石药集团与美国Flame Biosciences达成超6亿美元合作协议,推进新型双特异性抗体全球化

2021-08-17 JACKZHAO MedSci原创

石药集团公告

石药集团公告

8月17日,石药集团发布公告称,该公司附属公司NovaRock Biotherapeutics Limited(NovaRock)已与Flame Biosciences, Inc. (Flame Biosciences)订立策略合作及许可协议(该协议)。

根据该协议的条款,NovaRock将授予Flame Biosciences在大中华(包括中国大陆、中国香港、中国澳门及中国台湾)以外地区开发、制造及商业化其全人源抗Claudin18.2单克隆抗体 (NBL-015)的独家权利。NovaRock亦将利用其NovaTE双特异性抗体技术平台与Flame Biosciences合作发现及临床前开发两款新型双特异性抗体(连同NBL-015,统称许可产品),所有开支由Flame Biosciences承担,并其后授予Flame Biosciences在区域开发、制造及商业化该两款新型双特异性抗体的独家权利。

Claudin18.2是claudin家族的成员,属于紧密连接蛋白类。它在正常组织中的表达仅限于胃细胞谱系和短寿命分化的上皮细胞,而它在多种癌症类型中表达,包括胰腺癌、胃癌、食道癌、肺癌和卵巢癌。肿瘤和正常组织之间claudin18.2的差异表达模式使其有希望成为治疗这些癌症药物靶标,尤其是胰腺和胃食管肿瘤。据悉,NBL-015是一种全人源抗Claudin 18.2单克隆抗体,并经过蛋白工程优化,具有增强的 ADCC、CDC和ADCP效应。

此前发表在Cancer research摘要称,使用NovaRock 的专有抗体发现和开发平台成功发现和优化了下一代抗 claudin18.2 mAb,NBL-015。 NBL-015 在体外和体内表现出强大的抗肿瘤活性。临床前体外细胞杀伤实验和肿瘤小鼠模型中显示NBL-015较同类药物具有免疫原性低、安全性高、亲和力强及抗肿瘤活性高的显著优势,有望成为治疗胰腺癌胃癌的同类最佳靶向药物。NBL-015已获美国食品药品监督管理局(FDA)颁发针对治疗胰腺癌和胃癌(包括食道胃结合部癌)的孤儿药资格认定,其试验性新药(IND)申请亦已于2021年5月获美国FDA批准。

近年来,胰腺癌的发病率呈上升趋势,其死亡率居恶性肿瘤的第3位。过去十年,胰腺癌的诊治取得了长足进步,然而国内不同地区水平参差不齐,其诊治现状依然严峻。胰腺癌导致每年全球超过43万人死亡,是恶性程度最高的肿瘤之一。美国癌症协会2019年发布的数据显示,其1年整体生存率仅约24%,5年整体生存率约9%,占美国肿瘤相关死亡的第4位。胰腺癌的诊断和治疗方法十分有限,90%的患者被诊断时已是局部晚期或转移癌,转移后的五年中位生存率不到6%,而目前胰腺癌的治疗方法局限于常规化疗和手术切除,属于高度未被满足的临床需求。

蔡洁等对2005-2015年中国胰腺癌发病与死亡趋势分析发现,2005-2015年中国胰腺癌粗发病率及粗死亡率变化趋势基本一致,中国胰腺癌的发病率和死亡率稳中有升。2005-2015年胰腺癌的总体发病中标率平均每年上升2.78%,总体死亡中标率平均每年上升2.24%。发病率以农村男性中标率变化最快,平均每年上升3.74%,死亡率以城市男性中标率变化最快,平均每年上升3.57%。发病率及死亡率的年龄效应总体随年龄增长而上升,在70~80岁时效应最大。

该公告还称,NovaRock将收取750万美元的首付款,并有权在达成开发里程碑事件的条件下收取最多1.725亿美元的开发里程碑款项。NovaRock亦有权在达成销售里程碑事件的条件下收取最多4.6亿美元的销售里程碑款项,及按许可产品于区域的销售净额的若干百分比收取提成。

NovaTE是一个新颖的肿瘤抗原及CD-137双抗技术平台,旨在于肿瘤微环境中选择性地激活具抗原经历的T细胞。其专利支架可最大化肿瘤细胞参与及T细胞激活,同时尽量减低发生系统性不良事件的可能性。使用NovaTE开发的抗体在临床前研究中显示优异的疗效及安全性。此外,独特的双特异性抗体结构提供卓越的稳定性及可制造性。

Flame Biosciences是一间总部设于美国的创新制药公司,该公司集中于癌症及其他炎症的变革性疗法的研发及商业化。与Flame Biosciences的策略合作不单可加快该集团的创新药管线于全球市场的临床开发,亦标志着该集团在推进其国际化策略方面取得重大进展。

 

参考资料:

  1. 石药集团:自愿公告 - 与FLAME BIOSCIENCES订立策略合作及许可协议
  2. 2005-2015年中国胰腺癌发病与死亡趋势分析
 

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attachment=null, authenticateStatus=null, createdAvatar=, createdBy=44985284187, createdName=1484c916m65暂无昵称, createdTime=Wed Aug 18 00:01:28 CST 2021, time=2021-08-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1008856, encodeId=525710088567b, content=期待NBL-015美好的临床前景, beContent=null, objectType=article, channel=null, level=null, likeNumber=53, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=bc5c5467719, createdName=医海拾贝, createdTime=Tue Aug 17 22:44:30 CST 2021, time=2021-08-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1008844, encodeId=7d261008844e4, content=石药集团, beContent=null, objectType=article, channel=null, level=null, likeNumber=54, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, 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    2022-03-01 sunylz
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    2021-08-20 研发小兵

    双特异性抗体是热点,但是也不一定都有效!

    0

  6. 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    2021-08-19 jichang
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  8. 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attachment=null, authenticateStatus=null, createdAvatar=, createdBy=44985284187, createdName=1484c916m65暂无昵称, createdTime=Wed Aug 18 00:01:28 CST 2021, time=2021-08-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1008856, encodeId=525710088567b, content=期待NBL-015美好的临床前景, beContent=null, objectType=article, channel=null, level=null, likeNumber=53, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=bc5c5467719, createdName=医海拾贝, createdTime=Tue Aug 17 22:44:30 CST 2021, time=2021-08-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1008844, encodeId=7d261008844e4, content=石药集团, beContent=null, objectType=article, channel=null, level=null, likeNumber=54, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20210313/9df56058b3964a8cac82563f95f0389d/c1b478592e8e4463bef44d32712e98fd.jpg, createdBy=ea905324251, createdName=SR~young海东, createdTime=Tue Aug 17 22:17:16 CST 2021, time=2021-08-17, status=1, ipAttribution=)]
    2021-08-18 1484c916m65暂无昵称

    期待期待

    0

  9. 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    2021-08-17 医海拾贝

    期待NBL-015美好的临床前景

    0

  10. 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    2021-08-17 SR~young海东

    石药集团

    0

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