China’s Lepu Biopharma Co., Ltd (HKG: 2157) announced that the U.S. FDA has granted orphan drug designation (ODD) to its antibody-drug conjugate (ADC) MRG002 for gastric cancer and gastroesophageal junction adenocarcinoma (GC/GEJ). The drug is in a Phase I/II trial in the U.S. targeting HER2-positive, advanced or metastatic GC/GEJ.
Drug Profile
MRG002 combines MAB802, an antibody promoting fucosylation to reduce ADCC activity, with the microtubule inhibitor MMAE via a valine-citrulline linker. Preclinical data showed MRG002 outperformed T-DM1 in HER2+ gastric cancer models.
Clinical Development
In China, MRG002 has completed exploratory studies in multiple indications and is in a Phase II trial for HER2-positive/low-expressing GC/GEJ. The U.S. trial will evaluate dosing and efficacy in HER2+ patients.
Strategic Outlook
The ODD accelerates MRG002’s development, positioning Lepu to address unmet needs in HER2+ gastric cancer globally. The company plans to leverage the designation for potential regulatory benefits and expedited reviews.-Fineline Info & Tech
