IMUNON Reports 11.1-Month Boost in Survival for Advanced Ovarian Cancer Patients Using IMNN-001

IMUNON, Inc., a clinical-stage biotechnology company, has announced promising results from its Phase 2 OVATION 2 Study involving its DNA-mediated immunotherapy, IMNN-001, in patients with advanced ovarian cancer. The OVATION 2 Study is a randomized trial comparing the efficacy of IMNN-001 in combination with neoadjuvant and adjuvant chemotherapy (NACT) against standard NACT treatment alone.

The study highlights several significant findings for patients treated with IMNN-001 alongside standard chemotherapy. In the intent-to-treat (ITT) population, there was an 11.1-month increase in median overall survival (OS) compared to standard treatment alone, with a hazard ratio of 0.74, indicating a 35% improvement in survival. Furthermore, for patients who received at least three doses of IMNN-001 under the 17-dose protocol, the median OS was extended by 15.7 months, translating to a 56% improvement with a hazard ratio of 0.64.

A remarkable outcome was observed among patients who also received maintenance therapy with poly ADP-ribose polymerase (PARP) inhibitors. In this subgroup, the hazard ratio dropped to 0.41, and the median OS had not yet been reached at the time of data lock, suggesting a substantial survival benefit compared to the median OS of 37.1 months in the standard care group.

Besides overall survival, the trial's primary endpoint was progression-free survival (PFS). The results showed a three-month improvement in PFS in the IMNN-001 arm over standard therapy, with a hazard ratio of 0.79, marking a 27% improvement in delaying disease progression.

Stacy Lindborg, Ph.D., IMUNON's President and CEO, emphasized the importance of these findings, stating that the results suggest IMNN-001 could significantly enhance outcomes for women with advanced ovarian cancer. She noted that advancements in treatment for these patients have been limited, and this new therapy could play a crucial role in improving their prognosis.

OVATION 2 enrolled 112 patients newly diagnosed with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer. The study aimed to evaluate the dosing, safety, efficacy, and biological activity of intraperitoneal administration of IMNN-001 combined with NACT, which included paclitaxel and carboplatin. Patients underwent interval debulking surgery after three chemotherapy cycles, followed by additional adjuvant chemotherapy to target any residual tumors.

Sebastien Hazard, M.D., the Chief Medical Officer of IMUNON, expressed satisfaction with the significant overall survival benefit observed in the study. He highlighted the consistent data, including the PFS results and the extended life span for patients who received three or more doses of IMNN-001, as evidence of the therapy's potential long-term impact on the disease.

Dr. Premal H. Thaker, Interim Chief of Gynecologic Oncology at Washington University School of Medicine and OVATION 2 Study Chair, pointed out that an increase in survival of six months is typically considered clinically meaningful. The study's findings, showing a 15.7-month extension in survival with IMNN-001, are highly compelling.

Dr. Charles A. "Trey" Leath, III, Principal Investigator of OVATION 2, expressed optimism about the potential of IMNN-001 to be incorporated into the treatment regimen for ovarian cancer, given the notable extension in survival observed in the trial. He emphasized the need for new primary treatment options for ovarian cancer and the potential of IMNN-001 to address this gap if efficacy is confirmed in a Phase 3 trial.

IMUNON plans to engage with the U.S. Food and Drug Administration (FDA) to discuss the protocol for a Phase 3 study, which is anticipated to commence in the first quarter of 2025. The company intends to present the complete OVATION 2 Study results at an upcoming medical conference and submit the findings for publication in a peer-reviewed journal.