China-based RemeGen Ltd announced that its antibody drug conjugate (ADC) drug candidate RC118 has obtained two orphan drug designations (ODD) from the US FDA, for the therapy’s potential use against gastric and pancreatic cancers.
RC118: Mechanism and Development
RC118, a novel ADC drug candidate co-developed with contract research organization (CRO) Biocytogen, is conjugated with the Claudin 18.2 monoclonal antibody (mAb) and the small molecule microtubule inhibitor monomethyl auristatin (MMAE). The drug is subject to a Phase I study in locally advanced unresectable or metastatic malignant solid tumors in patients with positive CLDN18.2 expression, and is undergoing a dosage ascending study, having shown a good safety and tolerability profile.-Fineline Info & Tech
