Innate Pharma SA (Euronext Paris: IPH – ISIN: FR0010331421; Nasdaq: IPHA) (“Innate” or the “Company”) today announced that the French National Agency for Medicines and Health Product Safety (ANSM) has agreed that the lacutamab (IPH4102) TELLOMAK Phase II trial can resume recruitment of new patients with relapsed/refractory Sézary syndrome and mycosis fungoides (MF) who have received at least two lines of prior systemic therapy.
Following discussions with the Company, the ANSM decision to allow new patient recruitment to resume in Sézary syndrome and MF in France is based on an assessment of the unmet medical need and the lack of currently available standard of care options. Conversely, because standard of care options are available to patients with peripheral T-cell lymphoma (PTCL), no new patients can enroll in the trial until a new Good Manufacturing Practice (GMP)-certified batch is available. However, currently enrolled PTCL patients can continue treatment in the trial.
In light of this feedback, the Company will take the operational measures to reactivate the lacutamab TELLOMAK trial in Sézary syndrome and MF in France and UK, where regulatory agencies have authorized it.
“We are pleased that the ANSM agrees to resume enrollment of patients with Sézary syndrome and mycosis fungoides in the lacutamab TELLOMAK trial in France given the high medical need and lack of adequate treatment options currently available,” commented Pierre Dodion, MD, Executive Vice President and Chief Medical Officer of Innate Pharma. “Our utmost priority has been to ensure patient safety, and ANSM did not cite any safety concerns related to the trial medication.”
As a reminder, the Company has been in ongoing discussions with US and European national regulatory authorities regarding GMP deficiencies at the Company’s manufacturing subcontractor site that manages the fill and finish operations of the lacutamab clinical vials for the TELLOMAK trial. TELLOMAK has been on partial clinical hold globally since Dec. 13, 2019, except in Italy where the clinical trial has been suspended. On Jan. 9, 2020, the US Food and Drug Administration placed the TELLOMAK trial on partial clinical hold. The Company has not yet received feedback from regulatory authorities in Germany and Spain.