Arbele, a Hong Kong-based biotechnology company focused on developing innovative targeted cancer therapies, announced on Wednesday that it has received Orphan Drug Designation (ODD) from the US Food and Drug Administration (FDA) for ARB1002, its investigational antibody-drug conjugate (ADC) for the treatment of pancreatic cancer.

ARB1002 is composed of an anti-CDH17 monoclonal antibody chemically linked to a potent cytotoxic agent. The ADC is designed to selectively bind CDH17, a cell-surface adhesion molecule overexpressed in pancreatic cancer, enabling targeted delivery of the cytotoxic payload to tumour cells while limiting off-target exposure.

ARB1002 is planned to enter a Phase 1 clinical trial this year, with Arbele completing IND-enabling studies to support its clinical assessment in pancreatic cancer.