- Complete safety results and updated clinical activity data will be presented at the ICML 2017 in Lugano in June;
- Preparation for cohort expansion part is ongoing.
Innate Pharma SA (the “Company” - Euronext Paris: FR0010331421 – IPH) today announced that it has completed the dose escalation part of its ongoing Phase I trial evaluating IPH4102 in patients with relapsed/refractory cutaneous T cell lymphomas. No dose-limiting toxicity was reported and the maximum tolerated dose (MTD) was not reached.
Full dose-escalation safety results, as well as updated clinical activity data, will be disclosed in an oral presentation at the upcoming International Conference on Malignant Lymphoma (ICML), in Lugano, Switzerland on June 14 at 5:30 pm.
The abstract entitled “Phase I study of IPH4102, anti-KIR3DL2 mab, in relapsed/refractory cutaneous t-cell lymphomas (CTCL): dose-escalation safety, biomarker and clinical activity results” will be available on the ICML online abstract book on June 7.
The cohort expansion part of the trial in patients with transformed mycosis fungoides and Sézary syndrome, with two cohorts of 15 patients, each receiving IPH4102 at the recommended Phase II dose (RP2D) until progression, will start in the upcoming weeks.
Pierre Dodion, Chief Medical Officer of Innate Pharma, commented: “Although CTCL is an orphan disease, the trial has progressed quickly. We are excited by the promising safety profile and efficacy signals of our antibody in this particularly difficult to treat disease. We look forward to the feedback of regulatory authorities on those data and meanwhile are working on the cohort expansion part of the trial which will start shortly.”
About IPH4102 Phase I trial:
The Phase I trial (NCT02593045) is an open label, multicenter study of IPH4102 in patients with relapsed/refractory CTCL which is performed in Europe (France, Netherlands and United Kingdom) and in the US. Participating institutions include several hospitals with internationally recognized expertise: the Saint-Louis Hospital (Paris, France), the Stanford University Medical Center (Stanford, CA), the Ohio State University (Columbus, OH), the MD Anderson Cancer Center (Houston, Texas), the Leiden University Medical Center (Leiden, Netherlands), and the Guy’s and St Thomas’ Hospital (London, United Kingdom). 55 patients with advanced CTCL having received at least two prior lines of systemic therapy have been and will be enrolled in two sequential study parts:
- The dose-escalation part has accrued 25 KIR3DL2-positive CTCL patients in 10 dose levels. The objective was to characterize IPH4102 safety profile, identify the MTD and/or the RP2D; the dose-escalation followed an accelerated 3+3 design. Preliminary safety and clinical activity results for the first seven dose levels from the dose-escalation part were presented at the 3WCCL and ASH in 2016;
- The cohort expansion part will have 2 cohorts of 15 patients each in 2 CTCL subtypes (transformed mycosis fungoides and Sézary syndrome) receiving IPH4102 at the RP2D until progression.