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

• 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.