Full Press Release Details
Reports 2024 Financial Results and Provides Business Update Highlighting Significant Progress Towards the Initiation of a Pivotal Phase
remains the first immunotherapy to achieve a meaningful overall survival benefit in advanced ovarian cancer
enrollment in Phase 3 pivotal trial of IMNN-001 scheduled to begin in Q1 2025
to hold conference call today at 11:00 a.m. ET
N.J., Feb. 27, 2025 (GLOBE NEWSWIRE) - IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage
company in late-stage development with its DNA-mediated immunotherapy, today reported financial results for the year ended December 31,
2024 and highlighted recent business updates including progress in advancing the IMNN-001 development program toward initiation of a
Phase 3 clinical trial in advanced ovarian cancer.
was a pivotal year for IMUNON. We reported robust and unprecedented data from our Phase 2 OVATION 2 Study, demonstrating that IMNN-001
is the first immunotherapy to consistently show clinical benefits in both progression-free and overall survival in ovarian cancer when
combined with chemotherapy," said Stacy Lindborg, Ph.D., president and chief executive officer of IMUNON. "Treated patients
achieved an overall survival of 13 months, compared to the current standard of care. Even more remarkable, the survival extension was
greater among patients treated with IMNN-001 plus PARP inhibitors."
stand at the threshold of a historic advance in the frontline treatment of women with advanced ovarian cancer, a group with limited options
and a desperate need for safe, effective treatments," Dr. Lindborg continued. "The most recent advances in ovarian cancer treatment
have focused on maintenance treatment for those who have already responded to chemotherapy. However, our results in newly diagnosed patients
with advanced disease are unprecedented and highly encouraging. The rapid clinical progress we have made reflects our compelling data
and the strong support from trial investigators, patients, regulators, and global scientific leaders. We have engaged with the U.S. Food
and Drug Administration through an End-of-Phase 2 meeting to finalize the design of our planned registrational study. As we look forward
to an exciting year ahead, we are preparing to initiate a Phase 3 pivotal study of IMNN-001 in the first quarter of 2025."
Data from OVATION 2 Study reinforce dose-dependent mechanism with IMNN-001 100mg/m2 dose and continue to validate TheraPlas
technology, demonstrating DNA-mediated production of key anti-cancer immune cytokines following treatment - On February 19,
2025, IMUNON announced new translational data from ongoing analyses of results from the Company's Phase 2 OVATION 2 Study of IMNN-001
for the treatment of newly diagnosed advanced ovarian cancer. Results demonstrated a 20% increase in IL-12 levels in women treated with
IMNN-001 (100 mg/m2 administered intraperitoneally weekly) plus standard-of-care (SoC) neoadjuvant and adjuvant chemotherapy
(NACT) compared to IL-12 levels in women treated with IMNN-001 (79 mg/m2). In this analysis increases in IL-12 levels were
sampled in the peritoneal fluid cavity, which is the primary tumor microenvironment. Little to no changes were observed in the systemic
blood stream of treated patients. In addition, the rise in IL-12 levels was accompanied by local increases in interferon-gamma (IFN- )
and tumor necrosis factor-alpha (TNF- ), key downstream anti-cancer immune cytokines. Results showed no reports of serious immune-related
adverse events including cytokine release syndrome.
CMC Meeting with FDA for IMNN-001 - On December 19, 2024, IMUNON announced the positive outcome of a Type C Chemistry, Manufacturing,
and Controls (CMC) meeting with the U.S. Food and Drug Administration (FDA) regarding production of IMNN-001 for the treatment of women
with newly diagnosed advanced ovarian cancer. The goal of the meeting was to seek alignment and agreement with the FDA on key CMC topics
to support IMNN-001 production for the planned Phase 3 pivotal trial and a potential future new biologics license application (BLA) submission.
The meeting with the FDA included a review of IMUNON's current good manufacturing practice (cGMP) clinical-scale and commercial
manufacturing processes for IMNN-001, conducted at the Company's manufacturing facility based in Huntsville, Alabama. The FDA agreed
that IMUNON's potency assay, which measures interferon-gamma (IFN- ), is acceptable for the Phase 3 trial and for use in
a commercial setting for release of drug product. The agency also agreed with the Company's strategy to establish comparability
of the core components of IMNN-001 produced by IMUNON with product previously produced through an external contract development and manufacturing
Improvement in Overall Survival Data from OVATION 2 Study of IMNN-001 - On December 10, 2024, the Company announced additional
clinical data based on ongoing analyses of results from the Phase 2 OVATION 2 Study of IMNN-001 in the treatment of advanced ovarian
cancer. The updated results, which were based on an additional seven months of patient monitoring, showed the hazard ratio (HR) decreased
from 0.74 to 0.69, with an increase in median overall survival (OS) from 11.1 to 13 months following treatment with IMNN-001 plus standard-of-care
(SoC) neoadjuvant and adjuvant chemotherapy (NACT) versus SoC alone. More than one-third of patients in the trial survived more than
36 months from the point of study enrollment, with 62% of those surviving patients from the IMNN-001 treatment arm and 38% from the SoC
arm. More than 10% of trial participants reached 48 months or beyond at the time of this data assessment. Results also continued to demonstrate
a favorable safety and tolerability profile, with no reports of cytokine release syndrome or any other serious immune-related adverse
events. Initial results from the OVATION 2 Study were reported in July 2024 and results were presented in a late-breaking session at
the Society for Immunotherapy of Cancer (SITC) 39th Annual Meeting.
