Memorial Sloan Kettering Cancer Center has joined MD Anderson Cancer Center in enrolling patients in a Phase 1/2 clinical trial evaluating IMUNON’s IMNN-001 in combination with bevacizumab for advanced ovarian cancer. This trial aims to assess the impact of this combination therapy on minimal residual disease (MRD).
Trial Design and Objectives
The Phase 1/2 trial is designed to enroll 50 patients with Stage III/IV advanced ovarian cancer. Participants undergoing frontline neoadjuvant therapy will be randomized in a 1:1 ratio to receive either standard chemotherapy plus bevacizumab or chemotherapy plus bevacizumab and IMNN-001. The primary endpoint of the trial is the detection of MRD by second-look laparoscopy (SLL), while the secondary endpoint is progression-free survival (PFS).
Anticipated Outcomes and Translational Endpoints
Initial SLL data are expected within one year following the completion of enrollment, and final PFS data are anticipated approximately three years after enrollment completion. The trial will also incorporate translational endpoints to understand the clonal evolution and immunogenomic features of the MRD phase of ovarian cancer, which is often undetectable by imaging or tumor markers.
IMNN-001: An IL-12 DNA-Based Immunotherapy
IMNN-001 is a DNA-based interleukin-12 (IL-12) immunotherapy. It utilizes IMUNON’s TheraPlas® platform technology, which involves an IL-12 DNA plasmid vector encased in a nanoparticle delivery system. This system enables cell transfection, leading to persistent, local secretion of the IL-12 protein. IL-12 is known for its potent anticancer immunity induction through the proliferation of T-lymphocytes and natural killer cells.
The Need for Improved Ovarian Cancer Treatments
Epithelial ovarian cancer (EOC) remains a significant challenge, being the fifth deadliest malignancy among women in the United States. Approximately 70% of the 22,000 new cases diagnosed annually are in advanced Stages III and IV. These advanced stages are characterized by tumor dissemination in the peritoneal cavity and a high recurrence risk (75%) following surgery and chemotherapy. The five-year survival rates for patients with Stages III and IV disease are 41% and 20%, respectively, highlighting the urgent need for therapies that reduce recurrence and improve overall survival.
Management Commentary
Dr. Corinne Le Goff, President and Chief Executive Officer of IMUNON, stated, “We are delighted that such a prestigious institution as Memorial Sloan Kettering has joined this trial, which is testing the combination of IMNN-001 and bevacizumab, known as Avastin™ in ovarian cancer. We believe this combination therapy holds promise based on our preclinical animal studies, which showed strong synergies between IMNN-001 and bevacizumab... As an innovative immunotherapy, IMNN-001 may transform the first-line treatment of ovarian cancer and provide new options to women diagnosed with Stage III/IV disease who face cure rates of 15% or less.”
