Innate Pharma Completes Enrollment in Phase 1 Dose Escalation of IPH4502, a Novel Nectin-4 Exatecan ADC, with Preliminary Data Expected by Year-End
核心洞察
Innate Pharma completed enrollment of 76 patients in the dose escalation portion of the Phase 1 IPH4502-101 study across sites in France and the United States.
IPH4502, a Nectin-4 (搜索)-targeting ADC with an exatecan payload and proprietary linker, has shown a favorable safety profile with limited hematological toxicity to date.
Objective responses were observed in heavily pre-treated patients with post-enfortumab vedotin urothelial carcinoma (搜索), non-small cell lung cancer (搜索), and head and neck squamous cell carcinoma (搜索).
Innate Pharma SA announced the completion of enrollment in the dose escalation portion of its Phase 1 IPH4502-101 study, marking a significant milestone for the company's proprietary Nectin-4 (搜索)-targeted antibody-drug conjugate (ADC). The open-label, multi-center trial (NCT06781983) has recruited 76 patients across France and the United States, with preliminary data readout anticipated by year-end.
The Phase 1 study is evaluating the safety, tolerability, and preliminary anti-tumor activity of IPH4502 as a single agent in patients with advanced solid tumors known to express Nectin-4 (搜索). Eligible tumor types include, but are not limited to, urothelial carcinoma (搜索) (UC), non-small cell lung cancer (搜索) (NSCLC), head and neck squamous cell carcinoma (搜索) (HNSCC), breast, ovarian, gastric, esophageal, and colorectal cancers.
Favorable Safety Profile and Early Efficacy Signals
To date, IPH4502 continues to demonstrate a favorable safety profile, with limited hematological toxicity. The company attributes this to its proprietary linker, which is designed to slow the release of free exatecan into the circulation, thereby minimizing toxicity. Preliminary anti-tumor activity has been observed in heavily pre-treated patients with advanced solid tumors, with objective responses reported in UC post-enfortumab vedotin (EV), as well as in NSCLC and HNSCC.
"Completing enrollment in the dose escalation marks an important milestone for IPH4502. The data generated to date continue to support the differentiated design of IPH4502, notably through the limited hematological toxicity observed to date, which we believe might reflect the benefits of our proprietary linker. We look forward to the dose escalation dataset by year-end, which will guide our path into dose optimization and further define the clinical potential of IPH4502," said Sonia Quaratino, EVP Chief Medical Officer of Innate Pharma.
Differentiated ADC Design
IPH4502 is built on three differentiated components. The payload is exatecan, a potent topoisomerase I inhibitor, selected for its potential to overcome key limitations associated with monomethyl auristatin E (MMAE)-based ADCs, including multidrug resistance protein 1 (MDR1)-mediated resistance, and without the need for CYP2D6 genotyping. The ADC incorporates a proprietary stable linker designed to slow the release of free exatecan into the circulation. The binder is a proprietary humanized anti-Nectin-4 (搜索) antibody with high affinity and a distinct, non-overlapping epitope compared with enfortumab vedotin.
In preclinical studies, IPH4502 demonstrated anti-tumor activity in EV-resistant tumor models and in tumors with low and heterogeneous Nectin-4 (搜索) expression, supporting its potential applicability across solid tumor types beyond UC.
Next Steps
The preliminary dataset from the dose escalation phase, encompassing all 76 patients, is expected by year-end and will inform the dose optimization strategy in selected tumor types. Innate Pharma, headquartered in Marseille, France, with a US office in Rockville, MD, is listed on Euronext Paris and Nasdaq under the ticker IPH and IPHA, respectively.