IMUNON and Break Through Cancer Commence Enrollment in a Phase 1/2 Clinical Study of IMNN 001 in Combination with Avastin in Advanced Ovarian Cancer
February 27, 2023 at 08:30 am EST
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IMUNON, Inc. announced the commencement of patient enrollment in a collaboration to evaluate IMUNON's IMNN-001 (formerly GEN-1) in combination with bevacizumab in patients with advanced ovarian cancer. The trial is now active at the University of Texas MD Anderson Cancer Center. IMNN-001 is a DNA-based interleukin-12 (IL-12) immunotherapy currently in Phase 2 clinical development for the localized treatment of advanced ovarian cancer (the OVATION 2 Study).
This new Phase 1/2 study, titled “A Phase I/II Study Evaluating the Effect of IMNN-001 (IL-12 Plasmid Formulated with PEG-PEI-Cholesterol Lipopolymer) on Minimal Residual Disease (MRD) as determined by Second Look Laparoscopy when Administered in Combination with Bevacizumab and Neoadjuvant Chemotherapy in Subjects Newly Diagnosed with Advanced Ovarian, Fallopian Tube or Primary Peritoneal Cancer” is expected to enroll 50 patients with Stage III/IV advanced ovarian cancer and is being led by principal investigator Amir Jazaeri, M.D., Professor of Gynecologic Oncology and Reproductive Medicine at MD Anderson. Patients undergoing frontline neoadjuvant therapy will be randomized 1:1 to receive standard chemotherapy vs. chemotherapy plus IMNN-001.
The 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 from the completion of enrollment and final PFS data are expected approximately three years from 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.
Imunon, Inc. is a clinical-stage biotechnology company. The Company is focused on advancing a portfolio of treatments that harness the bodyâs natural mechanisms across an array of human diseases. The Company is developing non-viral Deoxyribonucleic acid (DNA) technology across four modalities. The first modality, TheraPlas, is developed for the coding of proteins and cytokines in the treatment of solid tumors. The second modality, PlaCCine, is developed for the coding of viral antigens that can elicit a strong immunological response. The third modality, FixPlas, concerns the application of Imunonâs DNA technology to produce universal cancer vaccines, also called tumor associated antigen cancer vaccines. The fourth modality, IndiPlas, is in the discovery phase and is focused on the development of personalized cancer vaccines, or neoepitope cancer vaccines. Its lead clinical program, IMNN-001, is a DNA-based immunotherapy for the localized treatment of advanced ovarian cancer.
IMUNON, INC. 
