CAMBRIDGE, Mass.

马萨诸塞州剑桥市

,

，

March 25, 2025

2025年3月25日

/PRNewswire/ --

/美通社/ --

Nuvalent, Inc.

努瓦莱特公司

(Nasdaq:

（纳斯达克：

NUVL

NUVL

), a clinical-stage biopharmaceutical company focused on creating

），一家专注于创造的临床阶段生物制药公司

precisely

准确地

targeted therapies for clinically proven kinase targets in cancer, today announced upcoming poster presentations further characterizing the preclinical profiles of its novel ALK-selective inhibitor, neladalkib, and novel ROS1-selective inhibitor, zidesamtinib, at the American Association for Cancer Research (AACR) Annual Meeting 2025 from .

针对癌症中临床验证的激酶靶点的靶向疗法，今日宣布将在2025年美国癌症研究协会（AACR）年会上发布海报展示，进一步描述其新型ALK选择性抑制剂neladalkib和新型ROS1选择性抑制剂zidesamtinib的临床前特性。

April 25-30, 2025

2025年4月25日至30日

, in

，在

Chicago

芝加哥

.

。

Details of the poster presentations are as follows:

海报展示的详细信息如下：

Title:

标题：

Mutagenesis screens support potential best-in-class profile for neladalkib (NVL-655), a brain-penetrant and TRK-sparing ALK inhibitor

诱变筛选支持neladalkib（NVL-655）潜在的最佳性能，这是一种可穿透大脑且不抑制TRK的ALK抑制剂。

Authors:

作者：

Anupong Tangpeerachaikul*

阿努蓬·唐皮拉查库尔*

1

1

,

，

Henry E. Pelish

亨利·E·佩利什

1

1

Abstract Number:

摘要编号：

1729

1729

Session Category:

会话类别：

Experimental and Molecular Therapeutics

实验与分子治疗学

Session Title:

会话标题：

Kinase and Phosphatase Inhibitors 1

激酶和磷酸酶抑制剂 1

Session Date and Time:

会议日期和时间：

April 28, 2025

2025年4月28日

, from 9:00 a.m.–

，从上午9:00开始——

12:00 p.m. CT

中午12点（中部时间）

Location:

位置：

Poster Section 21

海报部分 21

Poster Board Number:

海报板编号：

4

4

Title:

标题：

Crystal structure of drug-resistant ROS1 G2032R in complex with zidesamtinib, a clinical-stage ROS1 inhibitor with best-in-class potential

耐药性ROS1 G2032R与临床阶段的ROS1抑制剂齐德萨替尼复合物的晶体结构，该抑制剂具有同类最佳潜力。

Authors:

作者：

Joseph M. Magrino

约瑟夫·M·马格里诺

*

*

1

1

, Anupong Tangpeerachaikul

，阿努蓬·唐皮拉查库尔

1

1

,

，

Scot Mente

斯科特·门特

1

1

,

，

Henry E. Pelish

亨利·E·佩利什

1

1

Abstract Number:

摘要编号：

5616

5616

Session Category:

会话类别：

Experimental and Molecular Therapeutics

实验和分子治疗学

Session Title:

会议标题：

Kinase and Phosphatase Inhibitors 3

激酶和磷酸酶抑制剂 3

Session Date and Time:

会议日期和时间：

April 29, 2025

2025年4月29日

, from 2:00 p.m.–

，从下午2:00开始——

5:00 p.m. CT

下午5:00（中部时间）

Location:

位置：

Poster Section 20

海报部分 20

Poster Board Number:

海报板编号：

26

26

*Presenter, corresponding author;

*报告人，通讯作者；

1

1

Nuvalent, Inc.,

努瓦莱特公司，

Cambridge, MA

马萨诸塞州剑桥市

, USA

，美国

About Zidesamtinib

关于齐德萨替尼

Zidesamtinib is a novel brain-penetrant ROS1-selective inhibitor created with the aim to overcome limitations observed with currently available ROS1 inhibitors. Zidesamtinib is designed to remain active in tumors that have developed resistance to currently available ROS1 inhibitors, including tumors with treatment-emergent ROS1 mutations such as G2032R.

Zidesamtinib 是一种新型的可穿透大脑的 ROS1 选择性抑制剂，旨在克服目前可用的 ROS1 抑制剂所观察到的局限性。Zidesamtinib 的设计目标是，在对现有 ROS1 抑制剂产生耐药性的肿瘤中仍然保持活性，包括具有治疗后出现的 ROS1 突变（如 G2032R）的肿瘤。

In addition, zidesamtinib is designed for central nervous system (CNS) penetrance to improve treatment options for patients with brain metastases, and to avoid inhibition of the structurally related tropomyosin receptor kinase (TRK) family. Together, these characteristics have the potential to avoid TRK-related CNS adverse events seen with dual TRK/ROS1 inhibitors and to drive deep, durable responses for patients across all lines of therapy.

