Phase 1 trial for EBC-129 progresses into dose expansion

The Experimental Drug Development Centre (EDDC), Singapore's national platform for drug discovery and development, is pleased to announce that the Phase 1 trial for EBC-129 has progressed into dose expansion. 

EBC-129 is the first made-in-Singapore ADC to enter clinical development. The tumor antigen it targets is a specific N-glycosylated site conserved on both CEACAM 5 and 6 which is selectively expressed on cancer cells, over normal cells. This allows EBC-129 to address a broad range of solid cancers expressing either one or both tumor markers, including cancers prevalent in Asia like gastroesophageal and lung cancers, as well as cancers with very limited treatment options like pancreatic cancer and cholangiocarcinoma.

The Phase 1 trial began with a dose escalation study which evaluated the safety and tolerability of EBC-129 in patients with unresectable metastatic solid tumors. The first patient for the dose escalation was dosed at the National Cancer Centre Singapore (NCCS) in May 2023. EBC-129 is also being tested at the National University Cancer Institute, Singapore (NCIS), as well as the MD Anderson Cancer Center and the University of Colorado Cancer Center in the United States. The dose escalation study showed that EBC-129 is well-tolerated by cancer patients. Tumor shrinkage by ≥30% was observed in an oesophageal cancer patient as well as a pancreatic cancer patient.

The Phase 1 trial has now progressed into dose expansion, with the first patient for this part of the study dosed on 13^th May 2024. The dose expansion study comprises three groups of 15 patients each with gastroesophageal cancers, pancreatic ductal adenocarcinomas, and solid tumours expressing the tumour antigen at moderate or high levels.

The ADC and the immunohistochemistry (IHC)-based test used for patient selection were developed collaboratively by NCCS, A*STAR's Bioprocessing Technology Institute (BTI) and the Institute for Molecular and Cell Biology (IMCB), as well as EDDC.

Our team at NCCS has been very encouraged by the progress of this ongoing trial for EBC-129 which has shown good tolerability and early signs of efficacy in the dose escalation study. We have strong patient interest for participation in the dose expansion study and look forward to the development of EBC-129 as a potential treatment for cancer patients in the future."

Matthew Ng, Clinical Assistant Professor, Head, Department of Gastrointestinal and Neurological Medical Oncology, NCCS

"I am excited to delve deeper into EBC-129's promise as a therapeutic option for pancreatic and gastroesophageal cancers through the dose expansion study. The demand for safe and effective treatments in these cancer types remains substantial, and we are dedicated to addressing these unmet needs," said Dr Yong Wei Peng, Senior Consultant, Department of Haematology-Oncology, NCIS.

 "We are thrilled by the positive developments we have seen in the dose escalation study, and grateful for all our collaborators as well as the team at EDDC, who have been instrumental for us to reach this milestone", said Prof Damian O'Connell, EDDC's Chief Executive Officer. "We will continue to work with our clinical partners to progress the dose expansion study and advance the potential of EBC-129 as an effective, targeted therapy for cancer patients."