Innate Pharma gets US FDA Nod to begin phase 1 study of Nectin-4 ADC

Innate Pharma SA, a worldwide biotech firm in clinical stages advancing cancer immunotherapies, reported that the FDA has approved its IND application for a phase 1 clinical trial of IPH4502, a unique topoisomerase I inhibitor ADC targeting Nectin-4 in solid tumors. Innate plans to start the phase 1 study in the upcoming months.

The phase 1 study involves a Part 1 Dose Escalation and a Part 2 Dose Optimization to evaluate the safety, tolerability, and initial effectiveness of IPH4502 in advanced solid tumors that express Nectin-4, such as urothelial carcinoma, non-small cell lung, breast cancer, ovarian, gastric, and colorectal cancers.

“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.”

IPH4502 is a new ADC conjugated to exatecan that targets Nectin-4, acting as a topoisomerase I inhibitor. Nectin-4, a membrane adhesion protein, is found in high levels in various solid tumors such as urothelial, breast, esophageal, lung, ovarian, and pancreatic cancers, while being less present in healthy tissues.