IMNN-001 - (OVATION 2)

November 6, 2026: IMUNON, Inc. (NASDAQ: IMNN) reported translational data from the randomized Phase 2 OVATION 2 study of IMNN-001 in newly diagnosed advanced ovarian cancer, presented at SITC 2026. In paired biopsies analyzed with 21 immune markers, adding IMNN-001 to neoadjuvant/adjuvant paclitaxel-carboplatin increased CD8+/Treg, CD8+/CD4+, and CD8+/IDO+ ratios in both tumor and stroma, while chemotherapy contributed proinflammatory macrophage polarization and reduced myeloid infiltration. The company said these findings support a shift of the tumor microenvironment from “cold” to “hot.”

The data are presented as a mechanistic explanation for previously reported OVATION 2 outcomes: final median overall survival improved by 14.7 months (45.1 vs. 30.4 months) and median progression-free survival improved by 3 months versus standard of care alone. OVATION 2 enrolled 112 patients with newly diagnosed Stage III/IV epithelial ovarian cancer.

IMUNON said the findings reinforce the ongoing pivotal Phase 3 OVATION 3 trial (NCT06915025), which is enrolling patients with newly diagnosed Stage IIIB/C or IV epithelial ovarian, fallopian tube, or primary peritoneal cancer. The primary endpoint is overall survival. The poster (No. 478) was scheduled for Poster Session 2 at SITC on November 7, 2026.