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US FDA grants fast track designation to EDDC’s antibody-drug conjugate EBC-129 to treat pancreatic ductal adenocarcinoma

30 May 2025
Admin
News Article

US FDA grants fast track designation to EDDC’s antibody-drug conjugate EBC-129 to treat pancreatic ductal adenocarcinoma

The Experimental Drug Development Centre (EDDC), Singapore’s national platform for drug discovery and development, announced that the US Food and Drug Administration (FDA) has granted Fast Track Designation for EBC-129. This designation is for the treatment of pancreatic ductal adenocarcinoma (PDAC).

EBC-129 is a first-in-class antibody drug conjugate (ADC) that targets a novel, tumour-specific N256-glycosylated epitope on CEACAM5 and CEACAM6. It is currently in Phase 1 clinical trials for patients with solid tumours with high unmet medical need.

Benefits of Fast Track Designation

The Fast Track Designation will allow:

Expedited development through more frequent interactions with the FDA
Potential eligibility for Priority Review and Accelerated Approval
Rolling review of future Biologic License Applications (BLA)

Professor Damian O’Connell, chief executive officer of EDDC, stated that this designation highlights the promise of EBC-129 in meeting the critical need for new treatments in PDAC and underscores EDDC’s responsibility to advance the drug swiftly for patient benefit.

Upcoming Clinical Data Presentation at ASCO 2025

Updated data from the ongoing Phase 1 trial of EBC-129 will be shared at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting.

Presentation Details

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
Session: Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary (Rapid Oral Session)
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, University of Colorado Anschutz School of Medicine

About EBC-129

EBC-129 is designed to target the N256-glycosylation site on CEACAM5 and CEACAM6, which are known to play roles in tumour formation, metastasis, and migration.

Tumour Targeting and Payload

The target marker is widely expressed across several solid tumour types including gastric, oesophageal, pancreatic, lung, colorectal, and appendiceal cancers.
An analytically validated immunohistochemistry (IHC) assay is used for detection.
The payload used is monomethyl auristatin E (MMAE), which is already approved in other ADCs and has shown synergy with PD-1 inhibitors.

Clinical Trial Design

The ongoing Phase 1 trial evaluates EBC-129:

As a monotherapy
In combination with pembrolizumab

The PDAC cohort has completed enrolment. Recruitment continues for the gastroesophageal adenocarcinoma (GEA) and IHC-positive cohorts.

About the Experimental Drug Development Centre (EDDC)

EDDC is Singapore’s national drug discovery and development platform. It was formed in 2019 through the integration of the Experimental Therapeutics Centre (ETC), Drug Discovery and Development (D3), and Experimental Biotherapeutics Centre (EBC).

Hosted by the Agency for Science, Technology and Research (A*STAR), EDDC works with both public and industry partners to translate biomedical research into innovative healthcare solutions for patients in Singapore, Asia, and beyond.