康方生物(09926.HK)自主研发双特异性抗体PD-1/VEGF(AK112)获NMPA临床试验批件
格隆汇8月11日丨康方生物-B(09926.HK)发布公告,公司自主研发的双特异性抗体PD-1/VEGF(AK112)获得中国国家药品监督管理局(NMPA)颁发的药物临床试验批件,将在中国进一步开展针对晚期实体瘤的1b期临床试验。AK112是公司继双抗PD-1/CTLA-4(AK104)之后第二款全球首创并进入临床开发阶段的双特异性抗体药物,已经于2019年10月在澳洲开展一期临床研究。
近来PD-1/PD-L1抗体与VEGF阻断剂的联合疗法频繁在包括肺癌、肾癌和肝癌等多种肿瘤适应症中显示出强大的疗效,甚至获得美国食品药品监督管理局(FDA)批准。这也预示着针对PD-1/PD-L1和VEGF双靶点的双特异性抗体将有可能有较高的成功概率。
AK112是公司自主研发,全球行业内首个进入临床研究的PD-1/VEGF双特异性抗体。AK112是基于公司独特的TETRABODY技术设计,可阻断PD-1与PD-L1和PD-L2的结合,并同时阻断VEGF与VEGF受体的结合。PD-1抗体与VEGF阻断剂的联合疗法已在多种瘤种(如肾细胞癌、非小细胞肺癌和肝细胞癌)中显示出强大的疗效。鉴于VEGF和PD-1在肿瘤微环境中的共表达,与联合疗法相比,AK112作为单一药物同时阻断这两个靶点,可能会更有效地阻断这两个通路从而增强抗肿瘤活性。
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