Imunon, Inc. (Lawrenceville, New Jersey; Nasdaq: IMNN) reported preliminary Phase II data for IMNN-001 in newly diagnosed advanced ovarian cancer, drawn from an ongoing minimal residual disease (MRD) translational study. The company said early findings from a small subset of patients showed lower rates of residual disease and higher circulating tumor DNA clearance with the IL-12 gene therapy compared with control, alongside a tolerability profile consistent with prior studies, as Imunon advances its pivotal Phase III OVATION 3 trial in the same population.
At second-look laparoscopy, the study's primary assessment point for surgical MRD, nine patients in each of the control and IMNN-001 arms had been evaluated, out of a target enrollment of 30 patients across both arms. The MRD-positive rate was 44% in the IMNN-001 arm versus 67% in the control arm, and circulating tumor DNA clearance was 87.5% versus 62.5%. All evaluable patients in the IMNN-001 arm achieved no evidence of disease following frontline therapy, compared with 56% of controls. Imunon said no cytokine release syndrome, systemic toxicities, or serious immune-related adverse events have been observed to date in the study.
The Phase II MRD trial (NCT05739981) is an open-label, multi-institutional study conducted with Break Through Cancer, evaluating IMNN-001 administered intraperitoneally alongside neoadjuvant and adjuvant chemotherapy plus bevacizumab, with MRD-positive rate at second-look laparoscopy as the primary endpoint and progression-free survival as a secondary endpoint. The reported figures reflect 18 of the planned 30 patients, and progression-free survival data were not reported. The findings remain preliminary and are based on a subset of enrolled patients, a limitation inherent to interim clinical readouts more broadly.