实验性药物开发中心的抗体药物偶联物EBC-129获美国FDA快速通道指定，用于治疗胰腺导管腺癌-动脉网

Experimental Drug Development Centre Granted U.S. FDA Fast Track Designation for Antibody-Drug Conjugate EBC-129 to Treat Pancreatic Ductal Adenocarcinoma

CISION 等信源发布 2025-05-28 14:00

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EBC-129 is the first made-in-

EBC-129是第一个国产的-

Singapore

新加坡

antibody-drug conjugate (ADC) to enter clinical development. It selectively targets a tumour-specific N-glycosylated epitope on both CEACAM5 and CEACAM6.

抗体药物偶联物 (ADC) 进入临床开发阶段。它选择性地靶向CEACAM5和CEACAM6上肿瘤特异性的N-糖基化表位。

The Fast Track Designation highlights the potential of EBC-129 to address critical unmet needs in pancreatic ductal adenocarcinoma (PDAC).

快速通道资格强调了EBC-129在胰腺导管腺癌（PDAC）中满足关键未满足需求的潜力。

Updated clinical data from the ongoing Phase 1 study of EBC-129 will be presented at the 2025 Annual Meeting of the American Society of Clinical Oncology (ASCO).

EBC-129正在进行的I期研究的最新临床数据将在2025年美国临床肿瘤学会（ASCO）年会上公布。

SINGAPORE

新加坡

，

May 28, 2025

2025年5月28日

/PRNewswire/ -- The Experimental Drug Development Centre (EDDC),

/PRNewswire/ -- 新加坡实验药物研发中心（EDDC），

Singapore's

新加坡的

national platform for drug discovery and development, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for EBC-129 for the treatment of pancreatic ductal adenocarcinoma (PDAC). EBC-129 is a first-in-class antibody drug conjugate (ADC) targeting a novel, tumour-specific N256-glycosylated epitope on CEACAM5 and CEACAM6.

国家药物发现与开发平台今日宣布，美国食品药品监督管理局（FDA）已授予EBC-129快速通道资格，用于治疗胰腺导管腺癌（PDAC）。EBC-129是一种首创的抗体药物偶联物（ADC），靶向CEACAM5和CEACAM6上一种新型的、肿瘤特异性的N256糖基化表位。

It is currently undergoing Phase 1 clinical trials for the treatment of patients with solid tumours with high unmet medical need..

它目前正在针对具有高度未满足医疗需求的实体瘤患者进行一期临床试验。

The Fast Track Designation facilitates the expedited development of EBC-129, enabling more frequent engagement with the FDA to discuss the clinical development plan. It also provides potential eligibility for Priority Review and Accelerated Approval, as well as rolling review of any future Biologic License Application (BLA)..

快速通道资格促进了EBC-129的加速开发，使得与FDA更频繁地讨论临床开发计划成为可能。它还提供了优先审查和加速批准的潜在资格，以及任何未来生物制品许可申请（BLA）的滚动审查机会。

'The FDA's Fast Track Designation for EBC-129 underscores the promise of this novel ADC in addressing the critical need for expanded treatment options for PDAC patients and represents an important step in our efforts to accelerate its development. 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,' said Professor .

“FDA对EBC-129的快速通道指定凸显了这种新型ADC在满足胰腺癌患者对扩展治疗选择的关键需求方面的潜力，并代表了我们加速其开发的重要一步。我们认为这既是对我们努力的肯定，也是一种责任，促使我们果断推进EBC-129，为有需要的患者提供新的治疗选择，”教授表示。

Damian O'Connell

达米安·奥康奈尔

, Chief Executive Officer of EDDC.

EDDC首席执行官。

Updated clinical data from the

更新的临床数据来自于

ongoing Phase 1 study

正在进行的1期研究

of EBC-129 will be presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place in

EBC-129 的相关数据将在 2025 年美国临床肿瘤学会 (ASCO) 年会上发布，会议将于

Chicago

芝加哥

from 30 May to

从5月30日到

3 June 2025

2025年6月3日

。

Presentation Details at ASCO 2025:

ASCO 2025年会议详情：

Title:

标题：

Clinical activity of EBC-129, a first-in class, anti-N256-glycosylated CEACAM5 and CEACAM6 antibody-drug conjugate (ADC), in patients with pancreatic ductal adenocarcinoma (PDAC) in a Phase 1 study

EBC-129是一种首创的抗N256糖基化CEACAM5和CEACAM6抗体药物偶联物（ADC），在1期研究中针对胰腺导管腺癌（PDAC）患者的临床活性

Rapid Oral Session Title:

