Just – Evotec Biologics, Inc., the biologics segment of Evotec SE, announced today that cGMP clinical materials manufactured for FibroGen were cleared for clinical use by the United States Food and Drug Administration (“FDA”) as part of FibroGen’s Investigational New Drug (“IND”) filing. FibroGen aims to begin enrollment of their Phase I clinical trial evaluating the safety and efficacy of FG-3165 in patients with solid tumors characterized by high Gal9 levels of expression in the second half of 2024. Their proprietary FG-3165, a galectin-9 (“Gal9”) targeted monoclonal antibody (“mAb”) is under development for the treatment of solid tumors.
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