Core Viewpoint - IMUNON, Inc. has initiated the pivotal Phase 3 OVATION 3 Study for its lead candidate IMNN-001, aimed at treating newly diagnosed advanced ovarian cancer, with the first patient dosed [1][2]. Company Overview - IMUNON is a clinical-stage biotechnology company focused on innovative treatments that utilize the body's natural mechanisms for effective disease responses [8]. - The company is advancing its non-viral DNA technology, with its first modality, TheraPlas, designed for gene-based delivery of cytokines in solid tumors [8][9]. Product Development - IMNN-001 is a DNA-mediated immunotherapy that has shown significant therapeutic potential in previous clinical trials, including improvements in overall survival and progression-free survival [2][3]. - The Phase 3 OVATION 3 trial will assess IMNN-001 in combination with standard chemotherapy, targeting women with advanced ovarian cancer [1][4]. Clinical Trial Details - The OVATION 3 trial will randomize participants 1:1 to receive either IMNN-001 plus neoadjuvant/adjuvant chemotherapy or standard chemotherapy alone, focusing on overall survival as the primary endpoint [1][4]. - The Phase 2 OVATION 2 Study demonstrated consistent improvements in key endpoints, including overall survival and safety profile, with 112 patients enrolled [3][4]. Mechanism of Action - IMNN-001 utilizes a proprietary TheraPlas platform to deliver IL-12, a potent cytokine that induces strong anti-cancer immunity by promoting T-lymphocyte and natural killer cell proliferation [6][9]. - Recent data indicates that IMNN-001 creates a "hot" anti-tumor microenvironment by recruiting immune cells to the tumor site, enhancing its therapeutic efficacy [3][6]. Market Context - Epithelial ovarian cancer is a significant health concern, with approximately 20,000 new cases annually in the U.S., and a high percentage diagnosed at advanced stages [7]. - The need for effective therapies is critical, as current options primarily include chemotherapy and surgery, with poor five-year survival rates for advanced stages [7].

Core Points - IMUNON, Inc. is a clinical-stage biotechnology company focused on DNA-mediated immunotherapy, currently in Phase 3 development [1][4] - The company will present at the Zacks SCR Life Sciences Virtual Investor Forum on June 12, 2025, at 11:30 a.m. ET [1] - IMUNON's lead clinical program, IMNN-001, is a DNA-based immunotherapy targeting advanced ovarian cancer, having completed multiple clinical trials including a Phase 2 trial [5] Company Overview - IMUNON is developing innovative treatments that utilize the body's natural mechanisms to generate effective responses against various diseases, differentiating from conventional therapies [4] - The company is advancing its non-viral DNA technology through two main modalities: TheraPlas for gene-based delivery of cytokines and PlaCCine for gene delivery of viral antigens [4] Clinical Programs - IMNN-001 instructs the body to produce cancer-fighting molecules at the tumor site, specifically interleukin-12 and interferon gamma [5] - The company has also completed dosing in a first-in-human study of its COVID-19 booster vaccine, IMNN-101 [5] - IMUNON aims to leverage its technologies to address difficult-to-treat conditions, either directly or through partnerships [5]