The Phase 1 trial evaluating IPH4102 in patients with relapsed or refractory cutaneous T-cell lymphoma has completed its dose escalation part and is preparing to initiate its cohort expansion part.
While results from this part of the trial were not disclosed, Innate Pharma revealed that no dose-limiting toxicity was reported and the maximum tolerated dose was not reached. Innate will present the data in an oral presentation at the upcoming International Conference on Malignant Lymphoma (ICML) June 14-17 in Lugano, Switzerland.
Cutaneous T-cell lymphoma (CTCL) is a heterogeneous disease that accounts for nearly 4 percent of all non-Hodgkin’s lymphoma. The disease is usually diagnosed between the ages of 55 to 65, and is characterized by skin lesions caused by the presence of malignant clonal T-cells.
It’s estimated that approximately 65 percent of CTCL patients — and 85 percent of patients with aggressive CTCL subtypes — express the inhibitory receptor KIR3DL2, which impairs the recruitment of natural killer cells to tumors. This protein has a restricted expression on normal tissues, making it a promising therapeutic target for this disease.
IPH4102 is a first-in-class anti-KIR3DL2 antibody. It binds directly to KIR3DL2-positive cells, inducing their death.
The investigative therapy is currently being evaluated in an open-label Phase 1 trial (NCT02593045) in multiple centers in the U.S., U.K., France, and the Netherlands.
The dose-escalating part of the trial enrolled 25 KIR3DL2-positive CTCL patients in 10 dose cohorts to characterize the safety of IPH4102 and to determine the recommended Phase 2 dose.
A poster presented at the 2016 ASH Annual Meeting revealed the results from the first seven dose levels of this dose-escalating part. The drug was well tolerated and induced an objective response rate of 38 percent. Now the company will be presenting the full data from all 25 patients.
The expansion part of the trial, currently in preparation, will have two cohorts, one for transformed mycosis fungoides and another for Sézary syndrome patients. Each cohort will enroll 15 patients receiving the recommended Phase 2 dose for further confirmation of safety and efficacy.
“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,” Pierre Dodion, chief medical officer of Innate Pharma, said in a press release. “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.”
