康宁杰瑞(09966.HK)将发布KN046及KN026的研究进展
格隆汇5月7日丨康宁杰瑞(09966.HK)发布公告，将于2021年美国临床肿瘤学会年会以摘要及海报呈列发布KN046（一种重组人源化PD-L1/CTLA-4双特异性抗体）及KN026（一种基于Fc的抗HER2双特异性抗体）的研究进展，美国临床肿瘤学会为医生及肿瘤学专业人士关爱癌症患者的世界领先专业机构。摘要将于2021年5月19日下午五时正（东部时间）及电子海报呈列材料将于2021年6月4日下午九时正于公司网站http://www.alphamabonc.com相应公布。
据悉，KN046是集团自主研发的全球首创PD-L1/CTLA-4双特异性抗体。KN046同时靶向两个临床验证的免疫检查点，PD-L1及CTLA-4。目前，KN046在澳大利亚和中国已开展覆盖十多种肿瘤（包括非小细胞肺癌、三阴乳腺癌、食管鳞状细胞癌、肝细胞癌及胰腺癌）的约20项不同阶段临床试验。该等临床试验结果初步显示出KN046具有良好的安全性和疗效。基于在中国及澳大利亚取得的临床试验结果，美国食品药品监督管理局已批准集团于美国直接进入KN046的II期临床试验，并已就KN046授予孤儿药资格，用于治疗胸腺上皮肿瘤。目前，旨在评估KN046联合含铂化疗对局部晚期不可切除或转移性鳞状非小细胞肺癌患者的疗效及安全性的III期临床试验已在中国启动。
KN046的临床前及临床试验结果展现出良好的疗效，并表明可显著减少对人体外周系统可能产生的毒副作用。公司认为，KN046有望成为突破性肿瘤免疫特效药。
KN026（一种基于Fc的抗HER2的BsAb）可能为全球新一代HER2靶向疗法，可同时结合两种不同的经临床验证的HER2表位，导致(i)双重阻断HER2相关信号通路、(ii)增强与HER2受体的结合、(iii)减少细胞表面的HER2蛋白及(iv)增强对肿瘤的杀伤效果。该等结合机制可能使KN026表现出卓越的肿瘤抑制作用。
集团的KN026分别于2018年3月及2018年10月获得了国家药监局的伞式IND批准附注 ，及美国食品药品监督管理局的IND批准。目前，KN026正在中国进行数项I/II期临床试验，并在美国进行一项I期临床试验。KN026已在晚期乳腺癌患者中表现出良好的初步疗效。
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