Innate Pharma announces U.S. FDA lifts partial clinical hold on lacutamab clinical program

Innate Pharma SA announced that the U.S. Food and Drug Administration (FDA) has lifted the partial clinical hold placed on the lacutamab IND. On October 5, Innate announced that the lacutamab IND has been placed on partial clinical hold by FDA following a recent patient death in the TELLOMAK study. The death of a patient affected by Sézary Syndrome was initially considered due to hemophagocytic lymphohistiocytosis (HLH), a rare hematologic disorder.

The FDA decision to lift the partial clinical hold is based on the FDA review of the fatal case which Innate, together with a steering committee of independent experts, determined to be related to aggressive disease progression and lacutamab unrelated.

“We have worked closely with the FDA to diligently resolve the partial clinical hold on the lacutamab IND, which included an in-depth analysis of the fatal case which was due to progression of an aggressive form of the disease.” said Dr Quaratino, Chief Medical Officer of Innate Pharma. “The lacutamab program continues to plan following the publication of the positive Sézary syndrome results at the recent ASH Annual Meeting 2023. We now look forward to sharing final data in Mycosis Fungoides.”