The Experimental Drug Development Center (EDDC), Singapore’s national platform for drug discovery and development, has announced the presentation of updated clinical data for the ongoing Phase I trial for EBC-129 at the 2025 Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago.
EBC-129 is a first-in-class antibody drug conjugate (ADC) targeting a novel, tumor-specific N256-glycosylated epitope on CEACAM5 and CEACAM6.
The updated findings showed promising efficacy data from 21 heavily pre-treated pancreatic ductal adenocarcinoma (PDAC) patients across the dose escalation and the dose expansion portions of the Phase I study.
Patients received EBC-129 at doses between 1.8 and 2.2 mg/kg, given once every three weeks. A total of 17 out of 21 patients (81%) had received prior treatment with taxanes; 82% of patients had tumors which expressed the EBC-129 antigen at ≥1% at 3+ intensity and were therefore considered treatable.
The overall response rates (ORRs) were 25% and 20%, with disease control rates (DCRs) of 87.5% and 63.6% and progression-free survival (PFS) of 19 and 12 weeks for 1.8 mg/kg and 2.2 mg/kg, respectively.
“Pancreatic adenocarcinoma remains one of the most challenging cancers to treat, particularly in the metastatic setting where resistance to standard therapies is common,” said Assistant Professor Robert W. Lentz, MD, Division of Medical Oncology, Department of Medicine, University of Colorado Anschutz School of Medicine.
“The clinical signals observed with EBC-129 in refractory pancreatic adenocarcinoma, including tolerability, prolonged disease control and a confirmed response in a heavily pre-treated patient, are encouraging and clinically meaningful. Continued prioritization of biology-guided trials targeting EBC-129 will be key to sustaining momentum in this important therapeutic effort.”
This presentation follows the recent Fast Track Designation granted by the U.S. FDA for EBC-129 in the treatment of PDAC patients. This designation supports EDDC’s efforts to accelerate the advancement of the program through increased regulatory engagement and the potential for expedited review pathways.
Other results to date
The dose escalation study of the Phase I trial was open to all patients, while the ongoing dose expansion study comprises of three cohorts in PDAC, gastroesophageal adenocarcinoma (GEA) and tumor-agnostic patients with other immunohistochemistry (IHC)-positive solid tumors. Recruitment for the GEA and IHC-positive cohorts is still ongoing.
EBC-129 showed a manageable safety profile in the 58 patients treated so far, with uncomplicated neutropenia and infusion-related reactions as the main treatment-related adverse events (TRAEs) observed.
The EBC-129 antigen was also found to be highly expressed, with 52% to 100% of tumor tissues assessed during the trial showing moderate to high expression levels of ≥20% at 2+ and/or 3+. This included samples from gastroesophageal, appendiceal, colorectal and lung cancer patients, making EBC-129 a potentially viable treatment option for these cancers.
“We have seen encouraging signs of efficacy of EBC-129 as a single-agent therapy, even in heavily pre-treated patients with metastatic pancreatic cancer,” said Professor Damian O’Connell, CEO of EDDC.
“This, combined with the observed safety profile, underscores the promise of EBC-129 as a possible treatment option for PDAC patients. As a first-in-class ADC that targets both CEACAM5 and CEACAM6, EBC-129 has also shown potential against a range of other solid tumors, and we look forward to expanding clinical evaluations with the ongoing dose expansion cohorts and accelerating the development of EBC-129 to address critical unmet needs in cancer.”
More information:
For information about the trial, please visit Clinicaltrial.gov, trial identifier NCT05701527.
Citation:
Updated data from Phase I study of antibody-drug conjugate EBC-129 released (2025, June 3)
retrieved 3 June 2025
from https://medicalxpress.com/news/2025-06-phase-antibody-drug-conjugate-ebc.html
This document is subject to copyright. Apart from any fair dealing for the purpose of private study or research, no
part may be reproduced without the written permission. The content is provided for information purposes only.