2 Meeting with the FDA for IMNN-001 Clinical Program - On November 25, 2024, IMUNON announced a positive outcome of its End-of-Phase
2 in-person meeting with the FDA, supporting the advancement of IMNN-001 for the treatment of advanced ovarian cancer into a Phase 3
pivotal study. IMUNON remains on track to initiate the Phase 3 trial in the first quarter of 2025. The interaction with the FDA included
an extensive review of data generated to date, including the positive results from the Phase 2 OVATION 2 Study.
Ovarian Cancer R&D Day - On September 18, 2024, the Company held an Ovarian Cancer R&D Day in New York City that included
presentations from executive management and a panel of renowned leaders in oncology research and patient care including:
webcast of the Ovarian Cancer R&D Day is available here.
Next Generation Vaccine Proof of Concept
from PlaCCine DNA Vaccine Phase 1 Proof-of-Concept Clinical Study Demonstrate Persistent Immunogenicity in Trial Participants, Show an
Acceptable Safety Profile and Further Validate PlaCCine Technology - On February 26, 2025, the Company announced
safety and immunogenicity data from the Company's first Phase 1 proof-of-concept clinical trial of IMNN-101, its investigational
DNA plasmid vaccine based on the Company's proprietary PlaCCine technology platform. The Phase 1 study was conducted
in 24 healthy volunteers as a seasonal COVID-19 vaccine, targeting the SARS-CoV-2 Omicron XBB1.5 spike antigen. IMNN-101 was administered
as a single dose vaccine without a booster dose in study participants who were previously vaccinated against the Omicron XBB1.5 variant.
Results demonstrated that IMNN-101 is safe and well-tolerated with no serious adverse effects. IMNN-101 induced a persistent 2- to 4-fold
increase in serum neutralizing antibody (NAb) titers from baseline through Week 4, further increasing NAb titers between Week 2 and Week
4. The immune response was observed against the XBB1.5 variant and many newer variants following treatment, demonstrating the IMNN-101
vaccine's cross-reactivity. The participants in the Phase 1 trial had high baseline immune characteristics presumably from prior
infection and multiple previous vaccinations against COVID-19 and ongoing infection as evidenced by the rise in viral nucleocapsid antigen
during the study period. Modest increases in T cell responses were observed in this setting of trial participants having received
multiple immunizations prior to the study.
Phase 1 clinical data of IMNN-101 is consistent with strong evidence of immunogenicity and protection for the PlaCCine platform in rodents
and non-human primates, with prior preclinical results showing that protection exceeded 95% in non-human primates, which is comparable
to mRNA vaccines. The robust immunogenicity profile, expected durability of protection, comparative ease of manufacturing, and stability
at workable temperatures (up to one year at 4 C and one month at 37 C) suggest that a vaccine based on the PlaCCine technology
platform may be a potential viable alternative to available messenger RNA (mRNA) vaccines. The Company plans to seek potential partners
for further development.
to Leadership Team to Support Future Clinical Programs - On February 10, 2025, Douglas V. Faller, M.D., Ph.D. was appointed
Chief Medical Officer effective February 18, 2025. Dr. Faller joins IMUNON with more than 30 years of industry, academic and laboratory
experience, with specialized expertise in oncology and immunology. Dr. Faller will lead the Company's clinical strategy including
advancing the IMNN-001 program for the treatment of newly diagnosed advanced ovarian cancer.
Faller joins IMUNON with more than 30 years of experience at biotechnology and pharmaceutical companies leading strategies across discovery,
preclinical, clinical and regulatory stages of small molecule development in several therapeutic areas including oncology, immunology
and hematology. He also brings more than 25 years of experience in academic clinical and laboratory research settings with a focus on
drug discovery and development, oncology and hematology, and cell and molecular biology. Dr. Faller most recently served as chief medical
officer at Skyhawk Therapeutics, where he was responsible for global clinical and regulatory development of novel small molecule RNA-splicing
modifiers for the treatment of hematological and solid tumors and rare neurological diseases. Before that, he served as chief medical
officer at Oryzon Genomics, Inc. Previously, he worked at Takeda for more than five years in roles of increasing responsibility, most
recently serving as executive medical director where he led the development of multiple late-stage therapies including a CAR-T program
for leukemias and lymphomas and solid tumor programs including in gynecologic oncology.
Faller received an M.D. from Harvard Medical School and a Ph.D. and B.S. from the Massachusetts Institute of Technology. He was professor
of medicine at Harvard Medical School, and subsequently he founded and served as first director of Boston University Comprehensive Cancer
Center where he was also Grunebaum Professor for Cancer Research and professor of medicine, biochemistry, pediatrics, microbiology, pathology
and laboratory medicine. Dr. Faller is the scientific founder of multiple biotechnology and pharmaceutical companies.
Results for the Year Ended December 31, 2024
reported a net loss for 2024 of $18.6 million, or $1.62 per share compared with a net loss for 2023 of $19.5 million, or $2.16 per share.
Operating expenses were $19.1 million for 2024, a decrease of $1.9 million or 9% from $21.0 million for 2023. The Company recognized
tax benefits from the sale of its New Jersey net operating losses of $1.3 million in 2023.
and development (R&D) expenses were $11.6 million for 2024, a decrease of $0.3 million from $11.3 million for 2023. Costs associated
with the OVATION 2 Study were $1.4 million and $1.2 million for 2024 and 2023, respectively. Costs associated with our PlaCCine
vaccine initiative were $1.4 million in 2024. Other clinical and regulatory costs, which include start up costs for OVATION 3,