Immutep (ASX:IMM) has announced the regulatory authorisation of eftilagimod alpha (efti) manufactured at commercial 2,000L scale for clinical trials across multiple countries, including Germany, Belgium, Denmark, and the UK.
The company said that after successfully scaling up the manufacturing process of efti to commercial scale at WuXi Biologics, the process-related changes were presented in a substantial amendment of the Investigational Medicinal Product Dossier (IMPD).
It said overall comparability of the first 2,000L and the previous 200L scale clinical-stage manufacturing process was achieved.
CEO Marc Voigt said, “With late-stage clinical development underway for our first-in-class soluble LAG-3 protein and MHC Class II agonist in non-small cell lung cancer, head and neck cancer, and metastatic breast cancer, commercial scale manufacturing of efti for use in clinical trials is a significant achievement and brings us closer to realizing efti’s potential to help cancer patients worldwide."