Thaker PH, Bradley WH, Leath CA, Gunderson Jackson C, Borys N, Anwer K, Musso L, Matsuzaki J, Bshara W, Odunsi K, Alvarez RD. GEN-1 in Combination with Neoadjuvant Chemotherapy for Patients with Advanced Epithelial Ovarian Cancer: A Phase I Dose-escalation Study. Clinical cancer research : an official journal of the American Association for Cancer Research. 2021 Dec 15;27(27). 5536-5545. PMID: 34326131 [PubMed] PMCID: PMC9338778 NIHMSID: NIHMS1822459.
GEN-1 (phIL-12-005/PPC), an IL12 plasmid formulated with polyethyleneglycol-polyethyleneimine cholesterol lipopolymer, has preclinical activity when combined with platinum-taxane intravenous chemotherapy and administered intraperitoneally in epithelial ovarian cancer (EOC) models. OVATION I was a multicenter, nonrandomized, open-label phase IB trial to evaluate the safety, preliminary antitumor activity, and immunologic response to GEN-1 in combination with neoadjuvant chemotherapy (NACT) carboplatin-paclitaxel in patients with advanced EOC.