28 May 2025: Experimental Drug Development Centre granted U.S. FDA Fast Track Designation for Antibody-Drug Conjugate EBC-129 to treat pancreatic ductal adenocarcinoma
EBC-129 is the first Singapore-made antibody-drug conjugate (ADC) in clinical development, targeting tumour-specific N-glycosylated epitopes on CEACAM5 and CEACAM6
The U.S. FDA granted Fast Track Designation to EBC-129 for treating pancreatic ductal adenocarcinoma (PDAC), aiming to expedite its development
EBC-129 is in Phase 1 trials for advanced solid tumours, tested alone and with pembrolizumab; enrolment for the PDAC group is complete
The ADC uses monomethyl auristatin E (MMAE) as its payload, known for synergy with PD-1 inhibitors and proven clinical use
Updated trial results will be presented at the 2025 ASCO Annual Meeting in Chicago