Presentation highlights first clinical study of ATX-295, a potentially best-in-class oral KIF18A inhibitor, in patients with advanced or metastatic solid tumors

演示亮点为ATX-295的首项临床研究，这是一种潜在的最佳口服KIF18A抑制剂，用于治疗晚期或转移性实体瘤患者。

LEXINGTON, Mass.

马萨诸塞州列克星敦

,

，

May 21, 2026

2026年5月21日

/PRNewswire/ -- Accent Therapeutics, a clinical-stage biopharmaceutical company pioneering novel small molecule precision cancer therapies, today announced it will present a Trial in Progress poster describing its ongoing Phase 1/2 first-in-human clinical study of ATX-295 at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place May 29 – June 2 in Chicago, Illinois..

/PRNewswire/ -- Accent Therapeutics是一家处于临床阶段的生物制药公司，致力于开创新型小分子精准癌症疗法，今天宣布将在2026年美国临床肿瘤学会（ASCO）年会上展示一张“正在进行的试验”海报，介绍其正在进行的ATX-295首次人体1/2期临床研究。该会议将于5月29日至6月2日在伊利诺伊州芝加哥举行。

'KIF18A inhibition offers a differentiated approach to exploiting a fundamental vulnerability in chromosomally instable tumors including high grade serous ovarian cancer (HGSOC) and squamous non-small cell lung cancer (sqNSCLC). ATX-295 is grounded in a strong body of preclinical evidence that continues to deepen our conviction in this program,' said Jason Sager, M.D., Chief Medical Officer of Accent Therapeutics.

“KIF18A抑制剂提供了一种差异化的方法，利用了染色体不稳定的肿瘤（包括高级别浆液性卵巢癌（HGSOC）和鳞状非小细胞肺癌（sqNSCLC））中的基本脆弱性。ATX-295基于大量的临床前证据，这些证据不断加深我们对该计划的信心，”Accent Therapeutics首席医学官Jason Sager博士表示。

'We have built a rigorous clinical development plan focused on treating cancers with high unmet need, and we hope to ultimately deliver a meaningful new targeted oncology option for patients with limited therapeutic alternatives.'.

“我们已经制定了一项严格的临床开发计划，专注于治疗那些未满足需求的癌症，并希望最终为治疗选择有限的患者提供一种有意义的新型靶向肿瘤学方案。”

ATX-295 is a potentially best-in-class inhibitor of KIF18A, a mitotic kinesin motor protein critical for cell division in select tumors with chromosomal instability.

ATX-295 是一种潜在的同类最佳 KIF18A 抑制剂，KIF18A 是一种有丝分裂运动蛋白，在具有染色体不稳定的特定肿瘤中对细胞分裂至关重要。

The Trial in Progress poster will describe the design and scientific rationale for Accent's first-in-human Phase 1/2 dose-escalation and expansion study evaluating the safety, tolerability, and preliminary efficacy of ATX-295 in patients with locally advanced or metastatic solid tumors (

正在进行的试验海报将描述 Accent 首次人体试验的 Phase 1/2 剂量递增和扩展研究的设计及科学依据，该研究旨在评估 ATX-295 在局部晚期或转移性实体瘤患者中的安全性、耐受性和初步疗效。

NCT06799065

NCT06799065

), including HGSOC and sqNSCLC.

），包括HGSOC和sqNSCLC。

The study comprises an initial dose-escalation phase to determine the recommended Phase 2 dose (RP2D), followed by a dose-expansion phase to assess preliminary antitumor activity. Primary endpoints include evaluation of the safety and tolerability of ATX-295 and determination of the RP2D. Secondary endpoints include assessment of pharmacokinetics (PK), pharmacodynamic (PD) effects, and preliminary antitumor activity.

该研究包括一个初始剂量递增阶段以确定推荐的二期剂量（RP2D），随后是剂量扩展阶段以评估初步的抗肿瘤活性。主要终点包括评估ATX-295的安全性和耐受性以及确定RP2D。次要终点包括药代动力学（PK）、药效学（PD）效应和初步抗肿瘤活性的评估。

The Phase 1/2 study is currently open and actively enrolling patients..

