal cavity with a high risk of recurrence (75%, Stages III
and IV) after surgery and chemotherapy. Since the five-year
survival rates of patients with Stages III and 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 IMNN-001
Immunotherapy
Designed using IMUNON’s proprietary
TheraPlas® platform technology, IMNN-001 (formerly GEN-1) 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. It announced full enrollment
in the OVATION 2 Study in September 2022, interim data in September
2023 and expects to report topline data in the second quarter of
2024.
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, IndiPlas®, is in the
discovery phase and 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.
About Break Through Cancer
Launched in February 2021, Break Through Cancer
is a public foundation designed to find new solutions to the most
intractable challenges in cancer. The foundation was launched with
an extraordinary challenge pledge of $250 million from Mr. and Mrs.
William H. Goodwin, Jr. and their family, and the estate of William
Hunter Goodwin III. This represents one of the largest gifts ever
in support of cancer research. Led by Dr. Tyler Jacks, the David H.
Koch Professor of Biology and Director of the Koch Institute for
Integrative Cancer Research at MIT, Break Through Cancer funds and
supports collaborative research teams drawn from several of the
country’s top cancer centers.
Multidisciplinary research teams are selected
from across five participating institutions: Dana-Farber Cancer
Institute, the Sidney Kimmel Comprehensive Cancer Center at Johns
Hopkins, The University of Texas MD Anderson Cancer Center,
Memorial Sloan Kettering Cancer Center, and MIT’s Koch Institute
for Integrative Cancer Research.
Break Through Cancer is focused on historically
highly challenging cancer types, including pancreatic cancer,
ovarian cancer, glioblastoma and acute myelogenous leukemia for its
initial programs, aided by the guidance of a scientific advisory
board of cancer experts from outside the participating
institutions. Teams will receive substantial funding to bring new
approaches and new thinking as rapidly as possible to the clinical
challenges of cancer.
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 |
and Corporate Secretary |
Kgolodetz@lhai.com |
609-482-2455 |
|
jchurch@imunon.com |
|
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