基石药业-B(02616.HK)肿瘤治疗抑制剂CS3002已在澳洲完成I期试验备案相关研究即将开展
格隆汇8月22日丨基石药业-B(02616.HK)公布,公司近日收到澳洲人类研究伦理委员会就CS3002I期临床试验签发的伦理许可。于2019年8日14日,公司就该试验提交的电子临床试验通知(eCTN)获澳大利亚药品管理局(TGA)确认。该临床试验是一项开放性、多剂量、剂量递增与剂量扩展的I期临床研究,旨在评价CS3002在晚期实体瘤患者中的安全性、耐受性、药代动力学及抗肿瘤疗效。
CS3002是由基石药业开发的细胞周期蛋白依赖性激酶4和6(CDK4/6)的选择性抑制剂。通过特异性抑制CDK4/6以达到诱导肿瘤细胞的细胞周期停滞的目的,CS3002已显示出在联合内分泌治疗或免疫检查点抑制剂治疗中对多种实体瘤的广阔应用前景。目前,已有三种CDK4/6抑制剂获得美国食品药品监督管理局(FDA)的批准。但在中国,仅有palbociclib一款CDK4/6抑制剂获批,用于联合芳香化酶抑制剂作为绝经后女性激素受体阳性(HR+)、人表皮生长因数受体2阴性(HER2-)的晚期或转移性乳腺癌的一线内分泌治疗。
临床前的研究表明,CS3002具有与palbociclib相当的体内外活性。在小鼠模型中,与单药治疗相比,CS3002联合PD-1单抗或内分泌治疗均显示出了良好的抑制肿瘤生长的作用。此外,CS3002在安全性及耐受性上也显示出潜在优势。
基石药业董事长、执行董事兼首席执行官江宁军博士表示:目前,全球已有多个CDK4/6抑制剂获批或处于临床研发阶段。然而,中国患者可选择的同类药物非常有限,且尚无由国内自主研发的CDK4/6抑制剂获批。很高兴看到CS3002即将在澳洲开展I期试验。未来我们也将尽快推进其在中国临床试验的申请,并积极探索CS3002在更多肿瘤类型及不同联合治疗中的应用。期待CS3002能成为惠及中国患者的有效的治疗新手段。
基石药业首席科学官王辛中博士表示:CDK4/6在多种肿瘤中存在异常活化,这表明CS3002在乳腺癌和其他多种实体瘤的治疗中都具有应用潜力。最近的研究发现,CDK4/6抑制剂不仅能够诱导肿瘤细胞周期停滞,而且能增强抗肿瘤免疫以及调节肿瘤微环境。这些发现为新的癌症治疗策略提供了基础,即CDK4/6抑制剂与免疫疗法联合治疗。公司期待CS3002在澳洲的临床研究进展顺利。
据悉,CS3002是基石药业开发的具备良好耐受性和高度选择性的新一代CDK4/6抑制剂。CDK4/6抑制剂属于周期蛋白依赖性激酶,在调控细胞周期从第一生长期(G1期)到合成期(S期)起着至关重要的作用。细胞增殖信号启动后,D型细胞周期蛋白与CDK4/6结合。D型细胞周期蛋白与CDK4/6的复合物进而使下游视网膜母细胞瘤(Rb)蛋白磷酸化,产生CDK4/6通路中的异常增殖信号,推进细胞周期由G1期向S期转化。
CDK4/6异常活化是大多数癌症的共同特征。CDK4/6抑制剂能够抑制CDK4/6的活性和Rb蛋白磷酸化,阻止细胞周期从G1期进入S期,从而达到抑制肿瘤细胞生长的目的。肿瘤细胞中普遍存在的cyclinD–CDK4/6–INK4–Rb通路异常,预示着CDK4/6抑制剂在增强肿瘤免疫方面的潜在作用,以及CDK4/6抑制剂在多种实体瘤治疗及肿瘤免疫联合治疗中具有广阔的应用前景。
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