OBI Pharma Granted FDA Orphan Drug Designation for OBI-888 for the Treatment of Pancreatic Cancer
OBI Pharma, Inc., a Taiwan biopharma company announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for OBI-888 for the treatment of Pancreatic Cancer. OBI-888 is a first in class monoclonal antibody cancer immunotherapy targeting Globo H, a glycolipid antigen.
A Phase 1 study of OBI-888 has commenced enrollment at the University of Texas M.D. Anderson Cancer Center in patients with locally advanced or metastatic solid tumors, potentially including Pancreatic, Breast, Gastric, Esophageal, Colorectal and Lung Cancers.
Amy Huang, General Manager of OBI Pharma, noted, “The orphan drug designation for OBI-888 by the FDA is encouraging and is a significant step in the development of this novel monoclonal antibody drug candidate targeting Globo H. In addition to targeting other solid tumors, OBI-888 will be evaluated for the treatment of pancreatic cancer, a disease with very limited treatment options. OBI will continue our utmost efforts to develop innovative therapies for people living with cancer.”