On May 28, 2025 The Experimental Drug Development Centre (EDDC), Singapore’s national platform for drug discovery and development, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for EBC-129 for the treatment of pancreatic ductal adenocarcinoma (PDAC) (Press release, Experimental Drug Development Centre, MAY 28, 2025, View Source [SID1234654012]). EBC-129 is a first-in-class antibody drug conjugate (ADC) targeting a novel, tumour-specific N256-glycosylated epitope on CEACAM5 and CEACAM6. It is currently undergoing Phase 1 clinical trials for the treatment of patients with solid tumours with high unmet medical need.
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The Fast Track Designation facilitates the expedited development of EBC-129, enabling more frequent engagement with the FDA to discuss the clinical development plan. It also provides potential eligibility for Priority Review and Accelerated Approval, as well as rolling review of any future Biologic License Application (BLA).
"The FDA’s Fast Track Designation for EBC-129 underscores the promise of this novel ADC in addressing the critical need for expanded treatment options for PDAC patients and represents an important step in our efforts to accelerate its development. We view this as both a validation of our efforts and a responsibility to move decisively to advance EBC-129 as a new option to patients in need," said Professor Damian O’Connell, Chief Executive Officer of EDDC.
Updated clinical data from the ongoing Phase 1 study of EBC-129 will be presented at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place in Chicago from 30 May to 3 June 2025.
Presentation Details at ASCO (Free ASCO Whitepaper) 2025:
Title: Clinical activity of EBC-129, a first-in class, anti-N256-glycosylated CEACAM5 and CEACAM6 antibody-drug conjugate (ADC), in patients with pancreatic ductal adenocarcinoma (PDAC) in a Phase 1 study
Rapid Oral Session Title: Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary
Date and Time: Monday, June 2, 2025, 11:30 AM – 1:00 PM GMT-5
Abstract Number: 4018
Presenter: Assistant Professor Robert W. Lentz, MD, Division of Medical Oncology, Department of Medicine, University of Colorado Anschutz School of Medicine
About EBC-129
EBC-129 is an ADC that targets a tumour-specific N256-glycosylation site conserved on CEACAM5 and CEACAM6. CEACAM5 and CEACAM6 are known to have functional importance in tumour formation, migration and metastasis. In the ongoing trial, the tumour-specific marker is found to be widely expressed in multiple solid tumour types, including gastric, oesophageal, pancreatic, lung, colorectal, and appendiceal cancers, based on an analytically validated immunohistochemistry (IHC) assay. The payload used in EBC-129 is monomethyl auristatin E (MMAE) which has been extensively tested and approved for clinical use in other marketed ADCs and has demonstrated synergy with PD-1 inhibitors. The ongoing Phase 1 trial of EBC-129 is assessing the safety and tolerability of EBC-129 as a single agent and in combination with pembrolizumab in patients with advanced solid tumours. Enrolment for the PDAC cohort in the Phase 1 dose expansion study is now complete, while recruitment continues for the gastroesophageal adenocarcinoma (GEA) and IHC-positive cohorts.