诺纳生物合作伙伴辉瑞在2025 AACR年会上公布基于TOP1i靶向人间皮素ADC疗法的临床前数据

医药魔方2025-04-28

诺纳生物，一家致力于前沿技术创新，并为合作伙伴提供涵盖靶点验证和新一代生物大分子药物从发现至临床前研发等Idea to IND（I to ITM）完整服务的国际化创新生物技术公司，今日宣布其合作伙伴辉瑞在2025年美国癌症研究协会（AACR）年会上公布了同类首创基于拓扑异构酶1抑制剂（TOP1i）的靶向人间皮素（MSLN）抗体偶联药物（ADC）PF-08052666（HBM9033；SGN-...

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cancersPF-08052666（HBM9033），一款同类首创、基于拓扑异构酶1抑制剂的靶向人间皮素ADC疗法，在卵巢癌、肺癌及结直肠癌临床前模型中显示出强大的抗肿瘤活性摘要编号：324壁报编号：16报告场次：Antireceptors and Other Biological Therapeutic Agents报告日期：2025年4月27日PF-08052666在分子设计上采用了新型抗体、差异化连接子-载荷以及较高的药物抗体比（DAR），旨在解决以往靶向MSLN ADC疗法的局限性。该ADC由全人源IgG1单克隆抗体与基于喜树碱的强效TOP1i载荷，通过可被蛋白酶裂解的连接子连接而成，DAR均值达到8。本次公布的主要临床前研究结果包括：体外研究表明，PF-08052666通过向MSLN阳性细胞输送有效载荷，直接发挥细胞杀伤作用，并通过旁观者效应对共培养的MSLN阴性细胞产生杀伤活性。即使在生理学浓度可溶性MSLN存在的情况下，PF-08052666仍具备细胞杀伤能力。体内研究数据显示，在涵盖卵巢癌、肺癌和结直肠癌等多种肿瘤细胞系和患者来源的异种移植模型中，PF-08052666的表现均优于基于DM4的抗MSLN基准ADC。在由MSLN阳性和MSLN阴性混合细胞组成的异源异种移植模型中，PF-08052666同样表现出优于基于DM4的抗MSLN基准ADC的疗效，表明MesoC2的新型连接子-载荷具有更为显著的旁观者效应。上述极具前景的临床前研究结果，为PF-08052666在晚期实体瘤患者中开展首次人体I期临床试验提供了有力支持。目前，该试验（NCT06466187）正在进行受试者招募工作。诺纳生物董事长王劲松博士表示:辉瑞在2025 AACR年会上公布的PF-08052666临床前数据，充分彰显了诺纳生物技术平台的强大实力，以及我们对推进变革性疗法的坚定承诺。凭借行业领先的技术平台，诺纳生物将持续推动行业创新，加速新一代生物疗法的开发。我们期待与辉瑞进一步深化合作，携手加速关键领域的突破性研发进展，以满足迫切且尚未解决的医疗需求。关于PF-08052666（HBM9033）PF-08052666是一款特异性靶向人间皮素（MSLN）的抗体偶联药物（ADC），该肿瘤相关抗原在多种实体瘤中上调。PF-08052666中的全人源单克隆抗体来源于Harbour Mice®平台，具有良好的特性，可保持与膜结合型MSLN的强结合和内化并减少与可溶性MSLN的结合。独特的抗体设计使其在各种具有不同MSLN表达水平的临床前肿瘤模型研究中展现出卓越的疗效，从而使PF-08052666成为一款潜在的全球同类最佳疗法。关于诺纳生物诺纳生物是一家国际化的创新生物技术公司，作为和铂医药全资子公司，致力于前沿技术创新，并为合作伙伴提供涵盖靶点验证和多元化形态药物分子从发现至临床前研发等I to ITM（Idea to IND）完整服务。运用整合创新的技术平台及全球领先的科学家团队，公司提供涵盖抗原制备、动物免疫、单B细胞筛选、抗体开发与工程、成药性评估和药理评估的完整抗体发现解决方案。Harbour Mice®可生成经典抗体（H2L2）和仅重链（HCAb）形式的全人源单克隆抗体，与单B细胞克隆筛选平台相互协作从而优化抗体发现效率。诺纳生物聚焦全球专利技术平台，赋能全球生物医药源头创新，助推全球新一代抗体药物开发。Copyright © 2025 PHARMCUBE. 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