The Experimental Drug Development Center (EDDC), Singapore’s national platform for drug discovery and development, has announced the presentation of updated clinical data for the ongoing Phase I trial for EBC-129 at the 2025 Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago.
EBC-129 is a first-in-class antibody drug conjugate (ADC) targeting a novel, tumor-specific N256-glycosylated epitope on CEACAM5 and CEACAM6.
The updated findings showed promising efficacy data from 21 heavily pre-treated pancreatic ductal adenocarcinoma (PDAC) patients across the dose escalation and the dose expansion portions of the Phase I study.
Patients received EBC-129 at doses between 1.8 and 2.2 mg/kg, given once every three weeks. A total of 17 out of 21 patients (81%) had received prior treatment with taxanes; 82% of patients had tumors which expressed the EBC-129 antigen at ≥1% at 3+ intensity and were therefore considered treatable.
The overall response rates (ORRs) were 25% and 20%, with disease control rates (DCRs) of 87.5% and 63.6% and progression-free survival (PFS) of 19 and 12 weeks for 1.8 mg/kg and 2.2 mg/kg, respectively.
“Pancreatic adenocarcinoma remains one of the most challenging cancers to treat, particularly in the metastatic setting where resistance to standard therapies is common,” said Assistant Professor Robert W. Lentz, MD, Division of Medical Oncology, Department of Medicine, University of Colorado Anschutz School of Medicine.
“The clinical signals observed with EBC-129 in refractory pancreatic adenocarcinoma, including tolerability, prolonged disease control and a confirmed response in a heavily pre-treated patient, are encouraging and clinically meaningful. Continued prioritization of biology-guided trials targeting EBC-129 will be key to sustaining momentum in this important therapeutic effort.”
This presentation follows the recent Fast Track Designation granted by the U.S. FDA for EBC-129 in the treatment of PDAC patients. This designation supports EDDC’s efforts to accelerate the advancement of the program through increased regulatory engagement and the potential for expedited review pathways.
Other results to date
The dose escalation study of the Phase I trial was open to all patients, while the ongoing dose expansion study comprises of three cohorts in PDAC, gastroesophageal adenocarcinoma (GEA) and tumor-agnostic patients with other immunohistochemistry (IHC)-positive solid tumors. Recruitment for the GEA and IHC-positive cohorts is still ongoing.
EBC-129 showed a manageable safety profile in the 58 patients treated so far, with uncomplicated neutropenia and infusion-related reactions as the main treatment-related adverse events (TRAEs) observed.
The EBC-129 antigen was also found to be highly expressed, with 52% to 100% of tumor tissues assessed during the trial showing moderate to high expression levels of ≥20% at 2+ and/or 3+. This included samples from gastroesophageal, appendiceal, colorectal and lung cancer patients, making EBC-129 a potentially viable treatment option for these cancers.
“We have seen encouraging signs of efficacy of EBC-129 as a single-agent therapy, even in heavily pre-treated patients with metastatic pancreatic cancer,” said Professor Damian O’Connell, CEO of EDDC.
“This, combined with the observed safety profile, underscores the promise of EBC-129 as a possible treatment option for PDAC patients. As a first-in-class ADC that targets both CEACAM5 and CEACAM6, EBC-129 has also shown potential against a range of other solid tumors, and we look forward to expanding clinical evaluations with the ongoing dose expansion cohorts and accelerating the development of EBC-129 to address critical unmet needs in cancer.”
More information:
For information about the trial, please visit Clinicaltrial.gov, trial identifier NCT05701527.
Citation:
Updated data from Phase I study of antibody-drug conjugate EBC-129 released (2025, June 3)
retrieved 3 June 2025
from https://medicalxpress.com/news/2025-06-phase-antibody-drug-conjugate-ebc.html
This document is subject to copyright. Apart from any fair dealing for the purpose of private study or research, no
part may be reproduced without the written permission. The content is provided for information purposes only.
