IMUNON Finalizes Phase 3 Study Design with FDA for IMNN-001 in Newly Diagnosed Advanced Ovarian Cancer

About this update from Imunon, Inc.

[{"type":"image","alt":"Imunon, Inc.","displaySize":"","headline":null,"caption":"Imunon, Inc.","className":"","disableSlideshowImg":false,"size":{"original":{"width":290,"height":91,"url":"https://media.zenfs.com/en/globenewswire.com/512f8d6fe64afe67e274ac86630ade62"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/pOVE3xhQvQP6wH..j_xlsw--/YXBwaWQ9aGlnaGxhbmRlcjt3PTQyMDtoPTEzMjtjZj13ZWJw/https://media.zenfs.com/en/globenewswire.com/512f8d6fe64afe67e274ac86630ade62","width":290,"height":91}},"lazy":false},{"type":"text","content":"First and only immunotherapy to show meaningful overall survival benefit in a Phase 2 trial in patients with advanced ovarian cancer","length":132,"tagName":"p"},{"type":"text","content":"Initiation of trial sites underway for ground-breaking Phase 3 pivotal trial of DNA-mediated IL-12 therapeutic","length":110,"tagName":"p"},{"type":"text","content":"Company to hold conference call on Tuesday, March 25, 2025, at 2:00 p.m. ET","length":75,"tagName":"p"},{"type":"text","content":"LAWRENCEVILLE, N.J., March 24, 2025 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage company in Phase 3 development with its DNA-mediated immunotherapy, today announced that the U.S. Food and Drug Administration (FDA) is aligned with the protocol for the Phase 3 pivotal trial, called OVATION 3, of its lead candidate IMNN-001 in development for the treatment of women with newly diagnosed advanced ovarian cancer. The company is currently initiating trial sites and working with trial investigators to begin enrolling study participants.","length":555,"tagName":"p"},{"type":"text","content":"“We are grateful for the ongoing guidance and support from the FDA and are very pleased that the agency is fully aligned on our plans related to the Phase 3 trial,” said Stacy Lindborg, Ph.D., president and chief executive officer of IMUNON. “The Phase 2 OVATION 2 study data are highly encouraging, demonstrating that IMNN-001 is the first immunotherapy to achieve a clinically effective response in ovarian cancer, including benefits in both progression-free and overall survival in frontline treatment, and we continue to observe strong improvements with additional monitoring and follow-up of patients. We look forward to potentially replicating these unprecedented results in the Phase 3 OVATION 3 study. We are currently initiating trial sites and ar...

More updates from Imunon, Inc.