IMUNON, Inc. announced database lock for its Phase 2 OVATION 2 Study evaluating the safety and efficacy of IMNN-001 in patients with advanced ovarian cancer. Median Overall Survival (OS) and Progression Free Survival (PFS) have been reached and all patients in the open-label study have achieved treatment observation duration of 16 months, as required per protocol to evaluate efficacy. The independent statisticians have received the raw trial data and will follow the statistical analysis plan as they analyze the data from the trial.

IMUNON expects to report topline results including hazard ratios before the end of July 2024. OVATION 2 is evaluating the dosing, safety, efficacy and biological activity of intraperitoneal administration of IMNN-001 in combination with neoadjuvant chemotherapy (NACT) in patients newly diagnosed with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer. Since the five-year survival rates of patients with Stage III/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.