U.S. Food and Drug Administration lifts partial clinical hold on lacutamab TELLOMAK trial in advanced T-cell lymphomas

Innate Pharma to re-activate TELLOMAK trial in the US

New GMP-certified batch has been successfully manufactured

Conference call to be held today on the lacutamab clinical trial program 

Innate Pharma SA (Euronext Paris: IPH – ISIN: FR0010331421; Nasdaq: IPHA) (“Innate” or the “Company”) today announced that the U.S. Food and Drug Administration (FDA) has lifted the partial clinical hold placed on the lacutamab TELLOMAK Phase II clinical trial, evaluating the efficacy and safety of lacutamab (formerly IPH4102) in patients with advanced T-cell lymphomas. 

The FDA decision is based on a quality assessment of a new Good Manufacturing Practice (GMP)-certified batch that has been successfully manufactured for the lacutamab clinical development program, including the TELLOMAK trial. The Company can now resume recruitment of new patients in the US with relapsed/refractory Sézary syndrome and mycosis fungoides (MF) who have received at least two prior systemic therapies.  

In light of the FDA feedback, the Company is taking the operational measures to re-activate the US clinical trial sites. 

“We are pleased that the FDA has approved the new clinical batch for the TELLOMAK trial, and we can resume enrollment of patients with Sézary syndrome and mycosis fungoides given the importance of novel and effective treatment options needed for these patient populations,” commented Pierre Dodion, MD, Executive Vice President and Chief Medical Officer of Innate Pharma. “We’re confident in our ability to supply lacutamab in this important trial moving forward, and look forward to reactivating the trial globally as quickly as possible.”

As a reminder, the FDA placed the TELLOMAK trial on partial hold due to GMP deficiencies at the Company’s manufacturing subcontractor site that managed the fill and finish operations of the lacutamab clinical vials for TELLOMAK. In Europe, the national regulatory authorities in Spain, Italy and Germany temporarily halted the trial whereas the French and UK regulatory authorities agreed to resume trial recruitment in those respective countries earlier this year.  The Company is consulting the regulatory authorities in Germany, Italy and Spain in order to resume the trial in these countries soon.