IMUNON reported positive Phase 2 MRD study data showing IMNN-001 reduced minimal residual disease and improved ctDNA clearance in advanced ovarian cancer, supporting the ongoing Phase 3 OVATION 3 trial.
Written By: Farha Farheen, PharmD
Reviewed By: Pharmacally Editorial Team
IMUNON has reported encouraging preliminary results from its ongoing Phase 2 translational minimal residual disease (MRD) study evaluating IMNN-001 in combination with standard neoadjuvant and adjuvant chemotherapy plus bevacizumab for women with newly diagnosed advanced epithelial ovarian cancer. The early data showed deeper antitumor responses, higher circulating tumor DNA (ctDNA) clearance, and continued favorable safety, reinforcing the therapeutic potential of IMNN-001 as it advances through the pivotal Phase 3 OVATION 3 (NCT06915025) clinical trial.
The investigator-sponsored study (NCT05739981) is conducted through the Break Through Cancer Targeting Minimal Residual Disease in Ovarian Cancer TeamLab, a multi-institutional collaboration led by The University of Texas MD Anderson Cancer Center. The trial is exploring whether IMNN-001 can remodel the ovarian tumor immune microenvironment and reduce residual disease following frontline treatment.
Preliminary Data Show Lower Residual Disease and Higher ctDNA Clearance
The interim analysis included 18 patients who reached the study’s primary assessment point of second-look laparoscopy (SLL), with nine patients each in the experimental and control arms.
Patients receiving IMNN-001 alongside chemotherapy and bevacizumab demonstrated a lower rate of MRD positivity compared with standard treatment alone (44% versus 67%). Investigators also observed higher ctDNA clearance in the IMNN-001 arm (87.5% versus 62.5%), suggesting a deeper molecular response after frontline therapy.
In addition, all evaluable patients treated with IMNN-001 achieved no evidence of disease (NED) following frontline treatment compared with 56% of patients receiving standard therapy alone. The study plans to enroll 30 patients, with 15 participants assigned to each treatment arm.
IMNN-001 Targets the Ovarian Tumor Microenvironment
IMNN-001 is an intraperitoneally administered IL-12 DNA plasmid immunotherapy developed using IMUNON’s proprietary TheraPlas® nanoparticle delivery platform. Following local administration, the therapy promotes sustained IL-12 production within the peritoneal cavity, activating macrophages, T cells, and natural killer cells while stimulating downstream cytokines such as interferon-gamma.
Translational analyses from the MRD study continue to support the proposed mechanism by demonstrating immune activation consistent with conversion of immunologically “cold” ovarian tumors into a more inflamed, “hot” tumor microenvironment capable of mounting stronger antitumor immune responses.
Safety Findings Remain Consistent
Investigators reported that IMNN-001 maintained a favorable safety and tolerability profile throughout the study, including when administered with chemotherapy, bevacizumab, and subsequent maintenance therapy.
No cytokine release syndrome, systemic toxicities, or serious immune-related adverse events have been reported to date, supporting previous safety observations from earlier clinical studies.
Findings Build on Phase 2 Survival Benefit
The new translational data complement previously reported results from the Phase 2 OVATION 2 trial (NCT03393884), which enrolled 112 patients with newly diagnosed advanced ovarian cancer.
In that study, IMNN-001 improved median overall survival to 45.1 months compared with 30.4 months for chemotherapy alone, representing a 14.7-month survival advantage. Among patients who subsequently received PARP inhibitor maintenance therapy, median overall survival reached 65.6 months versus 41.4 months in the control group, extending survival by 24.2 months.
According to IMUNON President and Chief Executive Officer Stacy Lindborg, Ph.D., the accumulating clinical and translational evidence continues to strengthen confidence in IMNN-001’s benefit-risk profile while addressing historical challenges associated with IL-12-based immunotherapies. Principal investigator Amir Jazaeri, M.D., of MD Anderson Cancer Center noted that reductions in residual disease together with improved ctDNA clearance provide additional support for evaluating IMNN-001 as part of frontline ovarian cancer treatment.
Phase 3 OVATION 3 Trial Continues Enrollment
IMNN-001 is currently being evaluated in the pivotal Phase 3 OVATION 3 trial in women with newly diagnosed advanced ovarian cancer at multiple clinical sites across the United States. The ongoing study is expected to determine whether the survival and translational benefits observed in earlier studies translate into improved clinical outcomes in a larger patient population. If successful, IMNN-001 could represent a novel regional immunotherapy approach for patients with advanced epithelial ovarian cancer, a disease that continues to carry high recurrence rates and limited long-term survival despite current standard treatment.
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About the Writer
Farha Farheen, PharmD (LinkedIn) is a pharmacy professional with a strong interest in pharmacovigilance and clinical research. She has completed her Doctor of Pharmacy (Pharm.D) along with her internship as a Clinical Pharmacist. She has hands-on experience in adverse drug reaction (ADR) reporting, safety data documentation, and pharmacovigilance workflows, and is proficient in using VigiFlow. She is also a patent holder for an antibacterial formulation enriched with bioactive substances, granted by the German Patent and Trademark Office.