U.S. Food and Drug Administration (FDA) grants rapid development approval to the Experimental Drug Centre for their Antibody-Drug Conjugate, EBC-129, aimed at combatting Pancreatic Ductal Adenocarcinoma.

U.S. Food and Drug Administration (FDA) grants rapid development approval to the Experimental Drug Centre for their Antibody-Drug Conjugate, EBC-129, aimed at combatting Pancreatic Ductal Adenocarcinoma.

Singapore's Experimental Drug Development Centre (EDDC) announced on May 28th that the U.S. Food and Drug Administration (FDA) has granted the Fast Track Designation for EBC-129, a first-in-class antibody-drug conjugate (ADC) targeting pancreatic ductal adenocarcinoma (PDAC). This designation will expedite the development and potential approval process for EBC-129, which selectively targets a tumor-specific N-glycosylated epitope on CEACAM5 and CEACAM6.

EBC-129 is currently in its Phase 1 clinical trials, evaluating its safety and efficacy in patients with advanced solid tumors, including PDAC. The ongoing trial assesses the compound as a single agent and in combination with pembrolizumab (Keytruda). Enrollment for the PDAC cohort in the phase 1 trial has been completed, indicating significant progress in its clinical development.

The FDA's Fast Track Designation provides potential eligibility for Priority Review, Accelerated Approval, and rolling review of any future Biologic License Application (BLA). This designation underscores the promise of EBC-129 in addressing the critical need for expanded treatment options for PDAC patients.

Professor Damian O'Connell, Chief Executive Officer of EDDC, stated, "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."

Updated clinical data from the phase 1 study 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. The presentation is titled "Clinical activity of EBC-129 in patients with pancreatic ductal adenocarcinoma (PDAC) in a Phase 1 study."

In addition to the presentation at the ASCO meeting, the FDA's decision highlights EBC-129's potential to address unmet medical needs in PDAC. The fast track designation and ongoing clinical trials could pave the way for EBC-129's potential approval and availability as a treatment option for PDAC patients.

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

References:[1] PR Newswire. (2025, May 28). Experimental Drug Development Centre granted US FDA Fast Track Designation for antibody-drug conjugate EBC-129 to treat pancreatic ductal adenocarcinoma. https://www.prnewswire.com/news-releases/experimental-drug-development-centre-granted-us-fda-fast-track-designation-for-antibody-drug-conjugate-ebc-129-to-treat-pancreatic-ductal-adenocarcinoma-302465707.html[2] U.S. Food and Drug Administration. (n.d.). Fast Track. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fast-track[3] Pembrolizumab (Keytruda) (n.d.). Mayo Clinic. https://www.mayoclinic.org/drugs-supplements/pembrolizumab-keytruda/description/drg-20071874[4] U.S. Food and Drug Administration. (n.d.). Priority Review and Accelerated Approval. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/priority-review[5] Biologics License Application (BLA) (n.d.). U.S. Food and Drug Administration. https://www.fda.gov/drugs/development-approval-process/biologics-license-application-bla-process-cber

1. The Fast Track Designation granted by the FDA for EBC-129 signifies its potential to speed up the development and approval process for this medical-condition treatment, particularly for patients with pancreatic ductal adenocarcinoma (PDAC), as it could pave the way for its availability in the health-and-wellness sector.
2. Professor Damian O'Connell, the CEO of EDDC, commented on the Fast Track Designation, stating it as both a validation of their hard work and a responsibility to expedite the advancement of EBC-129 as a new treatment option for patients in need.
3. The cloud of uncertainty surrounding PDAC treatment may begin to clear as updates from the ongoing clinical trials of EBC-129 point towards potential news about this first-in-class antibody-drug conjugate (ADC), especially with its ability to selectively target tumors with CEACAM5 and CEACAM6, as highlighted in the latest science research.

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