/PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ:IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, announced the clearance of an investigational new drug (IND) application with the U.S. Food and Drug Administration (FDA) for the initiation of a Phase 1 clinical trial to evaluate IDE849 (SHR-4849), a potential first-in-class delta-like ligand 3 (DLL3)-targeting Topo-I-payload antibody drug conjugate (ADC) program, in solid tumors..

/PRNewswire/ -- IDEAYA Biosciences, Inc.（纳斯达克股票代码：IDYA），一家致力于发现和开发靶向治疗药物的精准医疗肿瘤公司，宣布美国食品药品监督管理局（FDA）已批准其研究性新药（IND）申请，将启动一项 I 期临床试验，以评估 IDE849 (SHR-4849)，一种潜在的首创 delta 样配体 3 (DLL3) 靶向的拓扑异构酶-I-有效载荷抗体药物偶联物（ADC）项目，在实体瘤中的应用。

'We are excited to advance IDE849, a potential first-in-class DLL3 TOP1 ADC, into a Phase 1 study in the U.S. DLL3 is upregulated in multiple solid tumor types, including small cell lung cancer (SCLC), neuroendocrine tumors (NETs), non-small cell lung cancer (NSCLC), melanoma, among other solid tumors, highlighting the potential to have a pipeline in a single asset.

“我们很高兴将IDE849，一种潜在的首创DLL3 TOP1 ADC，推进到美国的1期研究。DLL3在多种实体瘤类型中表达上调，包括小细胞肺癌（SCLC）、神经内分泌肿瘤（NETs）、非小细胞肺癌（NSCLC）、黑色素瘤以及其他实体瘤，这突显了单个药物可能拥有多适应症的潜力。

We look forward to the IDE849 clinical data update in SCLC at a medical conference in Q3 2025, including at multiple expansion doses,' said Yujiro S. Hata, President and Chief Executive Officer, IDEAYA Biosciences..

IDEAYA生物科学公司总裁兼首席执行官Yujiro S. Hata表示：“我们期待在2025年第三季度的医学会议上更新IDE849在小细胞肺癌（SCLC）中的临床数据，包括多个扩展剂量的数据。”

'IDE849 is a potential first-in-class DLL3 TOP1 ADC, a target antigen that has demonstrated preliminary monotherapy clinical validation in SCLC. In addition, IDE849 aligns with our strategy to develop rational combination therapies, particularly with our potential first-in-class Phase 1 PARG inhibitor IDE161, where we have generated preclinical combination data with TOP1-based ADCs that demonstrates combination synergy and enhanced durability,' said Dr. Darrin M.

“IDE849 是一种潜在的首创 DLL3 TOP1 ADC，其靶向抗原在小细胞肺癌（SCLC）中已显示出初步的单药临床验证。此外，IDE849 符合我们开发合理联合疗法的战略，特别是与我们潜在的首创一期 PARG 抑制剂 IDE161 联用，我们已经生成了基于 TOP1 的 ADC 联合疗法的临床前数据，证明了联合协同效应和增强的持久性，”Darrin M. 博士表示。

Beaupre, M.D., Ph.D., Chief Medical Officer, IDEAYA Biosciences..

博普雷，医学博士，哲学博士，首席医疗官，IDEAYA生物科学公司。

IDE849 is in an ongoing multi-site open label Phase 1 clinical trial for advanced solid tumors (NCT06443489) by Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Hengrui Pharma, SHA: 600276). In this ongoing Phase 1 study, IDE849 has reached therapeutic dose levels where multiple partial responses have been observed as of the data cut-off date of December 10, 2024.

IDE849 正在由江苏恒瑞医药股份有限公司（恒瑞医药，股票代码：600276）进行一项针对晚期实体瘤的多中心开放标签 I 期临床试验（NCT06443489）。在此正在进行的 I 期研究中，截至 2024 年 12 月 10 日的数据截止日期，IDE849 已达到治疗剂量水平，并观察到多个部分缓解。

As of the data cut-off date, treatment related adverse events (TRAEs) were predominantly Grade 1 or 2, and the Phase 1 dose escalation is ongoing with no reported drug-related discontinuations, and the maximum tolerated dose has not yet been reached. The most common TRAEs observed were white blood cell count decreased, anemia, neutrophil count decreased, platelet count decreased, and nausea. Hengrui Pharma is targeting to present clinical efficacy and safety data on IDE849 in over 40 SCLC patients from a multi-site open label Phase 1 trial, including from the dose escalation phase and at multiple expansion doses, at a medical conference in Q3 2025. .

