Accent Therapeutics宣布在2025年ASCO年会上展示ATX-559首次人体试验的进展海报-动脉网

Accent Therapeutics Announces Trial in Progress Poster for First-in-Human Study of ATX-559 at 2025 ASCO Annual Meeting

CISION 等信源发布 2025-05-23 05:00

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ATX-559, a first-in-class oral DHX9 inhibitor, is being evaluated in a Phase 1/2 study with a focus

ATX-559，一种首创的口服DHX9抑制剂，正在一项一期/二期研究中进行评估，重点是

on advanced or metastatic patients with BRCA-1 and/or BRCA-2-deficient breast cancer or

针对BRCA-1和/或BRCA-2缺陷的乳腺癌晚期或转移性患者

MSI-H and/or dMMR solid tumors

MSI-H 和/或 dMMR 实体瘤

LEXINGTON, Mass.

马萨诸塞州列克星敦

，

May 22, 2025

2025年5月22日

/PRNewswire/ -- Accent Therapeutics, a clinical-stage biopharmaceutical company pioneering novel, targeted, small molecule cancer therapeutics, today announced that a Trial in Progress poster for its first-in-human, Phase 1/2 study of its first-in-class oral DHX9 inhibitor, ATX-559, will be presented at the 2025 American Society of Clinical Oncology Annual Meeting, held .

/PRNewswire/ -- Accent Therapeutics是一家处于临床阶段的生物制药公司，致力于开发新型、靶向的小分子癌症治疗药物。该公司今天宣布，其首创的口服DHX9抑制剂ATX-559的首次人体1/2期研究的“正在进行的试验”海报将在2025年美国临床肿瘤学会年会上展示。

May 30-June 3

5月30日-6月3日

在

Chicago, Illinois

伊利诺伊州芝加哥市

。

'As a novel inhibitor of DHX9, a previously undrugged RNA and DNA/RNA helicase, ATX-559 offers potential as a unique therapeutic approach for addressing cancers characterized by high replication stress,' said

‘作为一种新型的DHX9抑制剂，ATX-559针对以前未被开发的RNA和DNA/RNA解旋酶，为应对高复制应激特征的癌症提供了独特的治疗潜力，’表示。

Jason Sager

杰森·塞格尔

, M.D., Chief Medical Officer of Accent Therapeutics. 'We are encouraged by the robust suite of data that continue to support the clinical evaluation of ATX-559 in our ongoing Phase 1/2 study.'

医学博士，Accent Therapeutics首席医疗官表示：“我们备受鼓舞的是，这些强有力的数据继续支持ATX-559在我们正在进行的1/2期研究中的临床评估。”

Initiated in late 2024, the first-in-human, Phase 1/2, open-label, dose-escalation and expansion study is designed to evaluate multiple doses of ATX-559 in solid tumor patients, with expansion cohorts of patients with advanced or metastatic BRCA-1 and/or BRCA-2-deficient breast cancer and microsatellite instability-high (MSI-H) and/or deficient mismatch repair (dMMR) solid tumors (.

2024年底启动的首次人体、1/2期、开放标签、剂量递增和扩展研究旨在评估ATX-559在实体瘤患者中的多种剂量，并针对晚期或转移性BRCA-1和/或BRCA-2缺陷型乳腺癌以及高微卫星不稳定性（MSI-H）和/或错配修复缺陷（dMMR）实体瘤患者设立扩展队列。

NCT06625515

). Primary endpoints include identification of the recommended Phase 2 dose (RP2D) and assessment of the safety and tolerability of ATX-559. The study additionally aims to characterize the pharmacokinetics (PK), pharmacodynamics (PD), and preliminary anti-tumor activity (as assessed per RECIST v1.1 criteria) of orally administered ATX-559.

). 主要终点包括确定推荐的二期剂量（RP2D）以及评估ATX-559的安全性和耐受性。该研究还旨在描述口服ATX-559的药代动力学（PK）、药效学（PD）和初步抗肿瘤活性（根据RECIST v1.1标准评估）。

The study is currently open and enrolling. Additional undisclosed solid tumor indications undergoing replicative stress and representing significant patient populations may be explored either in parallel or in subsequent studies..

