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Immutep announced a focused development strategy for its lead candidate eftilagimod alfa following the early…
PRRUFIMMUTEP Ltd
Immutep announced a focused development strategy for its lead candidate eftilagimod alfa following the early discontinuation of the TACTI-004 study. A root cause analysis identified structural differences, specifically in N-glycan structure, between the drug manufactured at 2,000 L scale used in TACTI-004 and the 200 L scale used in prior successful trials. The company has contracted a new manufacturing run at 200 L scale to address these discrepancies. Future registration-directed development will target head and neck squamous cell carcinoma (HNSCC) in patients with CPS < 1, where efti holds Fast Track designation, and the neoadjuvant setting of soft tissue sarcoma (STS), which received Orphan Drug Designation in April 2026. Preparations for new clinical trials have commenced, with a study start targeted for the second half of calendar year 2027. Immutep is a clinical-stage biotechnology company developing novel immunotherapies for cancer and autoimmune diseases.