截至数据截止日期，治疗相关的不良事件（TRAEs）主要为1级或2级，1期剂量递增试验正在进行中，尚未报告因药物相关的停药情况，且最大耐受剂量尚未达到。最常见的TRAEs包括白细胞计数减少、贫血、中性粒细胞计数减少、血小板计数减少和恶心。恒瑞制药计划在2025年第三季度的医学会议上展示来自多中心开放标签1期试验的IDE849在40多名小细胞肺癌患者中的临床疗效和安全性数据，包括剂量递增阶段及多个扩展剂量的数据。

In addition, IDEAYA is targeting to present preclinical combination mechanism and synergy efficacy data of IDE161/PARG with TOP1-payload based ADCs at a medical conference in the third quarter of 2025. We believe this potential first-in-class combination has the potential to enhance durability of IDEAYA's TOP1-payload based ADC pipeline, including IDE849 and IDE034 (B7H3/PTK7 Bispecific TOP1 ADC)..

此外，IDEAYA 计划在 2025 年第三季度的医学会议上展示 IDE161/PARG 与基于 TOP1 载体的 ADC 联合使用的临床前组合机制和协同疗效数据。我们相信，这种潜在的首创组合有可能增强 IDEAYA 基于 TOP1 载体的 ADC 管线的持久性，包括 IDE849 和 IDE034（B7H3/PTK7 双特异性 TOP1 ADC）。

DLL3 has been reported to be upregulated in multiple solid tumor types, including in SCLC, NETs, NSCLC, melanoma, among others. DLL3 has limited extracellular expression in normal tissues, making it a promising potential therapeutic target in these solid tumors, for which there remains significant unmet medical need..

DLL3在多种实体瘤类型中被报道为上调表达，包括小细胞肺癌（SCLC）、神经内分泌肿瘤（NETs）、非小细胞肺癌（NSCLC）、黑色素瘤等。DLL3在正常组织中的细胞外表达有限，这使其成为这些实体瘤中具有前景的潜在治疗靶点，而这些实体瘤仍存在显著未满足的医疗需求。

IDEAYA is targeting to evaluate IDE849 clinically in a multi-site global clinical trial as a monotherapy agent in SCLC, NETs and multiple DLL3 upregulated solid tumor types, and to evaluate IDE849 in a clinical combination with IDEAYA's potential first-in-class Phase 1 PARG inhibitor, IDE161, in the second half of 2025. .

IDEAYA 计划在多中心全球临床试验中将 IDE849 作为单药治疗剂，针对小细胞肺癌（SCLC）、神经内分泌肿瘤（NET）和多种 DLL3 上调的实体瘤类型进行临床评估，并计划在 2025 年下半年将 IDE849 与 IDEAYA 潜在的首创 Phase 1 PARG 抑制剂 IDE161 联合进行临床评估。

Based on the U.S. FDA guidance, IDEAYA will begin the Phase 1 study in the U.S. at a IDE849 starting dose that is equivalent to one of the expansion doses being evaluated in the ongoing Phase 1 study (NCT06443489) by partner Hengrui Pharma, where multiple confirmed partial responses have been observed by RECIST 1.1..

基于美国FDA的指导，IDEAYA将开始在美国进行1期研究，使用的IDE849起始剂量与合作伙伴恒瑞医药正在进行的1期研究（NCT06443489）中评估的扩展剂量之一相当，在该研究中已通过RECIST 1.1观察到多个确认的部分缓解。

About IDEAYA Biosciences

关于IDEAYA生物科学

IDEAYA is a precision medicine oncology company committed to the discovery and development of targeted therapeutics for patient populations selected using molecular diagnostics. IDEAYA's approach integrates capabilities in identifying and validating translational biomarkers with drug discovery to select patient populations most likely to benefit from its targeted therapies.

IDEAYA是一家精准医疗肿瘤公司，致力于利用分子诊断技术为特定患者群体发现和开发靶向治疗药物。IDEAYA的方法整合了识别和验证转化生物标志物的能力，并结合药物研发来选择最有可能从其靶向疗法中受益的患者群体。

IDEAYA is applying its research and drug discovery capabilities to synthetic lethality – which represents an emerging class of precision medicine targets..

IDEAYA正在将其研究和药物发现能力应用于合成致死性——这代表了一类新兴的精准医学靶点。