快速口头报告会标题：

Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary

胃肠道癌症——胃食管、胰腺和肝胆

Date and Time:

日期和时间：

Monday, June 2, 2025,

2025年6月2日，星期一，

11:30 AM

上午11点30分

–

1:00 PM GMT

下午1:00 GMT

-5

Abstract Number:

摘要编号：

4018

Presenter:

主持人：

Assistant Professor

助理教授

Robert W. Lentz

罗伯特·W·伦茨

, MD, Division of Medical Oncology, Department of Medicine,

医学博士，内科肿瘤学部，医学系，

University of Colorado

科罗拉多大学

Anschutz School of Medicine

安舒茨医学院

About EBC-129

关于EBC-129

EBC-129 is an ADC that targets a tumour-specific N256-glycosylation site conserved on CEACAM5 and CEACAM6. CEACAM5 and CEACAM6 are known to have functional importance in tumour formation, migration and metastasis. In the ongoing trial, the tumour-specific marker is found to be widely expressed in multiple solid tumour types, including gastric, oesophageal, pancreatic, lung, colorectal, and appendiceal cancers, based on an analytically validated immunohistochemistry (IHC) assay.

EBC-129是一种ADC，靶向在CEACAM5和CEACAM6上保守的肿瘤特异性N256糖基化位点。已知CEACAM5和CEACAM6在肿瘤形成、迁移和转移中具有功能性重要性。在正在进行的试验中，基于经分析验证的免疫组织化学（IHC）检测，发现该肿瘤特异性标志物在多种实体瘤类型中广泛表达，包括胃癌、食管癌、胰腺癌、肺癌、结直肠癌和阑尾癌。

The payload used in EBC-129 is monomethyl auristatin E (MMAE) which has been extensively tested and approved for clinical use in other marketed ADCs and has demonstrated synergy with PD-1 inhibitors. The ongoing Phase 1 trial of EBC-129 is assessing the safety and tolerability of EBC-129 as a single agent and in combination with pembrolizumab in patients with advanced solid tumours.

EBC-129中使用的载荷是单甲基澳瑞他汀E（MMAE），该载荷已在其他上市的抗体药物偶联物（ADC）中经过广泛测试并获批用于临床，同时显示出与PD-1抑制剂的协同作用。EBC-129正在进行的I期试验正在评估EBC-129作为单药以及与帕博利珠单抗联合使用时在晚期实体瘤患者中的安全性和耐受性。

Enrolment for the PDAC cohort in the Phase 1 dose expansion study is now complete, while recruitment continues for the gastroesophageal adenocarcinoma (GEA) and IHC-positive cohorts..

PDAC队列在第一阶段剂量扩展研究的入组现已完成，而胃食管腺癌（GEA）和IHC阳性队列的招募仍在继续。

For information about the trial, please visit

有关试验的更多信息，请访问

Clinicaltrial.gov, trial identifier NCT05701527

临床试验.gov，试验标识符 NCT05701527

。

About the Experimental Drug Development Centre

关于实验药物开发中心

The Experimental Drug Development Centre (EDDC) is

实验药物开发中心（EDDC）是

Singapore's

新加坡的

national platform for drug discovery and development, formed from the integration of the Experimental Therapeutics Centre (ETC), Drug Discovery and Development (D3), and Experimental Biotherapeutics Centre (EBC) in 2019. EDDC aims to develop therapeutics and diagnostics that save and improve the lives of patients in .

2019年，实验治疗中心（ETC）、药物发现与开发（D3）以及实验生物治疗中心（EBC）整合形成了一个全国性的药物发现与开发平台。EDDC旨在开发拯救和改善患者生命的治疗和诊断方法。

Singapore

新加坡

，

Asia

亚洲

and around the world. Hosted by the Agency for Science, Technology and Research (A*STAR), EDDC works collaboratively with public sector and industry partners to translate the great science arising from

并遍布全球。由新加坡科技研究局 (A*STAR) 主办，EDDC 与公共部门和行业合作伙伴协作，将产生的卓越科学转化为成果。

Singapore's

新加坡的

biomedical and clinical sciences R&D into innovative healthcare solutions. For more information about EDDC, please visit

生物医学和临床科学研发创新医疗解决方案。欲了解有关EDDC的更多信息，请访问

www.eddc.sg

。

SOURCE EXPERIMENTAL DRUG DEVELOPMENT CENTRE

源实验药物开发中心

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