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 made-in-Singapore antibody-drug conjugate (ADC) to enter clinical development. It selectively targets a tumour-specific N-glycosylated epitope on both CEACAM5 and CEACAM6. 
• The Fast Track Designation highlights the potential of EBC-129 to address critical unmet needs in pancreatic ductal adenocarcinoma (PDAC).
• Updated clinical data from the ongoing Phase 1 study of EBC-129 will be presented at the 2025 Annual Meeting of the American Society of Clinical Oncology (ASCO).

SINGAPORE, May 28, 2025 /CNW/ -- The Experimental Drug Development Centre (EDDC), Singapore's national platform for drug discovery and development, today announced 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). 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.

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) Annual Meeting, taking place in Chicago from 30 May to 3 June 2025.

Presentation Details at ASCO 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.

For information about the trial, please visit Clinicaltrial.gov, trial identifier NCT05701527. 

About the Experimental Drug Development Centre 

The Experimental Drug Development Centre (EDDC) is Singapore's national platform for drug discovery and development, formed from the integration of the Experimental Therapeutics Centre (ETC), Drug Discovery and Development (D3), and Experimental Biotherapeutics Centre (EBC) in 2019. EDDC aims to develop therapeutics and diagnostics that save and improve the lives of patients in Singapore, Asia and around the world. Hosted by the Agency for Science, Technology and Research (A*STAR), EDDC works collaboratively with public sector and industry partners to translate the great science arising from Singapore's biomedical and clinical sciences R&D into innovative healthcare solutions. For more information about EDDC, please visit www.eddc.sg.   

SOURCE EXPERIMENTAL DRUG DEVELOPMENT CENTRE

Media Contact: Agency for Science, Technology and Research (A*STAR), Aileen Tan, [email protected]; Lydia Sum, [email protected]