Imunon

IMUNON, Inc. announced positive outcomes from a Type C CMC meeting with the FDA regarding IMNN-001 production for a Phase 3 trial and potential BLA submission, aligning on key CMC topics. The company remains on track to initiate the Phase 3 trial in Q1 2025, aiming for commercialization of IMNN-001 for advanced ovarian cancer treatment.

IMUNON announced a successful Type C CMC meeting with the FDA for IMNN-001, a DNA-mediated immunotherapy for advanced ovarian cancer. The FDA aligned with IMUNON's manufacturing strategy and requirements for a 500-patient Phase 3 trial starting Q1 2025. Key outcomes include FDA acceptance of the potency assay measuring interferon-gamma and agreement on manufacturing comparability strategy. Manufacturing will be handled at IMUNON's Huntsville, Alabama facility.

The OVATION-2 trial showed an 11.1-month improvement in overall survival with IL-12 immunotherapy IMNN-001 plus chemotherapy vs. chemotherapy alone in advanced ovarian cancer patients. A phase 3 trial is planned for Q1 2025, with hopes of bringing a new treatment to market.

IMUNON, Inc. announces FDA support for Phase 3 trial of IL-12 immunotherapy IMNN-001 for advanced ovarian cancer, with trial initiation planned for Q1 2025. Positive Phase 2 results showed improved overall survival and tolerability.

IMUNON, Inc. announces FDA support for Phase 3 trial of IMNN-001, an IL-12 immunotherapy for advanced ovarian cancer, with trial initiation planned for Q1 2025.

IMNN-001 immunotherapy plus chemotherapy improved overall survival by 35% and progression-free survival by 25% in advanced ovarian cancer patients. Treatment was well-tolerated, with no serious immune-related adverse events. IMUNON plans to initiate a Phase 3 trial in Q1 2025.

IMUNON reported Q3 2024 financial results, highlighting progress with IMNN-001 in advanced ovarian cancer and IMNN-101, a seasonal COVID-19 booster. IMNN-001 showed an 11.1-month OS improvement in OVATION 2 Study, with plans to start a Phase 3 study in Q1 2025. The company raised $10 million in a registered direct financing and added key leadership to support operational excellence.

IMUNON, Inc. announces late-breaking presentation of Phase 2 OVATION 2 Study data of IMNN-001 for advanced ovarian cancer at SITC 39th Annual Meeting. The company also plans an in-person FDA End-of-Phase 2 meeting to discuss the Phase 3 trial design, expected to start in Q1 2025.

IMUNON's Phase 2 OVATION 2 Study of IMNN-001 showed an 11.1-month increase in median overall survival, a 35% improvement, to be presented at SITC's 39th Annual Meeting. The company plans to discuss Phase 3 trial design with the FDA in Q1 2025.