IMUNON, Inc. announced positive topline results from the Phase 2 OVATION 2 Study with IMNN-001 in patients with advanced ovarian cancer. OVATION 2 is a randomized study of IMNN-001 in combination with neoadjuvant and adjuvant chemotherapy (NACT) inclusive of interval debulking or cytoreductive surgery compared with a control arm of standard-of-care NACT alone. IMNN-001 is the Company?s interleukin-12 (IL-12) immunotherapy based on its TheraPlas technology.

Highlights from patients treated with IMNN-001 plus standard-of-care in a first-line treatment setting include: An 11.1 month increase in median OS compared with standard-of-care alone in the intent-to-treat population (ITT). A hazard ratio in the ITT population of 0.74, which indicates a 35% improvement in survival. Among the approximately 90% of trial participants who received at least 20% of specified treatments per-protocol in both study arms, patients in the IMNN-001 arm had a 15.7 month increase in median OS, representing a further extension of life with a hazard ratio of 0.64, a 56% improvement in survival.

For the nearly 40% of trial participants treated with a poly ADP-ribose polymerase (PARP) inhibitor, the hazard ratio decreased further to 0.41, with median OS in the IMNN-001 treatment arm not yet reached at the time of database lock, compared with median OS of 37.1 months in the standard-of-care treatment arm. The PFS results, the trial?s primary endpoint, support the OS results with: A three-month improvement in PFS compared with standard-of-care alone. A hazard ratio in the intent-to-treat population of 0.79, indicating a 27% improvement in delaying progression for the IMNN-001 treatment arm.

OVATION 2 evaluated the dosing, safety, efficacy and biological activity of intraperitoneal administration of IMNN-001 in combination with NACT of paclitaxel and carboplatin in patients newly diagnosed with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer. Treatment in the neoadjuvant period is designed to shrink the tumors as much as possible for optimal surgical removal after three cycles of chemotherapy. Following NACT, patients undergo interval debulking surgery, followed by three additional cycles of adjuvant chemotherapy to treat any residual tumor.

This open-label study enrolled 112 patients who were randomized 1:1 and evaluated for safety and efficacy to compare NACT plus IMNN-001 versus standard-of-care NACT. In accordance with the study protocol, patients randomized to the IMNN-001 treatment arm could receive up to 17 weekly doses of 100 mg/m2 in addition to NACT. As a Phase 2 study, OVATION 2 was not powered for statistical significance.

Additional endpoints included objective response rate, chemotherapy response score and surgical response. IMUNON plans to hold an End-of-Phase 2 meeting with the U.S. Food and Drug Administration as soon as possible to discuss the protocol for a Phase 3 study, which is anticipated to begin in the first quarter of 2025. IMUNON also plans to present full OVATION 2 Study results at an upcoming medical conference and to submit the results for publication in a peer-reviewed medical journal.