第1/2阶段的研究目前正在进行，并且正在积极招募患者。

Details for the presentation are as follows:

演示文稿的详细信息如下：

Poster Title:

海报标题：

Trial in Progress: A Phase 1/2 First-in-Human Study of ATX-295, an Oral Inhibitor of KIF18A, in Patients with Advanced or Metastatic Solid Tumors, Including Ovarian Cancer

试验进行中：ATX-295（一种KIF18A口服抑制剂）在晚期或转移性实体瘤（包括卵巢癌）患者中的首次人体1/2期研究

Abstract Number

摘要编号

: TPS3167

: TPS3167

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

: Saturday, May 30, 1:30 – 4:30 PM CDT

：5月30日，星期六，下午1:30 – 4:30（中部夏令时间）

Location:

位置：

Hall A – Posters and Exhibits

A厅 - 海报和展览

Presenter

主持人

: Judy S. Wang, MD, Florida Cancer Specialists/Sarah Cannon Research Institute

朱迪·S·王医学博士，佛罗里达癌症专家/莎拉·坎农研究所

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-295

关于ATX-295

Accent's lead program, ATX-295, is a potential best-in-class inhibitor for KIF18A, a mitotic kinesin motor protein critical for cell division in select tumors with chromosomal instability. KIF18A inhibitor treatment results in rapid cell death for cancers with an abnormal number of chromosomes (aneuploid) .

Accent公司的主要项目ATX-295是一种潜在的同类最佳KIF18A抑制剂，KIF18A是一种在具有染色体不稳定性选择性肿瘤中对细胞分裂至关重要的有丝分裂运动蛋白。KIF18A抑制剂治疗会导致染色体数量异常（非整倍体）的癌细胞快速死亡。

in vitro

体外

and

和

in vivo

体内

, while cells with normal numbers of chromosomes (euploid) are unaffected. ATX-295 may address a large patient population across several cancer indications, including ovarian and squamous non-small cell lung cancer. Accent retains full worldwide rights to the KIF18A program, currently being evaluated in an ongoing Phase 1/2 clinical study .

，而染色体数目正常的细胞（整倍体）则不受影响。ATX-295可能覆盖多个癌症适应症的广泛患者群体，包括卵巢癌和鳞状非小细胞肺癌。Accent公司保留了KIF18A项目在全球的全部权利，该项目目前正在一项正在进行的1/2期临床研究中进行评估。

(NCT06799065)

(NCT06799065)

enrolling patients with locally advanced or metastatic solid tumors, including high-grade serous ovarian cancer and squamous non-small cell lung cancer.

招募局部晚期或转移性实体瘤患者，包括高级别浆液性卵巢癌和鳞状非小细胞肺癌。

About Accent Therapeutics

关于Accent Therapeutics

Accent Therapeutics is a clinical-stage biopharmaceutical company pioneering novel small molecule precision cancer therapies. Accent is leveraging its industry-leading expertise to prosecute novel tumor vulnerabilities in cancers with high genomic and chromosomal instability. Accent's innovative therapies are designed for high-impact oncology targets with the potential to benefit large patient populations with significant unmet need.

Accent Therapeutics是一家临床阶段的生物制药公司，致力于开发新型小分子精准癌症疗法。Accent凭借其行业领先的专业知识，针对具有高度基因组和染色体不稳定性癌症中的新型肿瘤脆弱性进行研究。Accent的创新疗法专注于高影响力的肿瘤学靶点，有望为大量存在显著未满足需求的患者群体带来益处。

The company's lead program — ATX-295, targeting KIF18A — is currently being evaluated in Phase 1/2 clinical studies. For more information on Accent's mission to translate extraordinary science into life-changing therapeutics for patients living with cancer, visit .

该公司的主要项目——针对KIF18A的ATX-295——目前正在1/2期临床研究中进行评估。如需了解更多关于Accent公司致力于将非凡的科学转化为改变生命的癌症治疗药物的信息，请访问。

www.accenttx.com

www.accenttx.com

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Media Contact

媒体联系人

Amanda Sellers, Deerfield Group

阿曼达·塞勒斯，鹿田集团

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SOURCE Accent Therapeutics

来源：Accent Therapeutics

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