IMUNON Announces Its Phase 3 OVATION 3 Trial Of IMNN-001 In Patients With Ovarian Cancer Has Observed Rapid Site Activation And Above-Forecast Enrollment Rate

The trial advanced from protocol submission to site activation in approximately 6 months and from protocol approval to first patient randomized in approximately 2 months, a third of the time of the external industry benchmark.

The currently observed study-level enrollment rate of approximately 0.5 patients per site per month meaningfully exceeds the assumed rate of 0.3 patients per site per month used in the trial plan. That planning assumption was already set at a premium relative to the Company’s OVATION 2 experience and to historical industry ovarian cancer trials, which have generally enrolled at approximately 0.2 patients per site per month. The strong OVATION 3 enrollment is supported by highly promising clinical and biomarker data, most notably the overall survival (OS) evidence from the large, randomized Phase 2 OVATION 2 study and a high rate of conversion from pre-screening to randomization underscores strong interest in the trial by investigators and patients. More than 70% of sites are currently meeting or exceeding the assumed average enrollment rate of 0.3 patients per month. The Company now projects enrollment to be completed in the second quarter of 2029. Two pre-planned interim analyses are expected with the goal of early BLA filing for full regulatory approval if they achieve the pre-specified threshold.