Innate Pharma's IPH4502, a Nectin-4-Targeting ADC, Receives FDA IND Clearance for Phase 1 Solid Tumor Trial
核心洞察
Innate Pharma received FDA clearance for its IND application for IPH4502, an antibody-drug conjugate targeting Nectin-4 (搜索) in solid tumors (搜索).
The Phase 1 trial will evaluate the safety, tolerability, and preliminary efficacy of IPH4502 as a single agent in advanced solid tumors (搜索) expressing Nectin-4 (搜索).
The open-label, multi-center study will include dose escalation and optimization phases to determine the appropriate dosage.
Innate Pharma SA has announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for IPH4502, a novel antibody-drug conjugate (ADC) targeting Nectin-4 (搜索), to commence a Phase 1 clinical trial in patients with advanced solid tumors (搜索). The trial is designed to evaluate the safety, tolerability, and preliminary efficacy of IPH4502 as a single agent. Innate Pharma expects to initiate the Phase 1 study in the coming months.
Trial Design and Objectives
The Phase 1 study will be an open-label, multi-center trial consisting of two parts: a dose escalation phase (Part 1) and a dose optimization phase (Part 2). Patients with advanced solid tumors (搜索) known to express Nectin-4 (搜索) will be enrolled. These include, but are not limited to, urothelial carcinoma (搜索), non-small cell lung (搜索), breast, ovarian, gastric, and colorectal cancers (搜索). The primary objectives of the study are to assess the safety and tolerability of IPH4502, while secondary objectives include evaluating preliminary efficacy.
IPH4502: A Novel Nectin-4 ADC
IPH4502 is a novel topoisomerase I inhibitor ADC conjugated to exatecan targeting Nectin-4 (搜索). Nectin-4 is a cell membrane adhesion protein that is overexpressed in several solid tumors (搜索), including urothelial, breast, esophageal, lung, ovarian, and pancreatic cancers. It exhibits limited expression in normal tissues, making it a promising target for cancer therapy. Preclinical models have demonstrated that IPH4502 is well-tolerated and exhibits anti-tumor efficacy both in vitro and in vivo.
Management Commentary
"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 (搜索) 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 Innate Pharma
Innate Pharma S.A. is a global, clinical-stage biotechnology company focused on developing immunotherapies for cancer patients. The company's innovative approach aims to harness the innate immune system through therapeutic antibodies and its ANKET® (Antibody-based NK cell Engager Therapeutics) proprietary platform. Innate Pharma is headquartered in Marseille, France, with a U.S. office in Rockville, MD. It is listed on Euronext Paris and Nasdaq in the U.S.