FDA Clears Innate Pharma’s IND for IPH4502 Targeting Nectin-4 in Solid Tumors

Innate Pharma SA has received clearance from the U.S. Food and Drug Administration (FDA) to initiate a Phase 1 clinical trial for IPH4502, its innovative topoisomerase I inhibitor antibody-drug conjugate (ADC) targeting Nectin-4 in solid tumors. The Phase 1 study, set to begin in the coming months, will evaluate the safety, tolerability, and preliminary efficacy of IPH4502 in advanced tumors that express Nectin-4, such as urothelial carcinoma, non-small cell lung cancer, breast, ovarian, gastric, and colorectal cancers.

This open-label, multi-center study will be conducted in two parts: dose escalation and dose optimization. The aim is to determine the potential of IPH4502 as a new therapeutic option for cancers expressing Nectin-4. According to Dr. Sonia Quaratino, Chief Medical Officer of Innate Pharma, this trial marks an important milestone for the company, being their first ADC program to enter clinical trials.

IPH4502 is designed to target Nectin-4, a cell adhesion protein that is overexpressed in various solid tumors, with minimal expression in normal tissues. Non-clinical studies have shown that IPH4502 has promising anti-tumor activity both in vitro and in vivo.