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March 18, 2026

2026年3月18日

/PRNewswire/ -- Biotheryx, Inc., a biopharmaceutical company focused on the discovery and development of first-in-class protein degraders for cancer and inflammatory diseases, today announced that the first patient has been dosed in the dose expansion phase of its clinical trial evaluating BTX-9341, a potent and selective CDK4/6 degrader, in combination with fulvestrant for the treatment of HR+/HER2- breast cancer in patients who have previously received CDK4/6 inhibitor therapy in the advanced and/or metastatic setting..

/PRNewswire/ -- Biotheryx, Inc. 是一家专注于发现和开发用于治疗癌症和炎症性疾病的一流蛋白降解剂的生物制药公司，今天宣布，在其评估 BTX-9341（一种强效且选择性的 CDK4/6 降解剂）与氟维司群联合治疗 HR+/HER2- 乳腺癌患者的临床试验剂量扩展阶段中，第一名患者已经完成给药。这些患者此前在晚期和/或转移性环境中曾接受过 CDK4/6 抑制剂治疗。

The dose expansion portion of the trial is a randomized study designed to evaluate the efficacy and safety of BTX-9341 in combination with fulvestrant. The trial is being conducted at multiple sites in the United States and is expected to enroll approximately 80 patients across two treatment arms based on the recommended dose identified in the earlier dose escalation phase.

试验的剂量扩展部分是一项随机研究，旨在评估BTX-9341联合氟维司群的疗效和安全性。该试验正在美国的多个地点进行，预计将在两个治疗组中招募约80名患者，这些治疗组基于早期剂量递增阶段确定的推荐剂量。

This dose expansion study builds on the recently completed dose escalation phase that evaluated the safety, tolerability, pharmacokinetics and pharmacodynamic activity of BTX-9341. The primary endpoint of this study is the Overall Response Rate (ORR), with key secondary endpoints including the measurement of investigator-assessed Clinical Benefit Rate (CBR) and Progression Free Survival (PFS)..

这项剂量扩展研究基于最近完成的剂量递增阶段，该阶段评估了BTX-9341的安全性、耐受性、药代动力学和药效学活性。本研究的主要终点是总体缓解率（ORR），关键次要终点包括研究者评估的临床获益率（CBR）和无进展生存期（PFS）的测量。

'We are pleased to have dosed the first patient in the dose expansion portion of our clinical trial evaluating BTX-9341 in combination with fulvestrant.' said Dr. Leah Fung, Chief Executive Officer of Biotheryx. 'The encouraging safety, pharmacokinetics, and preliminary activity observed in the earlier dose escalation portion of the study support advancing BTX-9341 into this next stage of clinical evaluation.

“我们很高兴在评估BTX-9341与氟维司群联合使用的临床试验的剂量扩展部分中，完成了首位患者的给药。” Biotheryx首席执行官Leah Fung博士表示，“在研究早期剂量递增阶段观察到的良好安全性、药代动力学和初步活性，支持将BTX-9341推进到这一下一阶段的临床评估。”

We believe the differentiated mechanism of targeted CDK4/6 degradation has the potential to address resistance seen with currently available CDK4/6 inhibitors, and we look forward to further assessing BTX-9341 in combination with fulvestrant to improve outcomes for patients with HR+/HER2- breast cancer who have previously received CDK4/6 inhibitor therapy.'  .

我们相信，靶向CDK4/6降解的差异化机制有潜力解决目前可用的CDK4/6抑制剂所出现的耐药性问题。我们期待进一步评估BTX-9341与氟维司群联合使用，以改善先前接受过CDK4/6抑制剂治疗的HR+/HER2-乳腺癌患者的预后。

About BTX-9341

关于BTX-9341

BTX-9341 is a first-in-class, oral degrader of CDK4/6, important targets for a range of cancers and clinically validated in HR+/HER2- breast cancer. In preclinical breast cancer models, BTX-9341 demonstrated superiority to CDK4/6 inhibitors through potent and highly selective catalytic degradation of CDK4 and CDK6, robust inhibition of CDK2 and Cyclin E transcription, cell cycle arrest, and ultimately superior .

BTX-9341 是一种首创的口服CDK4/6降解剂，是多种癌症的重要靶点，并在HR+/HER2-乳腺癌中得到了临床验证。在乳腺癌的临床前模型中，BTX-9341通过强效且高度选择性的CDK4和CDK6催化降解、对CDK2和Cyclin E转录的强力抑制、细胞周期阻滞，最终展现出优于CDK4/6抑制剂的效果。

in vivo

体内

efficacy in breast cancer xenografts. Beyond this increased efficacy potential, BTX-9341 is differentiated from CDK4/6 inhibitor approaches through the ability to overcome key resistance mechanisms that limit the impact of inhibitors in second line HR+/HER2- metastatic breast cancer.

在乳腺癌异种移植模型中显示出疗效。除了这种增强的疗效潜力外，BTX-9341通过克服限制CDK4/6抑制剂在二线HR+/HER2-转移性乳腺癌中作用的关键耐药机制，与CDK4/6抑制剂方法区分开来。

About Biotheryx, Inc.

关于Biotheryx公司

Biotheryx is a clinical-stage, biopharmaceutical company discovering and developing a portfolio of first-in-class protein degraders, including molecular glues and bifunctional degraders. Members of our founding and scientific teams previously developed the first U.S. Food and Drug Administration (FDA) approved modulators of Cereblon, the most widely validated E3 ligase involved in protein degradation.

Biotheryx是一家临床阶段的生物制药公司，致力于发现和开发一系列首创的蛋白质降解剂，包括分子胶和双功能降解剂。我们的创始团队和科学团队成员曾开发出首个获得美国食品药品监督管理局（FDA）批准的Cereblon调节剂，Cereblon是最广泛验证的参与蛋白质降解的E3连接酶。

We have applied our expertise in Cereblon modulation to build our proprietary PRODEGY platform and pipeline of protein degraders for oncology and inflammatory diseases. Our approach deploys molecular glues to target undruggable proteins and bifunctional degraders to target validated proteins that conventional strategies, like protein inhibition, have insufficiently addressed.

我们运用了在Cereblon调节方面的专业知识，构建了我们的专有PRODEGY平台及用于肿瘤学和炎症性疾病的蛋白质降解剂管线。我们的方法采用分子胶靶向不可成药的蛋白质，并使用双功能降解剂靶向传统策略（如蛋白质抑制）未能充分解决的已验证蛋白质。

The Biotheryx pipeline includes BTX-9341, a first-in-class, oral, CDK4/6 bifunctional degrader that inhibits the transcription of CDK2 and Cyclin E, in first-in-human dose escalation and optimization clinical study in HR+/HER2- breast cancer patients who have progressed on CDK4/6 inhibitor therapy. Our pre-clinical pipeline advances undisclosed bifunctional degraders and molecular glues, including degraders as payloads for antibody drug conjugation.

Biotheryx的研发管线包括BTX-9341，这是一种首创的口服CDK4/6双功能降解剂，能够抑制CDK2和Cyclin E的转录，目前正在进行针对接受过CDK4/6抑制剂治疗后病情进展的HR+/HER2-乳腺癌患者的首次人体剂量递增与优化临床研究。我们的临床前管线正在推进未公开的双功能降解剂和分子胶，其中包括作为抗体药物偶联物有效载荷的降解剂。

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www.biotheryx.com

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SOURCE Biotheryx, Inc.

源生物治疗公司

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