IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage drug-development company focused on developing non-viral DNA-mediated immunotherapy and next-generation vaccines, announces that 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 in patients with advanced ovarian cancer. IMNN-001 is a DNA-based interleukin-12 (IL-12) immunotherapy currently in the Phase 2 OVATION 2 Study for the localized treatment of advanced ovarian cancer.
Dr. Corinne Le Goff, President and Chief Executive Officer of IMUNON, said, “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.”
This Phase 1/2 trial is designed to enroll 50 patients with Stage III/IV advanced ovarian cancer. Patients undergoing frontline neoadjuvant therapy will be randomized 1:1 to receive standard chemotherapy plus bevacizumab vs. chemotherapy plus bevacizumab and IMNN-001. The trial’s primary endpoint is detection of minimal residual disease (MRD) by second-look laparoscopy (SLL), and the secondary endpoint is progression-free survival (PFS).
Initial SLL data are expected within one year following the completion of enrollment and final PFS data are expected approximately three years following the completion of enrollment. This trial will also include a wealth of translational endpoints aimed at understanding the clonal evolution and immunogenomic features of the MRD phase of ovarian cancer that is currently undetectable by imaging or tumor markers.
The trial’s principal investigator is Amir Jazaeri, M.D., Professor of Gynecologic Oncology and Reproductive Medicine at The University of Texas MD Anderson Cancer Center. The Koch Institute for Integrative Cancer Research at the Massachusetts Institute of Technology will also be involved in translational analyses using trial samples and animal models of ovarian cancer MRD, including biomarker and genomic analyses, which is expected to expand the Company’s knowledge of the treatment paradigm. These initiatives are a part of the Break Through Cancer Targeting Ovarian Cancer Minimal Residual Disease Using Immune and DNA Repair Directed Therapies TeamLab collaboration.
Dr. Le Goff added, “We are excited about the potential for IMNN-001 in ovarian cancer, in particular following our recently announced encouraging interim PFS and overall survival data for our OVATION 2 Study evaluating the benefits of IMNN-001 in the neoadjuvant setting.”
