君实生物与捷思英达达成战略合作:开展PD-1单抗联合ERK抑制剂JSI-1187临床研究

2020-09-08 医药魔方 医药魔方

实生物,一家以创新为驱动致力于创新疗法的发现、开发和商业化的生物制药公司,与捷思英达,一家基于最新药物作用机制(MOA)致力于国际首创抗癌新药研发的生物医药企业,今日宣布双方达成战略合作,共同开展特瑞

实生物,一家以创新为驱动致力于创新疗法的发现、开发和商业化的生物制药公司,与捷思英达,一家基于最新药物作用机制(MOA)致力于国际首创抗癌新药研发的生物医药企业,今日宣布双方达成战略合作,共同开展特瑞普利单抗(抗PD-1单抗,商品名:拓益?)联合JSI-1187(ERK激酶抑制剂)用于治疗晚期黑色素瘤、直结肠癌以及其它经双方同意的适应证的临床试验。

君实生物首席执行官李宁博士表示:「捷思英达是一家充满创新活力、具有国际竞争力的小分子抗癌新药研发企业。在不到3年的时间里,就成功把主要产品ERK激酶抑制剂JSI-1187推进至临床I期阶段,体现出捷思英达极高的研发质量和效率。研究显示,ERK抑制剂联合PD-1免疫药物治疗MAPK突变肿瘤颇具前景。因此,我们也希望基于转化医学研究,共同探索这两项新药的联合疗法,为癌症病人提供更有效、更精准的治疗选择。」

捷思英达首席执行官张劲涛博士表示:「君实生物是在肿瘤免疫领域创新药物研发和产业化的领导者,我们很高兴能和君实生物一起开展ERK抑制剂与PD-1单抗联合用药的临床研究。我们期待JSI-1187和特瑞普利单抗联用能在未来给癌症患者带来更好的疗效。」

ERK是经典丝裂原活化蛋白激酶(MAPK)信号通路RAS-RAF-MEK-ERK中的下游蛋白激酶。RAS-RAF-MEK-ERK级联的MAPK信号在癌症生长和增殖中起着至关重要的作用,而且是多种类型实体肿瘤的常见突变,比如KRAS突变常见于胰腺癌(90%)、结直肠癌(30%-50%)、肺癌(25%-30%)、卵巢癌(15%-39%)和子宫内膜(18%),NRAS突变和BRAF V600突变在黑色素瘤中可分别达到20%和50%。

目前,已经有多款针对MAPK上游激酶的抑制剂上市,用于治疗黑色素瘤、非小细胞肺癌、甲状腺癌等,比如BRAF抑制剂维莫非尼,达拉非尼,MEK抑制剂曲美替尼、考比替尼等,证明了通过抑制MAPK这条信号通路对抗肿瘤的有效性。虽然靶向抑制「BRAF+MEK」的联合疗法(比如达拉非尼+曲美替尼)在黑色素瘤和其他癌症中显示出比单药具有更显着的药效,但大多数患者最终都会产生耐药性和疾病进展。在已发现的耐药机制中,ERK激酶的重新激活是非常关键的一个因素。

PD-(L)1单抗可以阻断肿瘤细胞诱导的人体免疫细胞T细胞「休眠」,部分恢复T细胞杀伤肿瘤细胞的功能,从而激活人体自身的免疫系统来对抗肿瘤细胞,达到长期控制或消除肿瘤的效果。有研究显示,MAPK通路的抑制可能会增加肿瘤抗原呈递,促进T细胞进入肿瘤,以及增加肿瘤细胞PD-L1表达。因此,免疫与靶向PD-(L)1和MAPK的联合疗法是非常适合MAPK突变肿瘤的一个治疗策略。

「PD-(L)1+MAPK」免疫与靶向组合疗法在近期也取得了多项关键进展。2020年7月,美国FDA批准了PD-L1单抗+BRAF抑制剂+MEK抑制剂三药联合治疗BRAF V600突变阳性的晚期黑色素瘤。最近,也有跨国药企启动了PD-1单抗+BRAF抑制剂+ERK抑制剂三药联治疗BRAF V600突变直结肠癌的临床试验。由此可见PD-(L)1单抗和MAPK通路抑制剂的联合疗法具有较广阔的前景。

