CanariaBio Achieves Significant Milestone with FDA's Orphan Drug Designation for MAb-AR20.5 Targeting Pancreatic Cancer
PYEONGTAEK, South Korea, Aug. 21, 2023 /PRNewswire/ -- CanariaBio Inc., a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative immunotherapies for cancer, announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to its investigational drug product, MAb-AR20.5, an IgG1k type murine monoclonal antibody that binds specifically to the circulating and tumor-associated antigen (MUC1) expressed ubiquitously on pancreatic cancer cells. This milestone marks the first monoclonal antibody targeting Mucin 1 (MUC1) to receive this designation for pancreatic cancer.