Acute exudative pancreatitis on CT scan. Credit score: Hellerhoff/Wikipedia
The Experimental Drug Improvement Heart (EDDC), Singapore’s nationwide platform for drug discovery and growth, has introduced the presentation of up to date scientific knowledge for the continued Section I trial for EBC-129 on the 2025 Annual Assembly of the American Society of Medical Oncology (ASCO) in Chicago.
EBC-129 is a first-in-class antibody drug conjugate (ADC) focusing on a novel, tumor-specific N256-glycosylated epitope on CEACAM5 and CEACAM6.
The up to date findings confirmed promising efficacy knowledge from 21 closely pre-treated pancreatic ductal adenocarcinoma (PDAC) sufferers throughout the dose escalation and the dose enlargement parts of the Section I examine.
Sufferers obtained EBC-129 at doses between 1.8 and a couple of.2 mg/kg, given as soon as each three weeks. A complete of 17 out of 21 sufferers (81%) had obtained prior therapy with taxanes; 82% of sufferers had tumors which expressed the EBC-129 antigen at ≥1% at 3+ depth and had been due to this fact thought-about treatable.
The general response charges (ORRs) had been 25% and 20%, with illness management charges (DCRs) of 87.5% and 63.6% and progression-free survival (PFS) of 19 and 12 weeks for 1.8 mg/kg and a couple of.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,” mentioned Assistant Professor Robert W. Lentz, MD, Division of Medical Oncology, Division of Drugs, College of Colorado Anschutz College of Drugs.
“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 current Quick Monitor Designation granted by the U.S. FDA for EBC-129 within the therapy of PDAC sufferers. This designation helps EDDC’s efforts to speed up the development of this system by elevated regulatory engagement and the potential for expedited assessment pathways.
Different outcomes thus far
The dose escalation examine of the Section I trial was open to all sufferers, whereas the continued dose enlargement examine includes of three cohorts in PDAC, gastroesophageal adenocarcinoma (GEA) and tumor-agnostic sufferers with different immunohistochemistry (IHC)-positive stable tumors. Recruitment for the GEA and IHC-positive cohorts remains to be ongoing.
EBC-129 confirmed a manageable security profile within the 58 sufferers handled thus far, with uncomplicated neutropenia and infusion-related reactions as the primary treatment-related hostile occasions (TRAEs) noticed.
The EBC-129 antigen was additionally discovered to be extremely expressed, with 52% to 100% of tumor tissues assessed in the course of the trial displaying reasonable to excessive expression ranges of ≥20% at 2+ and/or 3+. This included samples from gastroesophageal, appendiceal, colorectal and lung most cancers sufferers, making EBC-129 a probably viable therapy choice 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,” mentioned 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.”
Extra info:
For details about the trial, please go to Clinicaltrial.gov, trial identifier NCT05701527.
Supplied by
Company for Science, Expertise and Analysis (A*STAR), Singapore
Quotation:
Up to date knowledge from Section I examine of antibody-drug conjugate EBC-129 launched (2025, June 3)
retrieved 3 June 2025
from https://medicalxpress.com/information/2025-06-phase-antibody-drug-conjugate-ebc.html
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