Autolus的快速解离型CAR-T细胞疗法治疗急性淋巴细胞白血病,获FDA孤儿药物指定

2019-11-06 不详 MedSci原创

Autolus Therapeutics宣布,美国食品和药物管理局(FDA)已授予其下一代程序化T细胞疗法AUTO1的孤儿药指定,用于治疗急性淋巴细胞白血病(ALL)患者。

Autolus Therapeutics宣布,美国食品和药物管理局(FDA)已授予其下一代程序化T细胞疗法AUTO1的孤儿药指定,用于治疗急性淋巴细胞白血病(ALL)患者。

根据美国国立卫生研究院国家癌症研究所的数据,2019年将有5930例ALL新增病例和1500例相关死亡,大约60%的病例年龄小于20岁。当骨髓产生过多的不成熟淋巴细胞(一种白细胞)时,就会发生ALL。尽管对化疗的反应率很高,但只有30-40%的ALL成人患者可以实现长期缓解。类似地,儿科患者通常对一线治疗(联合化疗)反应良好,但总的患者中有10%至20%的患者具有化疗耐药性现象,导致高危复发或难治性ALL患者的未满足需求显着。

Autolus董事长兼首席执行官Christian Itin博士说:"我们很高兴收到用于急性淋巴细胞白血病的AUTO1孤儿药指定。目前的数据证实了AUTO1强大的缓解率,出色的CAR-T细胞扩增和持久性,却未诱导出严重的细胞因子风暴。"

AUTO1是一种CD19 CAR-T细胞研究性疗法,旨在克服与目前CD19 CAR-T细胞疗法相比安全性方面的局限性,同时保持相似的疗效水平。设计为具有快速的靶结合解离速率,以最大程度地减少程序化T细胞的过度活化,因此AUTO1可以降低毒性并且不易发生T细胞衰竭,这可以增强持久性并提高杀伤T细胞的能力。

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encodeId=275413022e692, content=<a href='/topic/show?id=82a6659902c' target=_blank style='color:#2F92EE;'>#淋巴细胞#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=23, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=65990, encryptionId=82a6659902c, topicName=淋巴细胞)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=1e34303, createdName=wetgdt, createdTime=Fri Nov 08 05:24:00 CST 2019, time=2019-11-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1478027, encodeId=daa314e802725, content=<a href='/topic/show?id=bb6f18030a4' target=_blank style='color:#2F92EE;'>#T细胞疗法#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=18030, encryptionId=bb6f18030a4, topicName=T细胞疗法)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=6bea7392214, createdName=124984edm24暂无昵称, createdTime=Fri Nov 08 05:24:00 CST 2019, time=2019-11-08, status=1, ipAttribution=)]
    2020-10-05 仁者大医
  5. 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encodeId=275413022e692, content=<a href='/topic/show?id=82a6659902c' target=_blank style='color:#2F92EE;'>#淋巴细胞#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=23, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=65990, encryptionId=82a6659902c, topicName=淋巴细胞)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=1e34303, createdName=wetgdt, createdTime=Fri Nov 08 05:24:00 CST 2019, time=2019-11-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1478027, encodeId=daa314e802725, content=<a href='/topic/show?id=bb6f18030a4' target=_blank style='color:#2F92EE;'>#T细胞疗法#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=18030, encryptionId=bb6f18030a4, topicName=T细胞疗法)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=6bea7392214, createdName=124984edm24暂无昵称, createdTime=Fri Nov 08 05:24:00 CST 2019, time=2019-11-08, status=1, ipAttribution=)]
    2020-03-06 weiz
  6. 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05:24:00 CST 2019, time=2019-11-08, status=1, ipAttribution=)]
  7. 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  8. 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