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An independent safety committee has cleared a Phase 2 trial of IMNN-001, an IL-12-based immunotherapy, to continue without changes in advanced ovarian cancer. Early data from 9 patients per arm show IMNN-001 outperforming standard care on key measures like MRD negativity and ctDNA clearance — all without triggering the serious immune side effects that have historically plagued IL-12 therapies.
An independent data monitoring committee (IDMC) has reviewed all safety data from the ongoing Phase 2 minimal residual disease (MRD) study of IMNN-001 in newly diagnosed advanced ovarian cancer and recommended the trial continue without modification. No new safety signals were identified — a significant milestone for an IL-12-based therapy, given that systemic IL-12 has historically caused serious toxicities like cytokine release syndrome.
IMNN-001 is an IL-12 DNA plasmid delivered via nanoparticle directly into the peritoneal cavity, designed to produce localized, sustained cytokine activity without the systemic side effects. The trial is testing it alongside standard neoadjuvant/adjuvant chemotherapy and bevacizumab, with second-look laparoscopy used to assess for residual disease.
By the Numbers:
Why it matters: These early results suggest IMNN-001 may meaningfully improve disease clearance in a notoriously difficult-to-treat cancer — and without the immune toxicities that have long limited IL-12 therapies. A pivotal Phase 3 trial (OVATION-3) is already underway.