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# Experimental Pancreatic Cancer Drug Gets Fast Track
- URL: https://www.fdaweb.com/experimental-pancreatic-cancer-drug-gets-fast-track/
- Published: 2025-05-29T12:00:00.000Z
- Updated: 2026-09-14T15:12:59.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159271

FDA has granted the Experimental Drug Development Center a fast-track designation for EBC-129 and its use for treating pancreatic ductal adenocarcinoma. EBC-129 is described as a first-in-class antibody drug conjugate (ADC) targeting a novel, tumor-specific N256-glycosylated epitope on the CEACAM5 and CEACAM6 proteins. It is currently undergoing Phase 1 clinical trials for treating patients with solid tumors with high unmet medical need.

In the ongoing trial, the tumor-specific marker is found to be widely expressed in multiple solid tumor types, based on an analytically validated immunohistochemistry 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 Center says.