Innate Pharma Gets US FDA Clearance to Begin Phase 1 Study Of Nectin-4 ADC

Innate Pharma gets US FDA clearance to begin phase 1 study of Nectin-4 ADC, IPH4502 to treat solid tumours

Overview

Innate Pharma SA a global, clinical-stage biotechnology company developing immunotherapies for cancer patients, announced that the US 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 tumours. Innate expects to initiate the phase 1 study in the coming months.

Phase 1 Trial

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 tumours known to express Nectin-4, including but not limited to urothelial carcinoma, non-small cell lung, breast, ovarian, gastric and colorectal cancers.

Words from the CMO: Innate Pharma

• We are thrilled to advance the IPH4502 programme, and the IND application acceptance is an important milestone for Innate, as this is our first ADC programme 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 Antibody

IPH4502 is a novel topoisomerase I inhibitor Antibody Drug Conjugate (ADC) conjugated to exatecan targeting Nectin-4.

About Nectin-4

Nectin-4 is a cell membrane adhesion protein overexpressed in several solid tumours, 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-tumour efficacy in vitro and in vivo.  

About The Company: Innate Pharma S.A.

• Innate Pharma S.A. is a global, clinical-stage biotechnology company developing immunotherapies for cancer patients. 
• Its innovative approach aims to harness the innate immune system through therapeutic antibodies and its ANKET (Antibody-based NK cell Engager Therapeutics) proprietary platform.

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