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IMUNON Announces Database Lock for Phase 2 OVATION 2 Study with IMNN-001 in Advanced Ovarian Cancer
Novel IL-12 Immunotherapy Administered with Standard of Care as First-Line Treatment Expects topline results by the end of July LAWRENCEVILLE, N.J., June 24,
About this update from Imunon, Inc.
[{"type":"text","content":"Novel IL-12 Immunotherapy Administered with Standard of Care as First-Line Treatment Expects topline results by the end of July LAWRENCEVILLE, N.J., June 24, 2024 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage company in advanced development of its non-viral DNA-mediated immunotherapy, announces database lock for its Phase 2 OVATION 2 Study evaluating the safety and efficacy of IMNN-001 in patients with advanced ovarian cancer. Median Overall Survival (OS) and Progression Free Survival (PFS) have been reached and all patients in the open-label study have achieved treatment observation duration of 16 months, as required per protocol to evaluate efficacy. The independent statisticians have received the raw trial data and will follow the statistical analysis plan as they analyze the data from the trial. IMUNON expects to report topline results including hazard ratios before the end of July 2024. OVATION 2 is evaluating the dosing, safety, efficacy and biological activity of intraperitoneal administration of IMNN-001 in combination with neoadjuvant chemotherapy (NACT) 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. Patients were randomized 1:1 and evaluated for safety and efficacy to compare NACT plus IMNN-001 versus standard-of-care NACT. Patients randomized to the IMNN-001 treatment arm received up to 17 doses of 100 mg/m2, in addition to NACT. Full enrollment of 110 patients was reached in September 2022. The OVATION 2 Study is meant to inform the design of the intended Phase 3 trial and was not powered for statistical significance. Per the Statistical Analysis Plan (SAP), the primary efficacy analysis will be based on the Intent to Treat (ITT) population. The primary efficacy endpoint is PFS, with secondary endpoints including OS, Objective Response Rate, Chemotherapy Response Score and Surgical Response. Stacy Lindborg, Ph.D., president and chief executive officer of IMUNON, said, “Reaching data lock for the OVATION 2 Study is a significant achievement...