此外，zidesamtinib 旨在穿透中枢神经系统 (CNS)，以改善脑转移患者治疗选择，并避免抑制结构相关的肌球蛋白受体激酶 (TRK) 家族。这些特性共同有可能避免与双重 TRK/ROS1 抑制剂相关的 TRK 相关中枢神经系统不良事件，并为各线治疗的患者带来深度且持久的反应。

Zidesamtinib has received breakthrough therapy designation for the treatment of patients with ROS1-positive metastatic non-small cell lung cancer (NSCLC) who have been previously treated with 2 or more ROS1 tyrosine kinase inhibitors and orphan drug designation for ROS1-positive NSCLC..

Zidesamtinib 已获得突破性疗法认定，用于治疗先前接受过两种或更多种 ROS1 酪氨酸激酶抑制剂治疗的 ROS1 阳性转移性非小细胞肺癌（NSCLC）患者，并获得了 ROS1 阳性 NSCLC 的孤儿药认定。

About Neladalkib

关于Neladalkib

Neladalkib is a novel brain-penetrant ALK-selective inhibitor created with the aim to overcome limitations observed with currently available ALK inhibitors. Neladalkib is designed to remain active in tumors that have developed resistance to first-, second-, and third-generation ALK inhibitors, including tumors with single or compound treatment-emergent ALK mutations such as G1202R.

Neladalkib 是一种新型的可穿透大脑的 ALK 选择性抑制剂，旨在克服目前可用的 ALK 抑制剂所观察到的局限性。Neladalkib 的设计使其在对第一、第二和第三代 ALK 抑制剂产生耐药性的肿瘤中仍然有效，包括具有单个或复合治疗出现的 ALK 突变（如 G1202R）的肿瘤。

In addition, neladalkib is designed for central nervous system (CNS) penetrance to improve treatment options for patients with brain metastases, and to avoid inhibition of the structurally related tropomyosin receptor kinase (TRK) family. Together, these characteristics have the potential to avoid TRK-related CNS adverse events seen with dual TRK/ALK inhibitors and to drive deep, durable responses for patients across all lines of therapy.

此外，neladalkib 旨在穿透中枢神经系统 (CNS)，以改善脑转移患者治疗选择，并避免抑制结构相关的肌球蛋白受体激酶 (TRK) 家族。这些特性共同有可能避免使用双重 TRK/ALK 抑制剂时出现的 TRK 相关 CNS 不良事件，并为所有治疗线的患者带来深度且持久的反应。

Neladalkib has received breakthrough therapy designation for the treatment of patients with locally advanced or metastatic ALK-positive non-small cell lung cancer (NSCLC) who have been previously treated with 2 or more ALK tyrosine kinase inhibitors and orphan drug designation for ALK-positive NSCLC..

尼拉达克里布获得了突破性疗法认定，用于治疗先前接受过两种或更多种ALK酪氨酸激酶抑制剂治疗的局部晚期或转移性ALK阳性非小细胞肺癌（NSCLC）患者，并获得了针对ALK阳性NSCLC的孤儿药认定。

About Nuvalent

关于Nuvalent

Nuvalent, Inc. (Nasdaq:

努瓦莱特公司（纳斯达克：

NUVL

NUVL

) is a clinical-stage biopharmaceutical company focused on creating

）是一家处于临床阶段的生物制药公司，专注于创造

precisely

准确地

targeted therapies for patients with cancer, designed to overcome the limitations of existing therapies for clinically proven kinase targets. Leveraging deep expertise in chemistry and structure-based drug design, we develop innovative small molecules that have the potential to overcome resistance, minimize adverse events, address brain metastases, and drive more durable responses.

针对癌症患者的靶向疗法，旨在克服现有疗法在临床上已验证的激酶靶点的局限性。凭借在化学和基于结构的药物设计方面的深厚专业知识，我们开发创新的小分子药物，有望克服耐药性、减少不良反应、应对脑转移并实现更持久的治疗效果。

Nuvalent is advancing a robust pipeline with investigational candidates for ROS1-positive, ALK-positive, and HER2-altered non-small cell lung cancer, and multiple discovery-stage research programs..

