Study of IMNN-001 (Also Known as GEN-1) With NACT for Treatment of Ovarian Cancer (OVATION 2)

Summary

This is a randomized, open label, multicenter trial to evaluate the safety, dosing, efficacy and biological activity of intraperitoneal IMNN-001 plus NACT compared to NACT alone.

Timeline

Start

2018-09-05

Primary completion

2024-07-25

Completion

2026-05-30

Outcome

Results reported · no primary-endpoint met/missed verdict (typical of a dose-finding / safety study)

release “median overall survival among women treated with IMNN-001 in the OVATION 2 trial rose from the previously reported 11.1 months to 14.7 months” imunon.com ↗

Publications

• Thaker PH, Richardson DL, Hagemann AR, Holloway RW, Reed M, Bergman MK, Pothuri B, DePasquale S, Scalici JM, Bregar AJ, Darus CJ, Finkelstein K, Leath CA 3rd, Bell M, Warshal DP, Agajanian R, Indermaur MD, Mendivil AA, Provencher DM, Wei LJ, Borys N, Musso L, Lindborg SR, Faller DV, Anwer K, Bradley WH. OVATION-2: A randomized phase I/II study evaluating the safety and efficacy of IMNN-001 (IL-12 gene therapy) with neo/adjuvant chemotherapy in patients newly-diagnosed with advanced epithelial ovarian cancer. Gynecol Oncol. 2025 Jun;197:182-191. doi: 10.1016/j.ygyno.2025.04.578. Epub 2025 Jun 3.
• Yin X, Davi R, Lamont EB, Thaker PH, Bradley WH, Leath CA 3rd, Moore KM, Anwer K, Musso L, Borys N. Historic Clinical Trial External Control Arm Provides Actionable GEN-1 Efficacy Estimate Before a Randomized Trial. JCO Clin Cancer Inform. 2023 Jan;7:e2200103. doi: 10.1200/CCI.22.00103.

Drugs

Indications