Clinical TrialJul 30, 2026, 09:06 AM
Imunon OVATION 3 Trial Enrollment Exceeding Forecasts
AI Summary
Imunon, Inc. announced that enrollment for its pivotal Phase 3 OVATION 3 trial of IMNN-001 for advanced ovarian cancer is exceeding forecasts. The company observed rapid site activation and an enrollment rate of approximately 0.5 patients per site per month, significantly higher than the assumed 0.3 patients per site per month. This strong momentum, supported by promising Phase 2 data and a favorable safety profile, leads to a projected enrollment completion in the second quarter of 2029, with two pre-planned interim analyses anticipated.
Key Highlights
- OVATION 3 trial enrollment rate is approximately 0.5 patients per site per month.
- This exceeds the assumed rate of 0.3 patients per site per month.
- The assumed rate of 0.3 was already a premium to the industry average of 0.2.
- Trial advanced from protocol submission to site activation in approximately 6 months.
- First patient randomized in approximately 2 months from protocol approval, one-third of industry benchmark.
- Over 70% of sites are meeting or exceeding the assumed average enrollment rate.
- Enrollment is now projected to be completed in the second quarter of 2029.
- Two pre-planned interim analyses are expected for potential early BLA filing.
Price Impact
More from IMNN