Novel Immunotherapy IMNN-001 Shows Extended Survival Rates for Ovarian Cancer

The novel immunotherapy IMNN-001 shows promising results for advanced ovarian cancer treatment in the Phase 2 OVATION 2 Study. When combined with standard chemotherapy, IMNN-001 extended the median overall survival by 11.1 months.

IMUNON has announced significant results from its Phase 2 OVATION 2 Study, evaluating IMNN-001, a pioneering immunotherapy, in newly diagnosed advanced ovarian cancer patients. The study demonstrated an 11.1-month increase in median overall survival (OS) when IMNN-001 was combined with standard chemotherapy. Further enhanced survival rates were observed with combined PARP inhibitor therapy, with some groups experiencing a median OS that has not yet been reached.

Dr. Stacy Lindborg, CEO of IMUNON, expressed optimism about the therapy’s future, stating, "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.”

The randomized study investigated IMNN-001, which utilizes IMUNON's TheraPlas™ technology to deliver interleukin-12 (IL-12), a powerful cytokine that boosts immune system responses against cancer. The therapy was tested alongside neoadjuvant and adjuvant chemotherapy, treatments aimed at shrinking tumors before and after surgery.

In the trial involving 112 patients, those treated with IMNN-001 experienced a median overall survival extension of nearly a year compared to the control group receiving only standard chemotherapy. This benefit was even more pronounced in patients who received the complete protocol of up to 17 doses of IMNN-001, where survival extended by an additional 15.7 months.

Commenting on the significance of the findings, Dr. Premal H. Thaker, Interim Chief of Gynecologic Oncology at Washington University School of Medicine, noted, “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.”

The study also showed that patients receiving maintenance therapy with PARP inhibitors, a newer class of drugs, saw even greater benefits. The hazard ratio—a measure of the death rate in the treatment group versus the control group—was just 0.41 for these patients, indicating a substantial survival advantage, with the median overall survival not yet reached at the study's data lock.

Dr. Charles A. “Trey” Leath, III, Principal Investigator of the study, highlighted the impact of these results on the future treatment landscape: “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 discuss the protocol for a Phase 3 study with the U.S. Food and Drug Administration soon and anticipates beginning the pivotal trial in early 2025. Full results of the OVATION 2 Study will be presented at an upcoming medical conference and submitted for publication in a peer-reviewed medical journal.