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IMUNON to Present Phase 2 Data of IMNN-001 in Treatment of Newly Diagnosed Ovarian Cancer at SITC 39th Annual Meeting
Results from OVATION 2 Study of IMNN-001 to be highlighted in late-breaking acceptance Company also announces FDA End-of-Phase 2 in-person meeting to discuss
About this update from Imunon, Inc.
[{"type":"text","content":"Results from OVATION 2 Study of IMNN-001 to be highlighted in late-breaking acceptance Company also announces FDA End-of-Phase 2 in-person meeting to discuss Phase 3 trial of IMNN-001 Phase 3 trial is expected to begin in Q1 2025 LAWRENCEVILLE, N.J., Oct. 30, 2024 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage company in late-stage development with its DNA-mediated immunotherapy, today announced the acceptance of a late-breaking presentation featuring new clinical data from the Phase 2 OVATION 2 Study of IMNN-001, its investigational therapy for the treatment of advanced ovarian cancer, at the Society for Immunotherapy of Cancer (SITC) 39th Annual Meeting, being held November 6-10, 2024, in Houston, Texas and virtually. The company also announced plans to hold an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) in person to discuss the design for a Phase 3 pivotal study of IMNN-001 in advanced ovarian cancer, with the trial expected to start in the first quarter of 2025. The company’s lead clinical program IMNN-001, designed using IMUNON’s proprietary TheraPlas® platform technology, 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, inhibition of tumor mediated immune suppression. “We are pleased to have the opportunity to present new data from the Phase 2 OVATION 2 Study of IMNN-001 in a late-breaking session at SITC’s Annual Meeting,” said Stacy Lindborg, Ph.D., president and chief executive officer of IMUNON. “The growing body of evidence supporting IMNN-001 in the treatment of women with advanced ovarian cancer thus far is very encouraging, including the incredibly positive topline data we recently reported showing an 11.1-month increase in median overall survival among patients treated with IMNN-001 compared to patients treated with standard of care, representing a 35% improvement in survival. We look forward to sharing additional data from the OVATION 2 Study, including during our in-person meeting with the FDA to align on the trial design for our planned Phase 3 pivotal...