OBI Pharma announced on December 5 that its TROP2-targeted Antibody-Drug Conjugate (ADC), OBI-902, has been granted Orphan Drug Designation (ODD) by the U.S. FDA for the treatment of Gastric Cancer (GC), including Gastroesophageal Junction Cancer (GEJC).

Technical and Regulatory Details:

• Platform Technology: OBI-902 is the first ADC developed using the company's proprietary GlycOBI site-specific conjugation technology. It is currently undergoing concurrent Phase I/II clinical trials in both the U.S. and Taiwan.
• Benefits of ODD: This designation provides OBI Pharma with tax credits for clinical trials, waiver of prescription drug user fees (PDUFA), and seven years of market exclusivity upon approval.
• Unmet Needs: CEO Heidi Wang noted that following its previous ODD for Cholangiocarcinoma (bile duct cancer), this second designation for gastric cancer validates the clinical potential of the GlycOBI platform and enhances the drug's value for international strategic partnerships.

Resource: 浩鼎OBI-902再獲FDA孤兒藥資格認定，適應症擴及胃癌