IMNN-001 (intraperitoneal IL-12 plasmid gene therapy) + carbo/taxol nudges PFS/OS upward in newly diagnosed advanced ovarian cancer

IMNN-001 is an intraperitoneal immunotherapy nanoparticle delivering a DNA plasmid encoding IL-12, given weekly alongside neoadjuvant/adjuvant carboplatin/paclitaxel around interval debulking surgery in the open-label OVATION-2 randomized Phase I/II study (control n=54; IMNN-001 arm n=58; predominantly stage IIIC/IV high-grade EOC). Median PFS was 14.9 vs 11.9 months (HR 0.79; 95% CI 0.51–1.23) and median OS was 46.0 vs 33.0 months (HR 0.69; 95% CI 0.40–1.19), with higher R0 resection rates (64.6% vs 52.1%); safety looked chemo-like (GI/cytopenias) with no CRS and no signal for increased immune AEs. As a benchmark, first-line PARP maintenance can deliver much larger PFS gains in biomarker-selected patients—e.g., SOLO-1 BRCA-mut: median PFS 56.0 vs 13.8 months (HR 0.33) and PRIMA all-comers: 13.8 vs 8.2 months (HR 0.62)—so IMNN-001’s current signal reads as incremental and needs confirmation, though the PARPi-maintenance subgroup here also numerically favored IMNN-001 (PFS 33.8 vs 22.1 months; OS NE vs 37.1 months; HR 0.38, CI crosses 1).