New Immunotherapy Extends Survival in Advanced Ovarian Cancer Trial

NEW YORK, NY – December 29, 2025 – In a significant development for women's oncology, clinical-stage biotechnology company Imunon, Inc. has reported promising results for its lead immunotherapy candidate, IMNN-001, which extended overall survival by more than a year in patients with newly diagnosed advanced ovarian cancer. The findings from its Phase 2 trial offer a potential breakthrough in a field that has seen minimal advancement in frontline treatment for over three decades, bringing a new sense of hope to patients and clinicians battling one of the deadliest gynecologic cancers.

Data from the company's OVATION 2 study, published in the peer-reviewed journal Gynecologic Oncology and presented at the American Society of Clinical Oncology (ASCO) annual meeting, showed that adding IMNN-001 to the standard chemotherapy regimen increased median overall survival to 46 months, compared to 33 months for patients receiving chemotherapy alone. This 13-month survival benefit, represented by a hazard ratio of 0.70, signals a potentially transformative impact on the standard of care.

Confronting a Decades-Old Challenge

Advanced ovarian cancer carries a grim prognosis. Often diagnosed in later stages due to its vague and subtle symptoms, the disease has a five-year survival rate of just 27%. For more than 30 years, the primary treatment has remained largely unchanged: aggressive debulking surgery followed by platinum-based chemotherapy. While effective initially, the cancer frequently recurs, often developing resistance to platinum-based drugs and leaving patients with few effective options.

The critical unmet need is for new frontline therapies that can improve long-term outcomes and delay recurrence. The integration of PARP inhibitors and anti-angiogenic agents like bevacizumab as maintenance therapies has provided some benefit, but these are typically for specific patient subgroups. IMNN-001 is being positioned as a broad treatment to be administered alongside initial chemotherapy, aiming to fundamentally improve the body's initial response to the cancer.

The Science of a Targeted Immune Strike

At the heart of IMNN-001's success is Imunon's proprietary TheraPlas platform, a novel technology designed to solve a long-standing problem in immunotherapy. The treatment uses a DNA plasmid to deliver the genetic code for Interleukin-12 (IL-12), a powerful cytokine known for its ability to activate a robust anti-cancer immune response by mobilizing T-lymphocytes and natural killer (NK) cells.

Previous attempts to use IL-12 as a cancer therapy were thwarted by severe systemic toxicity when the protein was administered throughout the body. The TheraPlas platform bypasses this critical issue. By encasing the IL-12 DNA in a nanoparticle, IMNN-001 is administered directly into the peritoneal cavity—the area where ovarian cancer resides and metastasizes. This allows for localized transfection of cells, which then produce and secrete IL-12 directly within the tumor microenvironment.

This targeted approach effectively turns immunologically 'cold' tumors 'hot,' remodeling the local environment to favor an anti-tumor attack without causing the dangerous systemic side effects like cytokine release syndrome. The OVATION 2 trial confirmed this favorable safety profile, reporting no serious immune-related adverse events, a key differentiator from many other immunotherapies. The most common side effects were manageable and included abdominal pain and nausea, consistent with intraperitoneal administration.

A Promising Path to Market

Building on the strength of the Phase 2 data, Imunon is actively enrolling patients in its pivotal Phase 3 OVATION 3 study. The trial is designed in alignment with the U.S. Food and Drug Administration (FDA) and includes two planned interim analyses. These analyses create a strategic opportunity for an accelerated timeline to file a Biologics License Application (BLA), particularly if the primary endpoint of overall survival shows strong statistical significance early in a key patient subgroup.

That subgroup consists of patients whose tumors are positive for homologous recombination deficiency (HRD+), a genetic signature that includes BRCA mutations. In the OVATION 2 study, this HRD+ population showed an even stronger response to IMNN-001, with a hazard ratio of 0.42, suggesting a profound benefit. For patients in the trial who later received PARP inhibitors as maintenance therapy, the median overall survival in the IMNN-001 arm had not even been reached after five years of follow-up, compared to just 37 months in the control arm.

IMNN-001 has already received both Fast Track and Orphan Drug designations from the FDA. These designations are intended to expedite the development and review of drugs that address serious conditions and unmet medical needs. They provide benefits such as more frequent FDA communication, a potential for rolling review of the BLA, and seven years of market exclusivity upon approval, creating a clearer regulatory and commercial path for Imunon.

Despite the positive clinical news, the company's financial position reflects the high-risk, high-reward nature of clinical-stage biotechnology. With a market capitalization hovering near its 52-week lows, Imunon's stock (NASDAQ: IMNN) has been volatile. However, some analysts maintain a 'Buy' rating, seeing significant upside potential if the OVATION 3 study validates the earlier findings. The company has stated it is focused on financial discipline as it advances its pivotal trial, which will be the ultimate arbiter of IMNN-001's future and the company's future. As enrollment continues, the oncology community watches with cautious optimism, hopeful that a new standard of care for ovarian cancer is finally within reach.