drugset / Press release

Innate Pharma announces FDA clearance of the IND for IPH4502, a Nectin-4 ADC to be developed in solid tumors

2024-09-23 · Innate Pharma · original innate-pharma.com ↗

IPH4502 is Innate’s novel and differentiated topoisomerase I inhibitor antibody drug conjugate (ADC) targeting Nectin-4 Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) (“ Innate ” or the “ Company ”) today announced that the U.S Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application to initiate a Phase 1 clinical study of IPH4502, its novel and differentiated topoisomerase I inhibitor antibody drug conjugate (ADC) targeting Nectin-4 in solid tumors. Innate expects to initiate the Phase 1 study in the coming months. The Phase 1, open-label, multi-center study, includes a Part 1 Dose Escalation and a Part 2 Dose Optimization, and will assess the safety, tolerability, and preliminary efficacy of IPH4502 as a single agent in advanced solid tumors known to express Nectin-4, including but not limited to urothelial carcinoma, non-small cell lung, breast, ovarian, gastric and colorectal cancers. “ We are thrilled to advance the IPH4502 program, and the IND application acceptance is an important milestone for Innate, as this is our first ADC program to enter the clinic, ” said Dr Sonia Quaratino, Chief Medical Officer of Innate Pharma . “ IPH4502 is a novel and differentiated Nectin-4 ADC that has the potential to provide a new therapeutic option for patients with a cancer expressing a wide range of Nectin-4. Through this Phase 1 study we aim to advance the research on our ADC technology for the benefit of patients .” About IPH4502 IPH4502 is a novel topoisomerase I inhibitor Antibody Drug Conjugate (ADC) conjugated to exatecan targeting Nectin-4. Nectin-4 is a cell membrane adhesion protein overexpressed in several solid tumors, including urothelial, breast, esophageal, lung, ovarian, and pancreatic cancers, with limited expression in normal tissues. In non-clinical models, IPH45 was well tolerated and shows anti-tumor efficacy in vitro and in vivo. Subscribe to our newsletter Contact us 117, Avenue de Luminy - BP 30191 13 009 Marseille FRANCE +33 (0)4 30 30 30 30

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