Nuvalent正在推进一条强大的研发管线，其中包括针对ROS1阳性、ALK阳性和HER2突变的非小细胞肺癌的研究候选药物，以及多个处于发现阶段的研究项目。

Forward-Looking Statements

前瞻性声明

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, implied and express statements regarding Nuvalent's strategy, business plans, and focus; the expected timing of data announcements; the potential benefits and effects of Nuvalent's product development candidates; the potential of Nuvalent's pipeline programs, including zidesamtinib and neladalkib; Nuvalent's research and development programs for the treatment of cancer; and risks and uncertainties associated with drug development.

本新闻稿包含1995年《私人证券诉讼改革法案》（经修订）所指的前瞻性陈述，包括但不限于关于Nuvalent的战略、业务计划和重点的明示或暗示陈述；数据发布的预期时间；Nuvalent产品开发候选物的潜在益处和效果；Nuvalent的管线项目潜力，包括zidesamtinib和neladalkib；Nuvalent针对癌症治疗的研发计划；以及与药物开发相关的风险和不确定性。

The words 'may,' 'might,' 'will,' 'could,' 'would,' 'should,' 'expect,' 'plan,' 'anticipate,' 'aim,' 'goal,' 'intend,' 'believe,' 'expect,' 'estimate,' 'seek,' 'predict,' 'future,' 'project,' 'potential,' 'continue,' 'target' or the negative of these terms and similar words or expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

“可能”、“也许”、“将”、“可以”、“会”、“应该”、“预期”、“计划”、“预期”、“目标”、“目的”、“打算”、“相信”、“估计”、“寻求”、“预测”、“未来”、“项目”、“潜力”、“继续”、“目标”等词语或这些词语的否定形式以及类似的表达，旨在识别前瞻性陈述，尽管并非所有前瞻性陈述都包含这些识别性词语。

Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. You should not place undue reliance on these statements or the scientific data presented..

药物的开发和商业化涉及高度风险，只有极少数的研发项目能够成功实现产品的商业化。您不应过度依赖这些声明或所提供的科学数据。

Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties, and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation: unexpected concerns that may arise from additional data, analysis, or results obtained during preclinical studies and clinical trials; the risk that results of earlier clinical trials may not be predictive of the results of later-stage clinical trials; the risk that data from our clinical trials may not be sufficient to support registration and that Nuvalent may be required to conduct one or more additional studies or trials prior to seeking registration of our zidesamtinib or neladalkib product candidates; the occurrence of adverse safety events; risks that the FDA may not approve our potential products on the timelines we expect, or at all; risks of unexpected costs, delays, or other unexpected hurdles; risks that Nuvalent may not be able to nominate drug candidates from its discovery programs; the direct or indirect impact of public health emergencies or global geopolitical circumstances on the timing and anticipated timing and results of Nuvalent's clinical trials, strategy, and future operations; the timing and outcome of Nuvalent's planned interactions with regulatory authorities; and risks related to obtaining, maintaining, and protecting Nuvalent's intellectual property.

本新闻稿中的任何前瞻性陈述均基于管理层的当前预期和信念，并受到许多风险、不确定性和重要因素的影响，这些因素可能导致实际事件或结果与本新闻稿中包含的任何前瞻性陈述所表达或暗示的内容存在重大差异，包括但不限于：在临床前研究和临床试验期间从额外数据、分析或结果中可能出现的意外问题；早期临床试验结果可能无法预测后期临床试验结果的风险；我们临床试验的数据可能不足以支持注册，Nuvalent 可能需要在寻求注册 zidesamtinib 或 neladalkib 候选产品之前进行一项或多项额外研究或试验的风险；发生不良安全事件的风险；FDA 可能不会按照我们预期的时间表批准我们的潜在产品，甚至完全不批准的风险；出现意外成本、延误或其他意外障碍的风险；Nuvalent 可能无法从其发现计划中提名候选药物的风险；公共卫生紧急事件或全球地缘政治局势对 Nuvalent 临床试验、战略及未来运营的时机及预期结果产生的直接或间接影响；Nuvalent 计划与监管机构互动的时机和结果；以及与获取、维护和保护 Nuvalent 知识产权相关的风险。

These and other risks and uncertainties are described in greater detail in the section entitled 'Risk Factors' in Nuvalent's Annual Report on Form 10-K for the fiscal year ended December 31, 2024, as well as any prior and su.

这些以及其他风险和不确定性在 Nuvalent 截至 2024 年 12 月 31 日的财政年度 Form 10-K 年度报告中“风险因素”部分有更详细的描述，以及任何先前和随后的文件中也有提及。

SOURCE Nuvalent, Inc.

来源：Nuvalent, Inc.

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