Regulatory Hurdle For Innate Pharma's Blood Cancer Studies

The FDA has placed a clinical hold on Innate Pharma SA's IPHA lacutamab Investigational New Drug (IND), leading to a pause in new patient enrollment in ongoing lacutamab trials IPH4102-201 (Phase 2 TELLOMAK) and 102 (Phase 1b PTCL). 

The partial clinical hold follows one fatal hemophagocytic lymphohistiocytosis (HLH), a rare hematologic (blood) disorder. 

Patients already on study treatment who are deriving clinical benefits 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 (n=170 patients). 

Enrollment is also completed in the initial cohort (n=20 patients) of the Phase 1b PTCL trial and is awaiting a futility interim analysis to progress to the next stage. 

Innate Pharma is on track for final data from the Phase 2 TELLOMAK trial and preliminary data on PTCL in Q4 2023.

"...Additionally, with all patients recruited into the Phase 2 TELLOMAK study, we do not currently anticipate any delay for the TELLOMAK Phase 2 final data due shortly," commented Mondher Mahjoubi, Chief Executive Officer of Innate Pharma. 

Price Action: IPHA shares are down 9.72% at $2.23 during the premarket session on the last check Thursday.