Announcement • Jun 23

IMUNON Inc. Continues Phase 3 OVATION 3 Clinical Trial Of IMNN-001 In Combination With Standard Of Care Chemotherapy

IMUNON Inc. announced that the independent Data Monitoring Committee (iDMC) has recommended continuation of the pivotal Phase 3 OVATION 3 clinical trial evaluating IMNN-001 in combination with standard of care neoadjuvant and adjuvant chemotherapy (N/ACT) in women with newly diagnosed advanced ovarian cancer. The pivotal Phase 3 OVATION 3 trial is a robustly designed clinical study with the primary endpoint of overall survival. The trial design includes two planned interim analyses of the primary endpoint, designed to allow for an accelerated timeline for potential submission of a Biologics License Application (BLA) for full approval of IMNN-001 to the U.S. Food and Drug Administration if the primary endpoint reaches statistical significance. With 27 patients enrolled to date, the trial remains on track to complete enrollment of approximately 80 patients by the end of First Quarter 2027. The strong benefit/risk profile, with an advantageous safety profile, has been validated in two successive randomized and controlled clinical trials. OVATION 3 is an ongoing Phase 3 pivotal study to evaluate the dosing, safety, efficacy and biological activity of intraperitoneal administration of IMNN-001 in combination with neoadjuvant and adjuvant chemotherapy (N/ACT) 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 activate the patient’s immune system to recognize and eliminate tumor cells, while also shrinking the tumor as much as possible for optimal surgical removal after three cycles of chemotherapy. Following N/ACT, patients undergo interval debulking surgery, followed by three additional cycles of adjuvant chemotherapy plus IMNN-001 to further stimulate anti-tumor immunity and treat any residual tumor. This randomized controlled study will enroll 500 patients, who will be randomized 1:1 and evaluated for safety and efficacy to compare N/ACT plus IMNN-001 versus standard-of-care N/ACT. In accordance with the study protocol, patients randomized to the IMNN-001 treatment arm can receive up to 17 weekly doses of 100 mg/m2 in addition to N/ACT. The primary endpoint of the trial is overall survival. Additional endpoints include objective response rate, chemotherapy response score, surgical response score, and time to second line therapy. The trial includes two interim analyses for assessment of efficacy, which could potentially serve as opportunities for early registration. OVATION 3 is currently enrolling at multiple sites throughout the US. OVATION 2 evaluated the dosing, safety, efficacy and biological activity of intraperitoneal administration of IMNN-001 in combination with neoadjuvant and adjuvant chemotherapy (N/ACT) 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 N/ACT, 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 N/ACT plus IMNN-001 versus standard-of-care N/ACT. 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 N/ACT. As a Phase 2 study, OVATION 2 was not powered for statistical significance. The Company reported a median 14.7-month increase in overall survival (45.1 vs. 30.4 months) in women in the IMNN-001 treatment arm compared to standard of care alone, demonstrating continuous improvement in overall survival (3.6 delta). In addition, women treated with IMNN-001 and standard of care chemotherapy plus poly ADP-ribose polymerase (PARP) inhibitors as part of maintenance therapy achieved a median increase in overall survival of 24.2 months (65.6 vs. 41.4 months) compared to standard of care chemotherapy alone. With these efficacy results, IMNN-001 continued to maintain a highly favorable safety and tolerability profile. Additional endpoints included objective response rate, chemotherapy response score and surgical response. Designed using IMUNON's proprietary TheraPlas platform technology, IMNN-001 is an IL-12 DNA plasmid vector encased in a nanoparticle delivery system that enables cell transfection followed by persistent, local secretion of the IL-12 protein. IL-12 is one of the most active cytokines for the induction of potent anticancer immunity acting through the induction of T-lymphocyte and natural killer cell proliferation. IMUNON previously reported positive safety and encouraging Phase 1 results with IMNN-001 administered as monotherapy or as combination therapy in patients with advanced peritoneally metastasized primary or recurrent ovarian cancer and completed a Phase 1b dose-escalation trial (the OVATION 1 Study) of IMNN-001 in combination with carboplatin and paclitaxel neoadjuvantly in patients with newly diagnosed ovarian cancer. IMUNON previously reported positive results from the recently completed Phase 2 OVATION 2 Study, which assessed IMNN-001 (100 mg/m2 administered intraperitoneally weekly) plus neoadjuvant and adjuvant chemotherapy (N/ACT) of paclitaxel and carboplatin compared to standard-of-care N/ACT alone in 112 patients with newly diagnosed advanced ovarian cancer.

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Frontline Ovarian Cancer Trial Success Will Transform Long Term Potential For This IL 12 Therapy

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