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FDA Grants Orphan Drug Status to OBI's Targeted Pancreatic Cancer Therapy

NEW YORK – OBI Pharma announced Thursday that the US Food and Drug Administration granted orphan drug designation to its investigational therapy OBI-999 for pancreatic cancer. 


OBI-999 is an antibody drug conjugate that targets a glycolipid antigen called Globo H, which is  expressed in up to 15 epithelial cancers.


"Many pancreas cancers highly overexpress Globo H, the glycolipid target of OBI-999," OBI CMO Tillman Pearce noted in a statement. 


In preclinical xenograft animal models of pancreatic, lung, gastric, and breast cancers, OBI-999 shrunk tumors significantly and appeared to be well-tolerated. 


A Phase I/II, first-in-human clinical trial of OBI-999 is now enrolling patients with locally advanced or metastatic solid tumors, including pancreatic, gastric, colorectal and esophageal cancers at the University of Texas MD Anderson Cancer Center to verify drug safety and preliminary efficacy. 


In Phase II, a validated immunohistochemistry assay will select patients whose cancers overexpress Globo H.