Innate Pharma Provides Update from Regulatory Agencies on Lacutamab TELLOMAK Trial
Innate Pharma S.A. - American Depositary Shares (IPHA)
Company Research
Source: GlobeNewswire
MARSEILLE, France, Jan. 09, 2020 (GLOBE NEWSWIRE) -- Innate Pharma SA (Euronext Paris: IPH – ISIN: FR0010331421; Nasdaq: IPHA) (“Innate” or the “Company”) today announced a regulatory update regarding its TELLOMAK Phase II trial, evaluating the efficacy and safety of lacutamab (IPH4102) in patients with advanced T-cell lymphomas. The Company has been in ongoing discussions with regulatory authorities regarding Good Manufacturing Practice (GMP) deficiencies at the Company’s manufacturing subcontractor site that manages the fill and finish operations of the lacutamab clinical vials. Based on these discussions, on December 13, 2019, the Company decided to suspend enrollment of new patients in the TELLOMAK trial, except in Italy where the clinical trial has been suspended. The Company has received the following new regulatory feedback: The US Food and Drug Administration (FDA) has placed the TELLOMAK trial on partial clinical hold. Currently enrolled patients can continue treatment in
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