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FDA Places Partial Clinical Hold on IND for Lacutamab in CTCL/PTCL

The FDA has placed a partial clinical hold on investigational new drug application for lacutamab, leading to a pause in new patient enrollment for the phase 2 TELLOMAK trial and a phase 1b trial, which are evaluating the agent in patients with advanced cutaneous T-cell lymphoma and peripheral T-cell lymphoma, respectively.

FDA places partial hold on trials for T-cell lymphomas after patient death

Innate Pharma Provides Update on Lacutamab Clinical Program

MARSEILLE, France, October 05, 2023 Regulatory News: Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company") today announced that the U.S. Food and Drug Administration (FDA) has placed a partial clinical hold on the lacutamab IND leading 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

Innate Pharma SA: Innate Pharma Provides Update on Lacutamab Clinical Program

Innate Pharma Provides Update on Lacutamab Clinical Program - Innate Pharma (NASDAQ:IPHA)

Phase 2 TELLOMAK trial fully recruited, final data expected Q4 2023 Phase 1b PTCL trial awaiting futility interim analysis, preliminary data expected Q4 2023 US FDA places lacutamab IND on partial clinical hold