Imunon presents data from Phase 2 OVATION 2 clinical trial

IMUNON (IMNN) announced the presentation of new clinical data from the recently completed Phase 2 OVATION 2 Study of IMNN-001, its investigational interleukin-12 immunotherapy for the treatment of advanced ovarian cancer based on the company’s proprietary TheraPlas technology. Results will be highlighted in a late-breaking poster session at the Society for Immunotherapy of Cancer 39th Annual Meeting, taking place November 6-10, 2024, in Houston, Texas and virtually. IMNN-001 is an IL-12 DNA plasmid vector encased in a nanoparticle delivery system that enables cell transfection followed by persistent, local production and secretion of the IL-12 protein. IL-12 is one of the most active pluripotent cytokines for the induction of strong anti-cancer immunity acting through the induction of T-lymphocyte and natural killer cell proliferation, inhibiting tumor mediated immune suppression. A total of 112 patients with newly diagnosed advanced ovarian cancerwere enrolled in the Phase 2 OVATION 2 Study with a median follow-up of 24 months. Study participants were randomized 1:1 to evaluate the safety and efficacy of IMNN-001 plus neoadjuvant and adjuvant chemotherapy of paclitaxel and carboplatin compared to standard-of-care NACT alone. The results being presented at the SITC Annual Meeting, as of June 21, 2024, demonstrated: Patients treated with IMNN-001 plus standard-of-care NACT lived 11.1 months longer than patients treated with NACT alone with a median overall survival of 40.5 months and 29.4 months, respectively. IMNN-001 treatment was associated with better surgical outcomes compared to NACT alone with a surgical response rate of 64.6% and 52.1%, respectively. The chemotherapy response score, another measure of treatment benefit, was 26.1% in the IMNN-001 treatment group versus 13.0% in the control group. IMNN-001 was also associated with an improvement in progression-free survival with a median PFS of 14.9 months in the IMNN-001 treatment group compared to 11.9 months in the control group. The rate of complete response for best overall response, a measure of tumor shrinkage, was comparable across all study participants when measured early in the study at debulking surgery. In a subgroup analysis of patients who received a PARP inhibitor as maintenance therapy, patients in the IMNN-001 treatment arm had a median PFS of 33.8 months versus 22.1 months in the control arm and median OS was not reached for the treatment arm versus 37.1 months for the control arm. IMNN-001 was generally well tolerated, with the most common adverse events primarily gastrointestinal events. Pain management protocols were found to be effective. There were no reports of cytokine release syndrome or any other serious immune related AEs.