IMNN-001 - (OVATION 2)

Sept. 24, 2026: IMUNON (NASDAQ: IMNN) presented an R&D Day update on IMNN-001 for newly diagnosed advanced ovarian cancer, highlighting final Phase 2 OVATION 2 overall survival data, preliminary Phase 2 MRD findings, and progress in the pivotal Phase 3 OVATION 3 trial.

In OVATION 2 (112 patients), IMNN-001 plus neoadjuvant/adjuvant chemotherapy showed median overall survival of 45.1 months vs 30.4 months for standard of care alone, a 14.7-month difference; the company said this widened from 11.1 months at the July 2024 readout to the December 2025 final analysis. In the PARP inhibitor maintenance subgroup, median overall survival was 65.6 vs 41.4 months. The release says primary/secondary endpoints and safety favored IMNN-001, with no cytokine release syndrome or serious systemic immune-related adverse events historically associated with systemic IL-12.

Preliminary MRD study data were described as too early for efficacy conclusions, but among patients reaching second-look laparoscopy, MRD-positive rate was 44.4% (4/9) vs 66.7% (6/9), ctDNA clearance 87.5% (7/8) vs 62.5% (5/8), and no evidence of disease 100% (9/9) vs 56% (5/9), experimental vs control.

OVATION 3 is a ~500-patient randomized Phase 3 trial with overall survival as the primary endpoint. Two pre-planned event-driven interim analyses are intended to support a potential earlier BLA submission; enrollment completion is targeted for Q1 2029. Independent monitoring committees recommended continuation without modification for OVATION 3 (mid-2026) and the MRD study (August 2026).