Imunon showcases progress on IMNN-001 at R&D Day

IMUNON (IMNN) is presenting an update on recent progress with its IMNN-001 development program for the treatment of newly diagnosed advanced ovarian cancer, including a review of positive data from the Company’s Phase 2 OVATION 2 Study and the minimal residual disease study conducted in partnership with Break Through Cancer. The program will also include updates on trial activation and patient enrollment in the Company’s ongoing Phase 3 OVATION 3 pivotal trial. R&D Day Featured Speakers and Program Highlights: Premal H. Thaker, M.D., Washington University School of Medicine, will discuss the significant continuing unmet needs in ovarian cancer, a devastating disease where patient outcomes and frontline standard of care treatment have not changed for about 30 years, and the promise IMNN-001 brings to these patients and clinicians. She will highlight the data from the Phase 2 OVATION 2 clinical trial, with results including: Broad impact observed with IMNN-001 treatment on important cancer-fighting cytokines, effectively turning the tumor microenvironment from “cold” to “hot” by activating both innate and adaptive immune systems, renewing the elusive promise of an immunotherapy for ovarian cancer. Data reinforcing the highly favorable benefit-risk and safety profile of IMMN 001. The remarkable median 13-month overall survival benefit observed with IMNN-001 plus standard of care chemotherapy, an increase that is considered clinically meaningful compared to SoC alone. Amir Jazaeri, M.D., University of Texas MD Anderson Cancer Center, will discuss safety, tolerability and translational insights from the Phase 2 MRD study of IMNN-001, including: Rationale for the trial and the importance of frontline therapy as the best opportunity to achieve a cure for ovarian cancer. New translational data that clearly show IMNN-001 preferentially being taken up by macrophages within the peritoneal fluid and tumor tissue, which then induces a robust response and tumor microenvironment remodeling. New data further supporting the highly favorable benefit-risk and tolerability profile of IMNN-001. The positive tolerability profile of IMNN-001, including in combination with SoC chemotherapy plus bevacizumab and in the maintenance setting. Giorgio Paulon, Ph.D., Berry Consultants, will review the Phase 2 and ongoing Phase 3 trial designs and the strength of evidence for IMNN-001 from a statistical perspective. He will highlight the well-precedented nature of the Phase 3 design with the FDA, which leverages an innovative, adaptive, event-driven approach aligned with prior successful oncology trials that resulted in full approval by FDA based on interim analyses of overall survival. This foundation, supported by conservative power assumptions drawn from Phase 2 data, strong simulation modeling and robust statistical properties, underpins the Phase 3 trial’s high probability for success. Douglas V. Faller, M.D., Ph.D., IMUNON, will share new data further demonstrating that IMNN-001 shifted the balance in favor of immune stimulation, remodeling the tumor microenvironment in favor of anti-tumor responses, which is established to be associated with better prognosis. He will share the rapid progress to-date on the Phase 3 trial of IMNN-001, including expansion to additional sites and enrollment exceeding the Company’s expectations, strong levels of support and interest from investigators and the scientific community, and key clinical and other milestones for the company moving forward.