OBI Pharma’s OBI-999 Receives the US FDA’s Orphan Drug Designation for Pancreatic Cancer

OBI Pharma’s OBI-999 Receives the US FDA’s Orphan Drug Designation for Pancreatic Cancer

Shots:

  • OBI Pharma has initiated the enrollment of P-I/II study at the University of Texas M.D. Anderson Cancer Center to evaluate the therapy in patients with LA/m-solid tumors
  • The objective of the study is to assess the safety & preliminary efficacy profile of OBI-999 in patients with pancreatic, gastric, colorectal and esophageal cancers
  • OBI-999 is a first-in-class ADC targeting Globo H, a glycolipid antigen, utilizes validated IHC assay to select patients for P-II study. The ODD is granted to novel drugs and biologics which are intended for the safe and effective treatment, diagnosis or prevention of rare diseases affecting people less than 200,000 in the US

Click here to­ read full press release/ article | Ref: PRNewswire | Image: The Pharma Letter