Site Editor
Joyce F. Liu, MD, MPH
Joyce F. Liu, MD, MPH
Posted: Monday, April 21, 2025
New translational data have been announced from the phase I/II OVATION 2 study, which is studying IMNN-001—an interleukin-12 (IL-12) DNA plasmid vector encased in a nanoparticle delivery system that enables cell transfection followed by local secretion of the IL-12 protein. According to the manufacturer (Imunon), the dose-dependent mechanism with this agent at 100 mg/m2 was associated with a 20% increase in IL-12 levels compared with a dose of 79 mg/m2 when given with standard chemotherapy. A phase III trial is planned for early 2025.
The data showed increased levels of anticancer immune cytokines IFN-γ and TNF-α in the tumor microenvironment. Results noted no reports of serious immune-related adverse events including cytokine-release syndrome. Previous results reported in December 2024 showed a 13-month improvement in median overall survival with IMNN-001 plus standard care vs standard care alone. More than one-third of patients were alive beyond 36 months, with 62% from the investigational treatment arm. More than 10% of trial participants have reached 48 months or beyond.
“The increases in levels of IL-12 and positive downstream effects on IFN-γ and TNF-α indicate that IMNN-001 treatment is having a broad impact on important cancer-fighting cytokines and effectively targeting the tumor microenvironment, with limited to no systemic toxicities,” said Premal H. Thaker, MD, Interim Chief of Gynecologic Oncology, David & Lynn Mutch Distinguished Professor of Obstetrics & Gynecology, Director of Gynecologic Oncology Clinical Research at Washington University School of Medicine, and the OVATION 2 Study Chair.
The OVATION 2 trial evaluated the dosing, safety, efficacy, and biological activity of intraperitoneal administration of IMNN-001 in combination with neoadjuvant and adjuvant chemotherapy of paclitaxel and carboplatin in patients newly diagnosed with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer. Following neoadjuvant chemotherapy, patients underwent interval debulking surgery, followed by three additional cycles of adjuvant chemotherapy to treat any residual tumor. This open-label study enrolled 112 patients who were randomly assigned 1:1 to neoadjuvant chemotherapy plus IMNN-001 vs standard-of-care neoadjuvant chemotherapy.