特瑞普利单抗(拓益?)是君实生物自主研发、中国首个获批上市的国产抗PD-1单抗,目前已在全球开展了30多项单药和联合治疗多种类型肿瘤的临床试验。其首个上市适应症为既往接受全身系统治疗失败的不可切除或转移性黑色素瘤。JSI-1187是捷思英达自主研发的选择性ERK1/2小分子抑制剂,在临床前模型中对MAPK通路突变的肿瘤具有高度抑制性,目前正在美国进行I期临床试验,覆盖BRAF V600突变晚期恶性实体瘤,以及包括RAS在内MAPK突变晚期恶性实体瘤等适应症。特瑞普利单抗+JSI-1187的联合疗法有望给包括黑色素瘤在内的多种类型肿瘤患者带来更佳的治疗选择。

关于拓益?(特瑞普利单抗注射液)

拓益?(特瑞普利单抗注射液)作为我国批准上市的首个国产以PD-1为靶点的单抗药物,获得国家科技重大专项项目支持。本品获批的第一个适应症为既往接受全身系统治疗失败的不可切除或转移性黑色素瘤的治疗。本品的上市批准对解决我国肿瘤患者临床用药选择具有积极意义。

拓益?自2016年初开始临床研发,至今已在全球开展了30多项临床研究,积极探索本品在鼻咽癌、尿路上皮癌、肺癌、胃癌、食管癌、肝癌、乳腺癌、肾癌等适应证的疗效,与国内外领先创新药企的联合疗法合作也在进行当中,期待让更多中国以及其它国家的患者获得国际先进水平的肿瘤免疫治疗。

关于JSI-1187

JSI-1187是选择性ERK1/2小分子抑制剂,在临床前模型中对MAPK 通路突变的肿瘤具有高度抑制性。目前,JSI-1187正在美国进行一期临床试验,评估JSI-1187在携带MAPK突变的复发、难治性实体肿瘤患者中的安全性、耐受性、药代动力学、药理动力学和临床药效。该研究将包括三个组成部分:(1)JSI-1187单药的剂量爬坡阶段,用于实体肿瘤患者;(2)JSI-1187与BRAF抑制剂达拉非尼联用的剂量爬坡;和(3)对携带特定突变的肿瘤患者的扩展组试验。

关于君实生物

君实生物于2012年12月由毕业于中美两国知名学府、具有丰富跨国科技成果转化及产业经验的团队创办。

君实生物以开发治疗性抗体为主,专注于创新单克隆抗体药物和其他治疗性蛋白药物的研发与产业化,具有丰富的在研产品管线,包括19个创新药,2个生物类似物,覆盖五大治疗领域,包括恶性肿瘤、自身免疫系统疾病、慢性代谢类疾病、神经系统类疾病以及抗感染疾病。君实生物是国内首家获得抗PD-1单克隆抗体NMPA上市批准、抗PCSK9单克隆抗体NMPA临床申请批准的中国公司,并取得了全球首个治疗肿瘤抗BTLA阻断抗体在中国NMPA和美国FDA的临床申请批准。今年,君实生物还与国内科研机构携手抗疫,共同开发的JS016已作为国内首个抗新冠病毒单克隆中和抗体进入临床试验,用本土创新为中国和世界疾病预防控制贡献力量。目前君实生物在全球拥有近两千名员工,分布在美国旧金山和马里兰,中国上海、苏州、北京和广州。

关于捷思英达

捷思英达是一家临床阶段的小分子抗癌新药研发企业,公司位于上海张江科学城国际医学园区,有包括动物房在内的新药研发技术平台,在美国波士顿设有负责临床开发的子公司。捷思英达及时应用国际知名临床专家最新发现的药物作用机制,致力于具有国际首创新药潜力的原创抗癌新药研发,解决国内外肿瘤患者高未满足的临床需求。公司主要管线产品具有差异化和国际竞争力,中美同步开发。目前有Aurora A激酶抑制剂VIC-1911,ERK1/2激酶抑制剂JSI-1187和MEK激酶抑制剂E6201等产品处于临床1期阶段,由国际最权威的医生主持临床试验。