该研究目前正在进行中并正在招募患者。可能会在平行或后续研究中探索其他未公开的、经历复制应激并代表显著患者群体的实体瘤适应症。

Details for the presentation are as follows:

演示文稿的详细信息如下：

Presentation Title:

演示标题：

Trial in Progress: First-in-Human Study of ATX-559, an Oral Inhibitor of DHX9, in Patients with Advanced or Metastatic Solid Tumors, and Molecularly Defined Cancers

正在进行的试验：ATX-559（一种DHX9口服抑制剂）在晚期或转移性实体瘤及分子定义癌症患者中的首次人体研究

Abstract Number

摘要编号

: TPS3181

：TPS3181

Session Type

会话类型

: Poster Session

：海报会议

Session Title

会议标题

: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology

：发育治疗学——分子靶向药物与肿瘤生物学

Session Date and Time

会话日期和时间

：

Monday, June 2

6月2日，星期一

，

1:30 pm

下午1点30分

–

4:30 pm CDT

下午4点30分（中部夏令时间）

Location

位置

: Hall A – Posters and Exhibits | On Demand

：A厅 - 海报和展览 | 随需应变

Presenter

主持人

：

Meredith Pelster

梅雷迪思·佩尔斯特

, M.D., M.Sc.

，医学博士，理学硕士

The poster will be available on the Accent Therapeutics website following the meeting.

会议结束后，海报将在 Accent Therapeutics 网站上提供。

About ATX-559

关于ATX-559

ATX-559 is a first-in-class potent and selective inhibitor of DHX9, a novel and previously undrugged RNA and DNA/RNA helicase, shown to play a critical role in tumors with high levels of replication stress (including breast, ovarian, colorectal, endometrial, gastric, and others), representing large patient populations with significant unmet medical need.

ATX-559 是一种首创的强效且选择性的 DHX9 抑制剂，DHX9 是一种新型的、此前未被药物靶向的 RNA 和 DNA/RNA 解旋酶，已被证明在具有高水平复制应激的肿瘤（包括乳腺癌、卵巢癌、结直肠癌、子宫内膜癌、胃癌等）中发挥关键作用，代表了具有显著未满足医疗需求的广大患者群体。

DHX9 has been reported to play important roles in replication, transcription, translation, RNA splicing, RNA processing, and maintenance of genomic stability, making it a compelling novel oncology target. In addition to exploiting key tumor vulnerabilities in DNA repair deficient backgrounds (e.g., BRCA) and hyper-mutated states (e.g., MSI-H/dMMR), Accent is exploring the sensitivity of other tumor types to DHX9 inhibition, and the potential to combine DHX9 inhibitors with other cancer treatments to maximize its full potential for helping patients.

DHX9 已被报道在复制、转录、翻译、RNA剪接、RNA加工和基因组稳定性维持中发挥重要作用，使其成为一个引人注目的新型肿瘤学靶点。除了利用DNA修复缺陷背景（如BRCA）和高突变状态（如MSI-H/dMMR）中的关键肿瘤脆弱性外，Accent还在探索其他肿瘤类型对DHX9抑制的敏感性，以及将DHX9抑制剂与其他癌症治疗方法结合的潜力，以充分释放其帮助患者的潜能。

Accent retains full worldwide rights to ATX-559, currently being evaluated in a Phase 1/2 clinical trial .

Accent 保留了 ATX-559 的全球权利，目前该药物正在 1/2 期临床试验中进行评估。

(NCT06625515)

, and the DHX9 program.

，以及DHX9程序。

About Accent Therapeutics

关于Accent Therapeutics

Accent Therapeutics is a clinical-stage biopharmaceutical company pioneering a new class of small molecule precision cancer therapies targeting critical intracellular dependencies that span multiple types of cancer. Building upon industry-leading expertise in RNA-modifying proteins (RMPs) and the systematic mapping of both the RMP space and adjacent high-value areas for drug discovery, the company employs a flexible model that allows for a diversity of approaches to developing potentially transformative biomarker-driven cancer medicines.

Accent Therapeutics是一家处于临床阶段的生物制药公司，致力于开发一类新的小分子精准癌症疗法，靶向多种癌症中关键的细胞内依赖性。基于在RNA修饰蛋白（RMPs）领域的行业领先专业知识，并结合对RMP领域及周边高价值药物发现区域的系统性图谱绘制，该公司采用灵活的研发模式，能够通过多样化的方法开发潜在变革性的、由生物标志物驱动的癌症药物。

Accent's therapies are designed for both novel and known, but suboptimally addressed, high-impact oncology targets with the potential to benefit large patient populations with significant unmet need. The company's two lead programs—ATX-559, targeting DHX9, and ATX-295, targeting KIF18A—are currently being evaluated in Phase 1/2 clinical studies.

Accent的疗法旨在针对新颖和已知但未得到充分解决的高影响力肿瘤靶点，这些靶点有可能使大量具有显著未满足需求的患者受益。该公司目前正在进行两项主要项目——ATX-559（靶向DHX9）和ATX-295（靶向KIF18A）——正处于1/2期临床研究评估阶段。

For more information on Accent's mission to translate extraordinary science into life-changing therapeutics for patients living with cancer, visit .

欲了解有关 Accent 致力于将非凡的科学转化为改变生命的癌症患者治疗方法的更多信息，请访问。

www.accenttx.com

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