Preliminary data from 76 patients are expected by year-end, with early signs of objective responses and a favorable safety profile in advanced Nectin-4-expressing solid tumors.
Innate Pharma said it has completed enrollment in the dose-escalation part of the Phase 1 IPH4502-101 study of IPH4502, its proprietary Nectin-4 exatecan antibody-drug conjugate. Preliminary data from 76 patients in France and the United States are expected by year-end and are intended to guide Phase 1 dose optimization in selected tumor types. The open-label, multi-center trial is evaluating safety, tolerability and preliminary anti-tumor activity in patients with advanced solid tumors known to express Nectin-4, including urothelial carcinoma, non-small cell lung cancer, head and neck squamous cell carcinoma, breast, ovarian, gastric, esophageal and colorectal cancers. Innate said IPH4502 has shown a favorable safety profile to date, with limited hematological toxicity, while objective responses have been observed in heavily pre-treated patients with urothelial carcinoma after enfortumab vedotin, as well as in non-small cell lung cancer and head and neck squamous cell carcinoma. The company says the candidate combines a proprietary anti-Nectin-4 antibody, a stable linker designed to slow release of free exatecan into circulation, and an exatecan payload intended to address some limitations seen with MMAE-based ADCs.