Innate Pharma Says FDA Places Partial Clinical Hold On Lacutamab IND; Stock Down 10%
(RTTNews) - Innate Pharma SA (IPHA) announced Thursday that the U.S. Food and Drug Administration (FDA) has placed a partial clinical hold on the lacutamab IND. This has led to a pause in new patient enrollment to the Company's ongoing lacutamab trials IPH4102-201 (Phase 2 TELLOMAK) and 102 (Phase 1b PTCL).
The partial clinical hold follows one fatal case of hemophagocytic lymphohistiocytosis (HLH), a rare hematologic disorder. Patients already on study treatment who are deriving clinical benefit may continue treatment after being reconsented.
TELLOMAK, Innate Pharma's ongoing Phase 2 trial of lacutamab in cutaneous T-cell lymphoma (CTCL), completed enrollment in Q2 2023. Enrollment is also completed to the initial cohort of the Phase 1b PTCL trial.
Innate Pharma is on track for final data from the Phase 2 TELLOMAK trial and preliminary data on PTCL in Q4 2023.
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