Innate Pharma Gets FDA Clearance for IND of IPH4502, a Nectin-4 ADC for Solid Tumors

MARSEILLE, France, September 23, 2024 — Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) has received clearance from the U.S. Food and Drug Administration (FDA) for its investigational new drug (IND) application. This authorization allows the company to commence a Phase 1 clinical trial for IPH4502, a unique topoisomerase I inhibitor antibody drug conjugate (ADC) targeting Nectin-4 in solid tumors. Innate Pharma plans to start the Phase 1 trial in the upcoming months.

The structure of the Phase 1 study is designed to be open-label and multi-center, comprising two parts: Dose Escalation (Part 1) and Dose Optimization (Part 2). The primary objectives of the study are to evaluate the safety, tolerability, and preliminary effectiveness of IPH4502 as a monotherapy in advanced solid tumors that express Nectin-4. These tumors include but are not limited to urothelial carcinoma, non-small cell lung cancer, breast cancer, ovarian cancer, gastric cancer, and colorectal cancer.

Dr. Sonia Quaratino, Chief Medical Officer of Innate Pharma, expressed enthusiasm about the progress of the IPH4502 program. She noted that the acceptance of the IND application is a crucial milestone for Innate, marking its first ADC program to enter clinical trials. Dr. Quaratino emphasized that IPH4502, a distinct Nectin-4 ADC, has the potential to offer a new therapeutic alternative for patients with various Nectin-4 expressing cancers. The Phase 1 study aims to further the research of ADC technology for patient benefit.

About IPH4502:
IPH4502 is an innovative topoisomerase I inhibitor ADC conjugated to exatecan, targeting Nectin-4. Nectin-4 is a cell membrane adhesion protein significantly overexpressed in several types of solid tumors, including urothelial, breast, esophageal, lung, ovarian, and pancreatic cancers, while its expression in normal tissues is minimal. Non-clinical models have shown that IPH4502 is well tolerated and demonstrates anti-tumor efficacy both in vitro and in vivo.

About Innate Pharma:
Innate Pharma S.A. is a global biotechnology company at the clinical stage, focusing on developing immunotherapies for cancer patients. The company's innovative strategy leverages the innate immune system through therapeutic antibodies and its proprietary ANKET® (Antibody-based NK cell Engager Therapeutics) platform.

Innate Pharma's portfolio includes its leading proprietary program, lacutamab, which is being developed for advanced cutaneous T cell lymphomas and peripheral T cell lymphomas. Additionally, monalizumab, in collaboration with AstraZeneca, is being developed for non-small cell lung cancer. The company also has a suite of multi-specific NK cell engagers under the ANKET® platform to target various tumor types.

Innate Pharma has established itself as a reliable partner for biopharmaceutical companies like Sanofi and AstraZeneca, as well as prominent research institutions. These collaborations aim to accelerate innovation and development, ultimately benefiting patients. Headquartered in Marseille, France, the company also has a U.S. office in Rockville, MD, and is publicly listed on Euronext Paris and Nasdaq in the U.S.