Arvinas靶向雌激素受体的蛋白质降解剂ARV-471治疗乳腺癌,其IND申请获FDA授权

2019-06-26 不详 MedSci原创

Arvinas宣布其靶向雌激素受体(ER)的蛋白质降解剂ARV-471治疗局部晚期或转移性ER阳性/ HER2阴性乳腺癌的新药研究申请(IND),已经获得美国食品和药物管理局(FDA)的授权。Arvinas预计将在2019年第三季度开始ARV-471的1期临床试验。

Arvinas宣布其靶向雌激素受体(ER)的蛋白质降解剂ARV-471治疗局部晚期或转移性ER阳性/ HER2阴性乳腺癌的新药研究申请(IND),已经获得美国食品和药物管理局(FDA)的授权。Arvinas预计将在2019年第三季度开始ARV-471的1期临床试验。

在美国,乳腺癌是第二大常见癌症,也是女性癌症死亡的第二大原因。美国癌症协会估计,在2019年,美国将有大约268000名女性被诊断患有浸润性乳腺癌。转移性乳腺癌占新诊断病例的6%。大约80%的新诊断乳腺癌是ER阳性,许多患者随着时间的推移对当前的治疗方案产生抗性。

ARV-471是一种基于PROTAC技术专门设计为靶向降解ER蛋白的降解剂。第1阶段试验将评估ARV-471的安全性、耐受性和药代动力学,还将包括抗肿瘤活性和药效学的测量作为次要终点。

临床前研究中,ARV-471在肿瘤细胞中表现出近乎完全的ER降解,当在多个ER驱动的异种移植模型中作为单一药物给药时可诱导强烈的肿瘤抑制作用。Arvinas公司认为,ARV-471很有可能为患者带来有意义的临床益处。

原始出处:


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    2020-05-09 yibei
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    2019-10-20 楚秀娟
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    2019-06-28 xiaogang319
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