Imunon announces data from Phase 2 OVATION 2 study on IMNN-001

IMUNON (IMNN) announced new data from the Company’s Phase 2 OVATION 2 Study of IMNN-001, an investigational therapy for the treatment of advanced ovarian cancer. Results are being highlighted in an oral presentation at the 2025 American Society of Clinical Oncology Annual Meeting, being held May 30 – June 3, 2025, in Chicago, Illinois and virtually, and are also being published simultaneously in the peer-reviewed journal Gynecologic Oncology. Based on the Phase 2 OVATION 2 Study results and following alignment with the U.S. Food and Drug Administration, IMUNON recently initiated the first two sites for its pivotal Phase 3 OVATION 3 Study of IMNN-001 in newly diagnosed advanced ovarian cancer. Participants with newly diagnosed advanced epithelial ovarian cancer in the Phase 2 OVATION 2 Study were randomized 1:1 to evaluate the safety and efficacy of IMNN-001 plus neoadjuvant and adjuvant chemotherapy compared to standard of care N/ACT alone, with a median follow-up of 31 months. Among the findings being presented at the ASCO Annual Meeting: Patients in the intent-to-treat population administered IMNN-001 plus SoC N/ACT achieved a median increase in overall survival of 13 months compared to SoC N/ACT alone, with a hazard ratio of 0.69. Increased therapeutic activity was observed among patients treated with poly ADP-ribose polymerase inhibitors as part of standard maintenance therapy, with the median OS not yet reached in the IMNN-001 treatment arm after more than five years, with a hazard ratio of 0.38. Increased therapeutic activity was also observed in women positive for homologous recombination deficiency including BRCA1 or BRCA2 mutations, with a hazard ratio of 0.42. For the ITT population, patients treated with IMNN-001 plus SoC N/ACT achieved a median 3-month increase in progression-free survival compared to SoC N/ACT alone, with a hazard ratio of 0.79. Patients also receiving PARP inhibitors achieved a median 11.7-month increase in PFS when treated with IMNN-001 and SoC N/ACT compared to SoC N/ACT alone, with a hazard ratio of 0.8. IMNN-001 was well tolerated, with the most common adverse events primarily including abdominal pain, nausea and vomiting. There were no reports of cytokine release syndrome, systemic toxicity or serious immune-related AEs.