The U.S. Food and Drug Administration has granted Fast Track Designation to EBC-129, a novel antibody-drug conjugate developed by Singapore's Experimental Drug Development Centre (EDDC) for the treatment of pancreatic ductal adenocarcinoma (PDAC). This milestone marks the first made-in-Singapore ADC to enter clinical development and highlights the therapeutic potential for addressing critical unmet needs in one of the most challenging cancer types.
Novel Targeting Mechanism
EBC-129 represents a first-in-class antibody drug conjugate that targets a novel, tumor-specific N256-glycosylated epitope on CEACAM5 and CEACAM6 proteins. These carcinoembryonic antigen-related cell adhesion molecules are known to have functional importance in tumor formation, migration and metastasis. The tumor-specific marker has been found to be widely expressed in multiple solid tumor types, including gastric, esophageal, pancreatic, lung, colorectal, and appendiceal cancers, based on an analytically validated immunohistochemistry assay.
The ADC utilizes monomethyl auristatin E (MMAE) as its cytotoxic payload, which has been extensively tested and approved for clinical use in other marketed ADCs. Notably, MMAE has demonstrated synergy with PD-1 inhibitors, potentially expanding combination therapy options.
Regulatory Advantages
The Fast Track Designation provides several strategic advantages for EBC-129's development pathway. It enables more frequent engagement with the FDA to discuss the clinical development plan and provides potential eligibility for Priority Review and Accelerated Approval. Additionally, the designation allows for rolling review of any future Biologic License Application (BLA), potentially accelerating the path to market approval.
"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," said Professor Damian O'Connell, Chief Executive Officer of EDDC. "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."
Clinical Development Progress
EBC-129 is currently undergoing Phase 1 clinical trials assessing the safety and tolerability of the ADC as a single agent and in combination with pembrolizumab in patients with advanced solid tumors. The trial is registered under identifier NCT05701527 on ClinicalTrials.gov.
Enrollment for the PDAC cohort in the Phase 1 dose expansion study has been completed, while recruitment continues for the gastroesophageal adenocarcinoma and IHC-positive cohorts. Updated clinical data from the ongoing Phase 1 study will be presented at the 2025 American Society of Clinical Oncology Annual Meeting.
ASCO 2025 Presentation
The clinical findings will be presented during a Rapid Oral Session focused on Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary on Monday, June 2, 2025, from 11:30 AM to 1:00 PM GMT-5. Assistant Professor Robert W. Lentz from the Division of Medical Oncology at the University of Colorado Anschutz School of Medicine will present the data under abstract number 4018.
The presentation, titled "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," will provide updated insights into the therapeutic potential of this novel approach.
Singapore's Drug Development Platform
EDDC serves as Singapore's national platform for drug discovery and development, formed from the integration of the Experimental Therapeutics Centre, Drug Discovery and Development, and Experimental Biotherapeutics Centre in 2019. Hosted by the Agency for Science, Technology and Research (A*STAR), EDDC collaborates with public sector and industry partners to translate biomedical and clinical sciences research into innovative healthcare solutions for patients in Singapore, Asia, and globally.
