Innate Pharma has dosed the first patient in a Phase I trial of its antibody-drug conjugate (ADC), IPH4502, which is designed to target tumours expressing Nectin-4.
The Marseille, France-based company describes an IPH4502 topoisomerase I inhibitor that targets Nectin-4, a cell adhesion molecule overexpressed in several types of solid tumours, including urothelial carcinoma, breast cancer, non-small cell lung cancer, and gastrointestinal cancer. The US Food and Drug Administration (FDA) granted investigational new drug (IND) clearance for the trial in September 2024.
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The Phase I open-label, multi-centre study will come in two parts, dose escalation followed by dose optimisation. The main goal of the trial (NCT06781983) is to assess the safety and tolerability of the efficacy of IPH4502 as a single agent in advanced solid tumours. The study plans to enrol 105 patients.
The trial’s investigator, the director of clinical research at NEXT Oncology-Dallas, Dr. Shiraj Sen said: “We are thrilled to initiate the Phase I study with IPH4502, a promising therapy for patients with advanced solid tumours known to express Nectin-4.
“IPH4502 is uniquely designed to target tumours with both high and low expression of Nectin-4, offering hope for improved outcomes in a population where effective treatment options are limited, and relapses occur frequently. This study represents an important step forward in advancing innovative care for these patients.”
Typically ADC treatment combines a mixture of chemo and targeted therapies, usually in response to when tumours return or begin to spread throughout the body. ADC drugs target and destroy particular kinds of proteins usually only found in tumours, whilst preserving the tissue surrounding the tumour. Innate Pharma added that its drug showed good anti-tumour activity as part of in vitro and in vivo tests in pre-clinical studies.
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By GlobalDataSonia Quaratino, chief medical officer at Innate Pharma, added: “The initiation of this Phase 1 trial represents a significant milestone for Innate Pharma as our clinical-stage pipeline now includes targeted ADCs. We are optimistic about the potential of IPH4502 to address unmet needs in the treatment of advanced solid tumours, with a well-differentiated Nectin-4 targeting and the promise of ADC technology to provide a new therapeutic option for patients.”
In March 2024, Innate Pharma shelved development of its anti-KIR3DL2 antibody lacutamab, after a Phase Ib trial (NCT05321147) did not meet the prespecified threshold for meaningful activity. This came months after the FDA placed a partial clinical hold on the drug’s trials in December 2023, following a death from a rare haematologic disorder in a Phase II study (NCT03902184).
Elsewhere in the ADC market, one of the more mainstream treatments produced by Pfizer, Mylotarg, has been part of a BioPharma trial that aims to give the treatment a form of “invisibility cloak.”
