IMUNON Reports Interim Progression-Free Survival and Overall Survival Data in Phase 1/2 OVATION 2 Study in Advanced Ovarian Cancer

Intent-to-treat population shows 9-month OS improvement over control arm

Subgroup of patients treated with IMNN-001 + PARPi shows meaningful PFS and OS trend compared with control arm

Continued follow-up is indicated to confirm initial observations

LAWRENCEVILLE, N.J., Sept. 28, 2023 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage biotechnology company focused on developing DNA-mediated immunotherapies and next-generation vaccines, announces interim progression-free survival (PFS) and overall survival (OS) data with IMNN-001 in its Phase 1/2 OVATION 2 Study. IMNN-001 is the Company’s IL-12 gene-mediated immunotherapy based on its TheraPlas technology. Full enrollment of 110 patients was reached in September 2022.

OVATION 2 is evaluating the dosing, safety, efficacy and biological activity of intraperitoneal IMNN-001 in combination with neoadjuvant chemotherapy (NACT) in patients newly diagnosed with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer. NACT is designed to shrink the tumors as much as possible for optimal surgical removal after three cycles of chemotherapy. Following NACT, patients undergo interval debulking surgery, followed by three additional cycles of chemotherapy to treat any residual tumor.

As expected for a Phase 1/2 study, the study is directional and was designed with an 80% confidence interval to show an approximate 33% improvement in PFS, when comparing the treatment arm (NACT + IMNN-001) with the control arm (NACT only). The secondary endpoints include OS, objective response rate (ORR), pathological response, surgical response and serologic response. The study was not powered for p values of 0.05. The final readout of this study is expected by mid-2024. A positive readout would inform next development steps.

Interim data from the intent-to-treat (ITT) population being reported today show efficacy trends in PFS, demonstrating a delay in disease progression in the treatment arm of approximately 33% compared with the control arm, with the hazard ratio nearing the required value. Preliminary OS data follows a similar trend, showing an approximate 9-month improvement in the treatment arm over the control arm.

Subgroup analyses show patients treated with a PARP inhibitor (PARPi) as maintenance therapy had longer PFS and OS if they were also treated with IMNN-001 compared with patients treated with NACT only. This was not a pre-specified subgroup as PARP inhibitors were approved after the OVATION 2 Study was initiated.