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    2021-06-24 chenlianhui
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    2021-01-06 jklm09
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  4. [GetPortalCommentsPageByObjectIdResponse(id=1752136, encodeId=15401e5213692, content=<a href='/topic/show?id=735669505d' target=_blank style='color:#2F92EE;'>#ERK#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=34, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=6950, encryptionId=735669505d, topicName=ERK)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=5e8a36466835, createdName=chenlianhui, createdTime=Thu Jun 24 19:17:25 CST 2021, time=2021-06-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1852485, encodeId=1e4218524851d, content=<a href='/topic/show?id=f0a254918f0' target=_blank style='color:#2F92EE;'>#抑制剂#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=54918, encryptionId=f0a254918f0, topicName=抑制剂)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=44a360, createdName=jklm09, createdTime=Wed Jan 06 20:17:25 CST 2021, time=2021-01-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1364902, encodeId=bfad136490202, content=<a href='/topic/show?id=da511390508' target=_blank style='color:#2F92EE;'>#PD-1单抗#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13905, encryptionId=da511390508, topicName=PD-1单抗)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8fc0211, createdName=doctor-chen9582, createdTime=Wed Sep 09 15:17:25 CST 2020, time=2020-09-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1478264, encodeId=c60514e8264db, content=<a href='/topic/show?id=5e295415950' target=_blank style='color:#2F92EE;'>#战略合作#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=54159, encryptionId=5e295415950, topicName=战略合作)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=30bd35, createdName=一叶知秋, createdTime=Wed Sep 09 15:17:25 CST 2020, time=2020-09-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=883624, encodeId=3ca488362413, content=<a href='/topic/show?id=daf52906537' target=_blank style='color:#2F92EE;'>#免疫治疗#</a>与特定靶点结合不一定有好的效果。最好加TMB或者MSI high结合评估, beContent=null, objectType=article, channel=null, level=null, likeNumber=172, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=29065, encryptionId=daf52906537, topicName=免疫治疗)], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20220519/c2ab253484ee4527a2d4e9589a4821ac/45de9bf494a54becb2ea4369c9d11e85.jpg, createdBy=7a3710, createdName=lovetcm, createdTime=Tue Sep 08 14:55:47 CST 2020, time=2020-09-08, status=1, ipAttribution=)]
  5. [GetPortalCommentsPageByObjectIdResponse(id=1752136, encodeId=15401e5213692, content=<a href='/topic/show?id=735669505d' target=_blank style='color:#2F92EE;'>#ERK#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=34, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=6950, encryptionId=735669505d, topicName=ERK)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=5e8a36466835, createdName=chenlianhui, createdTime=Thu Jun 24 19:17:25 CST 2021, time=2021-06-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1852485, encodeId=1e4218524851d, content=<a href='/topic/show?id=f0a254918f0' target=_blank style='color:#2F92EE;'>#抑制剂#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=54918, encryptionId=f0a254918f0, topicName=抑制剂)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=44a360, createdName=jklm09, createdTime=Wed Jan 06 20:17:25 CST 2021, time=2021-01-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1364902, encodeId=bfad136490202, content=<a href='/topic/show?id=da511390508' target=_blank style='color:#2F92EE;'>#PD-1单抗#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13905, encryptionId=da511390508, topicName=PD-1单抗)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8fc0211, createdName=doctor-chen9582, createdTime=Wed Sep 09 15:17:25 CST 2020, time=2020-09-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1478264, encodeId=c60514e8264db, content=<a href='/topic/show?id=5e295415950' target=_blank style='color:#2F92EE;'>#战略合作#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=54159, encryptionId=5e295415950, topicName=战略合作)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=30bd35, createdName=一叶知秋, createdTime=Wed Sep 09 15:17:25 CST 2020, time=2020-09-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=883624, encodeId=3ca488362413, content=<a href='/topic/show?id=daf52906537' target=_blank style='color:#2F92EE;'>#免疫治疗#</a>与特定靶点结合不一定有好的效果。最好加TMB或者MSI high结合评估, beContent=null, objectType=article, channel=null, level=null, likeNumber=172, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=29065, encryptionId=daf52906537, topicName=免疫治疗)], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20220519/c2ab253484ee4527a2d4e9589a4821ac/45de9bf494a54becb2ea4369c9d11e85.jpg, createdBy=7a3710, createdName=lovetcm, createdTime=Tue Sep 08 14:55:47 CST 2020, time=2020-09-08, status=1, ipAttribution=)]
    2020-09-08 lovetcm

    #免疫治疗#与特定靶点结合不一定有好的效果。最好加TMB或者MSI high结合评估

    0

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