Update Shows Sustained OS Benefit With IMNN-001 in Ovarian Cancer

Final analysis from the phase 2 OVATION 2 trial (NCT03393884) has demonstrated a continued and growing overall survival (OS) advantage with IMNN-001 plus standard-of-care (SOC) neoadjuvant and adjuvant chemotherapy (N/ACT) in women with newly diagnosed advanced ovarian cancer.¹

Updated results reported by IMUNON showed a median 14.7-month improvement in OS in the IMNN-001 treatment arm compared with standard chemotherapy alone (45.1 vs 30.4 months), an increase from the previously reported 11.1-month benefit (40.5 vs 29.4 months). Among the subgroup of patients who also received PARP inhibitor therapy as part of maintenance, the median OS advantage expanded to 24.2 months (65.6 vs 41.4 months).¹

“It is very encouraging to see results from the OVATION 2 trial indicating that treatment with IMNN-001 was associated with an overall survival benefit of more than a year in patients treated with IMNN-001 plus chemotherapy and more than 2 years in women also receiving PARP inhibitors as part of maintenance therapy. These new findings are especially exciting given that there have been no meaningful advances in standard of care in ovarian cancer in the last 30 years,” Premal H. Thaker, MD, chief of Gynecologic Oncology, David & Lynn Mutch Distinguished Professor of Obstetrics & Gynecology, director of Gynecologic Oncology Clinical Research at Washington University School of Medicine, OVATION 2 Study Chair and Study Chair of the phase 3 OVATION 3 trial, stated in a press release.¹

“Importantly, with these new efficacy results, IMNN-001 continues to maintain a highly favorable safety and tolerability profile, further reinforcing the potential of this IL-12 immunotherapy to represent a landmark advance in treatment for women who are in desperate need of new and improved treatment options,” added Thaker.

Background and Study Design

IMNN-001 is an interleukin-12 (IL-12) DNA plasmid vector encapsulated within a polyethyleneglycol-polyethyleneimine (PEG-PEI)-cholesterol lipopolymer nanoparticle delivery system. The randomized, controlled, open-label phase 1/2 OVATION 2 study explored the investigational agent at 19 centers in the United States and Canada.

Overall the OVATION 2 trial enrolled 112 women with newly diagnosed advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer and randomized them 1:1 to receive SOC N/ACTcarboplatin (AUC 6 IV) plus paclitaxel (175 mg/m² IV) every 21 days for 6 cycles, with 3 cycles before and 3 cycles after interval debulking surgery with or without IMNN-001 administered intraperitoneally at 100 mg/m² weekly for up to 17 doses. The primary end point was progression-free survival; secondary end points included OS, objective response rate, chemotherapy response score, and surgical response.²

Efficacy Results

The most recent data assessment represents the final analysis of OVATION 2. The most pronounced effect was observed in the PARP inhibitor subgroup. This finding is consistent with prior assessments in which the PARP inhibitor subgroup demonstrated a numerically larger OS benefit, with earlier data reporting that median OS had not yet been reached in the IMNN-001 arm vs 37.1 months in the SOC arm.³ The safety profile of IMNN-001 remained favorable and was unchanged from prior analyses.

Phase 3 OVATION 3 Trial

Based on the OVATION 2 results and FDA alignment with the trial protocol, IMUNON is currently enrolling patients in the phase 3 OVATION 3 trial (NCT06915025), a pivotal study designed with OS as the primary end point in women with newly diagnosed advanced ovarian cancer.⁴ OVATION 3 is currently enrolling at 7 active clinical sites, with up to 43 additional sites under consideration for activation.

REFERENCES

1. IMUNON, Inc. IMUNON reports updated phase 2 data showing continued improvement in median overall survival with IMNN-001 in women with newly diagnosed advanced ovarian cancer [press release]. Lawrenceville, NJ: IMUNON, Inc.; March 25, 2026.

2. Study of IMNN-001 (also known as GEN-1) with NACT for treatment of ovarian cancer (OVATION 2). ClinicalTrials.gov. NCT03393884. https://clinicaltrials.gov/study/NCT03393884

3. Thaker PH, Richardson DL, Hagemann AR, et al. OVATION-2: a randomized phase I/II study evaluating the safety and efficacy of IMNN-001 (IL-12 gene therapy) with neo/adjuvant chemotherapy in patients newly-diagnosed with advanced epithelial ovarian cancer. Gynecol Oncol. 2025;197:182-191. doi:10.1016/j.ygyno.2025.04.016

4. IMUNON Phase 3 OVATION 3 study. ClinicalTrials.gov. NCT06915025. https://clinicaltrials.gov/study/NCT06915025