微芯生物与信达生物宣布合作开展晚期结直肠癌联合治疗的临床评估

2019-02-18 不详 网络

深圳微芯生物科技股份有限公司(微芯生物),是一家致力于原创新药的发现、研发、生产与销售全链条全生命周期的现代化生物医药企业。公司今天宣布与信达生产达成一项临床合作研究,评估微芯生物HDAC选择性抑制剂西达本胺与信达生物PD-1单抗信迪利单抗(IBI308),重组抗VEGF人源化单抗(IBI305)联合治疗晚期结直肠癌患者的安全性和耐受性。根据协议条款,微芯生物与信达生物将在实体瘤患者中评估三种药物

深圳微芯生物科技股份有限公司(微芯生物),是一家致力于原创新药的发现、研发、生产与销售全链条全生命周期的现代化生物医药企业。公司今天宣布与信达生产达成一项临床合作研究,评估微芯生物HDAC选择性抑制剂西达本胺与信达生物PD-1单抗信迪利单抗(IBI308),重组抗VEGF人源化单抗(IBI305)联合治疗晚期直肠癌患者的安全性和耐受性。

根据协议条款,微芯生物与信达生物将在实体瘤患者中评估三种药物的联合用药方案,双方近期将在中国开展患者的临床招募,以评估西达本胺与信迪利单抗(IBI308)重组抗VEGF人源化单抗(IBI305)在晚期直肠癌中的安全性以及有效性。


“晚期结直肠癌患者的治疗具有显著的未满足临床需求,不同靶向作用机制药物的合理组合应用,可能是提供这样临床需求的一个重要途径”,微芯生物执行副总裁宁志强博士表示,“我们很高兴能与信达生物联手,就免疫检查点抑制剂、血管生成抑制剂及表观遗传调控剂的联合应用,在这一适应症领域开展合作临床研究。“表观遗传异常是导致肿瘤患者相继产生免疫疗法耐药的主要原因之一,西达本胺作为一款国产创新型表观遗传调控剂在前期的实体瘤里展现出了可以改善耐药并增敏现有免疫疗法效果的作用”信达生物首席科学官薄科瑞表示,“我们很高兴能够和微芯生物一同探索西达本胺与PD-1抑制剂以及IBI305在结直肠癌中的临床联用,希望能在未来给国内的患者带来实质上的临床受益。”

关于西达本胺

西达本胺(商品名:爱谱沙® / epidaza®)是微芯生物自主研发的具全球专利保护的全新分子体、国际首个亚型选择性组蛋白去乙酰化酶(HDAC)口服抑制剂、属于选择性的表观遗传调控剂。西达本胺为苯酰胺类HDAC亚型选择性抑制剂,针对第I类HDAC中的1、2、3亚型和第IIb类的10亚型,具有对肿瘤发生发展相关的表观遗传异常的重新调控作用。西达本胺通过抑制相关HDAC亚型以增加染色质组蛋白的乙酰化水平来引发染色质重塑,并由此产生针对肿瘤发生的多条信号传递通路基因表达的改变(即表观遗传改变)。西达本胺直接抑制血液及淋巴系统肿瘤细胞周期并诱导细胞凋亡;诱导和激活自然杀伤细胞(NK)和抗原特异性细胞毒T细胞(CTL)介导的肿瘤杀伤作用,对机体抗肿瘤细胞免疫具有整体调节活性;西达本胺还通过表观遗传调控机制,诱导肿瘤干细胞分化、逆转肿瘤细胞的上皮间充质表型转化(EMT)等作用,进而在恢复耐药肿瘤细胞对药物的敏感性和抑制肿瘤转移、复发等方面发挥潜在作用。2014年12月,获国家食品药品监督管理总局(CFDA)批准上市,其首个适应症为复发及难治性的外周T细胞淋巴瘤,同时,单药及联合其他抗肿瘤药物针对其他血液肿瘤、实体瘤及HIV的临床研究正在美国、日本、中国及中国台湾等国家和地区同步开展。

关于信迪利单抗(Sintilimab)

信迪利单抗是一种全人源细胞程序性死亡-1(Programmed Cell Death 1,PD-1)单克隆抗体,可以与T细胞表面的PD-1受体结合,阻断其与配体PD-L1之间的结合,使T细胞和自身免疫发挥正常作用,进而将肿瘤细胞消灭。信迪利单抗是由信达生物和礼来制药集团在中国共同合作开发的PD-1单克隆抗体。国家药品监督管理局已于2018年4月16日正式受理由信达生物递交的信迪利单抗上市申请,并于4月23日将其列入优先审评品种,该药物申请的第一个适应症为复发/难治性经典型霍奇金淋巴瘤

关于IBI305

IBI305是全球畅销药物贝伐珠单抗的生物类似药,已进入临床III期研究。IBI305以VEGF为靶点,其作用机理是能够特异性结合VEGF,阻断VEGF与VEGF受体的结合,抑制VEGF诱导的血管新生和渗透性增加,从而阻止恶性肿瘤生长。临床研究包括在健康人群中进行的生物等效性研究以及在非小细胞肺癌患者中进行的随机、双盲、阳性药对照的多中心III期研究。

关于微芯生物

微芯生物是由资深留美归国团队创立于2001年的生物医药领域的领军企业,专长于原创小分子药物研发,具备完整的从药物作用靶点研究到临床候选药物开发及产业化的能力,拥有一支专长于原创新药研发的技术、管理和知识产权队伍。微芯生物以自主创建的“基于化学基因组学的集成式药物发现及早期评价平台”为其核心竞争力,以“原创、安全、优效”为其目标,致力于为患者提供可承受的创新机制治疗药物。在开发针对重大疾病、有全球专利保护及临床效果独特的创新小分子药物等方面均取得了多项突破性进展。公司也是国家重大科技专项的首批“创新药孵化基地”,独立承担了多项国家“863”和重大新药创制科技专项项目, 2013年荣获国家科学技术进步奖一等奖。2017年西达本胺获国家知识产权局颁发的发明专利金奖。

关于信达生物

“始于信,达于行”,开发出老百姓用得起的高质量生物药,是信达生物的理想和目标。信达生物成立于2011年,致力于开发、生产和销售用于治疗肿瘤等重大疾病的单克隆抗体新药。目前,公司已建成贯通生物创新药开发全周期的高质量技术平台,包括研发、药学开发及产业化、临床研究和营销等平台,已建立起了一条包括17个单克隆抗体新药品种的产品链,覆盖肿瘤、眼底病、自身免疫疾病、代谢疾病等四大疾病领域,4个品种进入临床III期研究,2个产品(信迪利单抗注射液和阿达木单抗生物注射液类似药)的上市申请被国家药监局受理并且其中信迪利单抗注射液进入优先审评。

信达生物已组建了一支具有国际先进水平的高端生物药开发、产业化人才团队,包括众多海归专家,并与美国礼来制药集团、Adimab等国际制药公司达成战略合作。信达生物希望和大家一起努力,提高中国生物制药产业的发展水平,以满足百姓用药可及性和人民对生命健康美好愿望的追求。

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