#Singapore #pancreatic cancer #ASCO 2025 #EBC-129

Introduction

The Experimental Drug Development Centre (EDDC) has unveiled updated results from the Phase 1 study of EBC-129, a novel antibody-drug conjugate (ADC), during the 2025 Annual Meeting of the American Society of Clinical Oncology (ASCO) held in Chicago. This updated clinical data is especially notable as EBC-129 represents a groundbreaking approach in targeting pancreatic ductal adenocarcinoma (PDAC), a notoriously difficult cancer to treat due to its aggressive nature and past resistance to standard therapies.

About EBC-129

EBC-129 specifically targets a unique and tumor-specific N-glycosylated epitope found on CEACAM5 and CEACAM6, proteins significant in cancer progression and metastasis. The significance of this targeting lies in its precision; by focusing on these specific markers, EBC-129 aims to minimize effects on healthy cells while treating malignant ones. Recent results indicate that 82% of patients in the study displayed tumors that expressed the targeted antigens at levels that allowed for treatment with the ADC.

Clinical Trial Insights

The ongoing Phase 1 trial is structured into two parts: dose escalation and expansion. In the latest cohort, 21 patients with heavily pre-treated PDAC received EBC-129 at doses ranging from 1.8 to 2.2 mg/kg, administered every three weeks. Notably, a vast majority (81%) of these patients had previously undergone treatment involving taxanes, standard chemotherapeutic agents, reflecting the challenge faced in managing such resilient cases.

The clinical data reveals an overall response rate (ORR) of 25% and 20% in the test cohort, alongside significant disease control rates (DCRs) of 87.5% and 63.6% for the respective doses. Furthermore, progression-free survival (PFS) figures were reported at 19 weeks for the lower dose and 12 weeks for the higher dose, indicating that EBC-129 may extend the time before the disease worsens, providing patients with a valuable window of improved health.

Significance of FDA Designation

Adding to the optimism surrounding EBC-129, the U.S. FDA has granted Fast Track Designation for this ADC in treating PDAC. This designation entails expedited regulatory engagement, allowing the EDDC to potentially fast-track the drug's development and availability for patients in need, thus addressing a critical gap in cancer therapies.

Safety and Additional Results

Among the 58 participants already treated in the trial, EBC-129 exhibited a manageable safety profile. The most common treatment-related adverse events were readily addressable, including uncomplicated neutropenia and mild infusion reactions. An important finding during the trial is the high expression levels of the EBC-129 antigen across various tumor types—gastroesophageal, colorectal, and lung cancers—indicating the ADC's applicability beyond PDAC.

Future Directions

The EDDC's ongoing work with EBC-129 includes expanding clinical evaluations into the GEA and other solid tumors with IHC-positive expression. Enthusiasm persists among researchers, as highlighted by Assistant Professor Robert W. Lentz and EDDC’s CEO, Professor Damian O'Connell, stressing the importance of the ongoing trials in identifying responses in resistant cancer types.

In conclusion, EBC-129 presents a compelling avenue for improving treatment outcomes in patients facing dire prognoses due to pancreatic cancer. The results shared at ASCO 2025 not only highlight the drug's potential effectiveness but also pave the way for continued innovation in cancer treatment strategies.