Immunocore的tebentafusp治疗转移性葡萄膜黑色素瘤被FDA授予快速通道指定

2019-04-04 不详 MedSci原创

T细胞受体(TCR)生物技术公司Immunocore的候选药物tebentafusp(IMCgp100)获得FDA快速通道指定治疗转移性葡萄膜黑色素瘤(mUM)。

T细胞受体(TCR)生物技术公司Immunocore的候选药物tebentafusp(IMCgp100)获得FDA快速通道指定治疗转移性葡萄膜黑色素瘤(mUM)。

该指定是基于IMCgp100-202试验,该试验是与达卡巴嗪、CTLA-4单抗ipilimumab或PD-1单抗pembrolizumab相比的药物随机研究。

Immunocore公司的核心技术是ImmTACs(抗肿瘤免疫激动单克隆T细胞受体),这是一种新型的双特异性生物大分子,由工程化改造的T细胞受体(TCR)以及抗CD3的scFv组成,其中:改造后的TCR能特异性结合肿瘤细胞表面的抗原肽-人类白细胞抗原复合物(pHLA),抗CD3的scFv则能够吸引、招募T细胞至肿瘤细胞周围并激活T细胞发挥肿瘤杀伤作用。

Tebentafusp是临床推进最快的一种ImmTAC,旨在特异性靶向黑色素瘤相关抗原gp100并使T细胞直接针对癌细胞产生强效且特异性的抗肿瘤作用。Tebentafusp已获得FDA颁发的黑色素孤儿药名称和英国早期药物计划下的Promising Innovative Medicine认证。

Immunocore研发负责人David Berman评论道:"对于转移性葡萄膜黑色素瘤患者,预后很差,几十年来没有任何改变。我们的目标是测试tebentafusp是否可以延长这些患者的生存期,很高兴tebentafusp被授予Fast Track Designation。"

FDA的快速通道计划旨在促进药物的开发,加快药物审查,以治疗严重疾病并满足未满足的医疗需求。

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createdAvatar=null, createdBy=1c6123209017, createdName=yeye5224620, createdTime=Thu Dec 05 07:19:00 CST 2019, time=2019-12-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1993729, encodeId=15e31993e29d1, content=<a href='/topic/show?id=51c0e3164b' target=_blank style='color:#2F92EE;'>#FDA授予快速通道指定#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7316, encryptionId=51c0e3164b, topicName=FDA授予快速通道指定)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=66962500501, createdName=yige2004, createdTime=Sat Jun 15 08:19:00 CST 2019, time=2019-06-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1680606, encodeId=acbf1680606fe, content=<a href='/topic/show?id=9e5c86e0712' target=_blank style='color:#2F92EE;'>#色素#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, 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style='color:#2F92EE;'>#葡萄膜黑色素瘤#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=88285, encryptionId=588988285e6, topicName=葡萄膜黑色素瘤)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a12645, createdName=智智灵药, createdTime=Sat Apr 06 11:19:00 CST 2019, time=2019-04-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1449882, encodeId=650914498827a, content=<a href='/topic/show?id=775e52084ac' target=_blank style='color:#2F92EE;'>#快速通道指定#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=52084, encryptionId=775e52084ac, topicName=快速通道指定)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=b88a5514460, createdName=qidongfanjian, createdTime=Sat Apr 06 11:19:00 CST 2019, time=2019-04-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1558960, encodeId=4b04155896011, content=<a href='/topic/show?id=e27610332666' target=_blank style='color:#2F92EE;'>#黑色素#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=24, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=103326, encryptionId=e27610332666, topicName=黑色素)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=150614999302, createdName=cqlidoudou, createdTime=Sat Apr 06 11:19:00 CST 2019, time=2019-04-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1561997, encodeId=2b63156199e86, content=<a href='/topic/show?id=309f509e9a' target=_blank style='color:#2F92EE;'>#CORE#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=5097, encryptionId=309f509e9a, topicName=CORE)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a12645, createdName=docwu2019, createdTime=Sat Apr 06 11:19:00 CST 2019, time=2019-04-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1564969, encodeId=3f0d156496900, content=<a href='/topic/show?id=e27610332666' target=_blank style='color:#2F92EE;'>#黑色素#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=22, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=103326, encryptionId=e27610332666, topicName=黑色素)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=150614999302, createdName=cqlidoudou, createdTime=Sat Apr 06 11:19:00 CST 2019, time=2019-04-06, status=1, ipAttribution=)]
    2019-05-24 sunylz
  5. 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  6. 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  7. 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GetPortalCommentsPageByObjectIdResponse(id=1558960, encodeId=4b04155896011, content=<a href='/topic/show?id=e27610332666' target=_blank style='color:#2F92EE;'>#黑色素#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=24, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=103326, encryptionId=e27610332666, topicName=黑色素)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=150614999302, createdName=cqlidoudou, createdTime=Sat Apr 06 11:19:00 CST 2019, time=2019-04-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1561997, encodeId=2b63156199e86, content=<a href='/topic/show?id=309f509e9a' target=_blank style='color:#2F92EE;'>#CORE#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=5097, encryptionId=309f509e9a, topicName=CORE)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a12645, createdName=docwu2019, createdTime=Sat Apr 06 11:19:00 CST 2019, time=2019-04-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1564969, encodeId=3f0d156496900, content=<a href='/topic/show?id=e27610332666' target=_blank style='color:#2F92EE;'>#黑色素#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=22, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=103326, encryptionId=e27610332666, topicName=黑色素)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=150614999302, createdName=cqlidoudou, createdTime=Sat Apr 06 11:19:00 CST 2019, time=2019-04-06, status=1, ipAttribution=)]
  8. 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GetPortalCommentsPageByObjectIdResponse(id=1558960, encodeId=4b04155896011, content=<a href='/topic/show?id=e27610332666' target=_blank style='color:#2F92EE;'>#黑色素#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=24, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=103326, encryptionId=e27610332666, topicName=黑色素)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=150614999302, createdName=cqlidoudou, createdTime=Sat Apr 06 11:19:00 CST 2019, time=2019-04-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1561997, encodeId=2b63156199e86, content=<a href='/topic/show?id=309f509e9a' target=_blank style='color:#2F92EE;'>#CORE#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=5097, encryptionId=309f509e9a, topicName=CORE)], attachment=null, authenticateStatus=null, createdAvatar=, 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  9. 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    2019-04-06 docwu2019
  10. 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