DNA-Based Immunotherapy IMNN-001 Promises to Improve Survival in Ovarian Cancer

IMUNON announced that its new DNA-based immunotherapy for advanced ovarian cancer has shown encouraging results in the ongoing OVATION 2 trial. The treatment, known as IMNN-001, reportedly boosts levels of crucial cancer-fighting proteins while demonstrating a favourable safety profile in patients.

Increased IL-12 Levels and Encouraging Early Data

The latest findings come from OVATION 2, a Phase 2 study evaluating IMNN-001 in combination with standard chemotherapy—paclitaxel and carboplatin—in women newly diagnosed with advanced ovarian cancer. Researchers reported a 20% rise in levels of the immune-signalling protein interleukin-12 (IL-12) in women who received 100 mg/m^2 of IMNN-001 weekly, compared with those given a 79 mg/m^2 dose.

IMUNON also noted that although the biggest increase in IL-12 was seen within the peritoneal (abdominal) cavity—where ovarian cancer typically spreads—changes in the bloodstream were minimal. This suggests that the therapy directly targets the tumour environment while sparing the rest of the body from excessive immune activation.

Further data revealed corresponding increases in two additional proteins involved in the body’s immune response to cancer—interferon-gamma (IFN-γ) and tumour necrosis factor-alpha (TNF-α). Crucially, no serious immune-related adverse events or signs of cytokine release syndrome were reported, supporting the therapy’s favourable safety profile.

A Potential Game-Changer

“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 Dr. Premal H. Thaker, Interim Chief of Gynecologic Oncology at Washington University and Chair of the OVATION 2 Study.

Survival Benefit and Phase 3 Plans

Last December, IMUNON announced continued improvements in overall survival data from the Phase 2 OVATION 2 Study. Patients who received the higher 100 mg/m^2 dose of IMNN-001 alongside chemotherapy lived a median of 13 months longer than those on standard care alone. More than a third of all trial participants survived beyond 36 months, with the majority of these long-term survivors having received IMNN-001.

Dr. Stacy Lindborg, President and Chief Executive Officer of IMUNON, said the newly released data confirm earlier findings, adding: “We are especially pleased that we continue to observe a highly positive benefit-risk profile of IMNN-001, the first immunotherapy to achieve clinically effective progression-free and overall survival in advanced ovarian cancer in conjunction with chemotherapy.”

She stressed the company’s confidence in the therapy’s foundation technology, known as TheraPlas®, and the plan to move forward with a pivotal Phase 3 trial is on track for early 2025.

In the same announcement, the company detailed its successful End-of-Phase 2 meeting with the US FDA, which supported a pivotal Phase 3 trial. This larger study will employ the 100 mg/m^2 dose of IMNN-001 and is set to begin by the end of the first quarter of 2025.

About the OVATION 2 Study

• Design: Open-label, randomised (1:1) trial evaluating IMNN-001 plus chemotherapy against standard chemotherapy alone.
• Participants: 112 patients newly diagnosed with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer.
• Approach: Patients received three cycles of combination therapy before surgery to shrink tumours (neoadjuvant), followed by surgery and three more cycles (adjuvant).
• Dosing: Up to 17 weekly doses of 100 mg/m^2 IMNN-001 in the treatment arm.
• Endpoints: Safety, objective response rate, surgical response, and chemotherapy response score. As a Phase 2 trial, it was not statistically powered for overall survival significance.