SYDNEY, AUSTRALIA – April 17, 2024 – Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep” or “the Company”), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, today announces it has received positive feedback from the Spanish Agency for Medicines and Health Products (AEMPS) Competent Authority regarding the Company’s upcoming TACTI-004 Phase III trial of eftilagimod alpha (“efti”) for first line treatment of metastatic non-small cell lung cancer (1L NSCLC).
Immutep SVP, Regulatory & Strategy, Christian Mueller commented: “We continue to be pleased with our discussions with regulatory bodies around the world regarding our upcoming pivotal TACTI-004 trial and are thankful for the positive feedback and constructive guidance received by AEMPS. Spain, a member of the EMA’s Committee for Medicinal Products for Human Use (CHMP), represents an important region given the relatively large number of institutions that participated in our TACTI-002 Phase II study evaluating efti in combination with anti-PD-1 therapy in first line non-small cell lung cancer.”
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