FDA授予Ilixadencel治疗肝细胞癌(HCC)的“孤儿药称号”

2021-01-02 Allan MedSci原创

制药公司Immunicum近日宣布,美国食品药品监督管理局(FDA)已经授予Ilixadencel治疗肝细胞癌(HCC)的“孤儿药称号”(ODD)。

肝细胞癌(HCC)是成年人中最常见类型的慢性肝癌,并且在肝硬化的患者中也是最常见的死亡原因。它发生在慢性肝脏炎症的环境中,并且与慢性病毒性肝炎感染(乙型肝炎或丙型肝炎)、酒精或毒素(如黄曲毒素)等接触相关性极高。

制药公司Immunicum近日宣布,美国食品药品监督管理局(FDA)已经授予Ilixadencel治疗肝细胞癌(HCC)的“孤儿药称号”(ODD)。该公司的主要候选药物ilixadencel是一种基于细胞的免疫产品,用于治疗肝细胞癌(HCC)。该批准基于ilixadencel治疗无法切除和/或转移性HCC的I / II期临床试验的最新结果。

ilixadencel是一种同种异体树突状细胞(DC)疗法,被开发为一种通用型(off-the-shelf)癌症免疫触发剂(cancer immune primer),通过瘤内注射,用于多种实体瘤的治疗。

ilixadencel的活性成分是来源于健康献血者的树突状细胞(DC),这些细胞被特别激活,可产生大量强有力的免疫刺激因子。通过肿瘤内注射给药后,这些细胞会引起局部炎症反应,招募和活化患者自身的DC细胞和自然杀伤细胞(NK)进入肿瘤环境中,破坏肿瘤细胞,释放出全套的肿瘤特异性蛋白——新抗原(neoantigen)。这些新抗原将作为抗原来源,导致患者细胞毒T细胞的肿瘤特异性激活,特别是细胞毒性CD8+T细胞,从而产生一种高度个体化的、强效的抗肿瘤反应。
 

Immunicum的首席执行官医学博士Sven Rohmann表示:“基于ilixadencel在各种实体瘤适应症中的广泛潜力,我们将为进一步的临床开发继续努力”。

2020年5月,Immunicum从FDA获得了ilixadencel的再生医学高级疗法(RMAT)称号,用于治疗转移性肾细胞癌患者。2020年12月,Immunicum宣布获得美国FDA授予ilixadencel的快速通道指定,以作为胃肠道间质瘤(GIST)的治疗药物。

原始出处:

https://www.firstwordpharma.com/node/1787802?tsid=4

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    2021-04-04 维他命
  4. [GetPortalCommentsPageByObjectIdResponse(id=1241286, encodeId=6a6512412861f, content=<a href='/topic/show?id=36a59e3106' target=_blank style='color:#2F92EE;'>#ilixadencel#</a>治疗<a href='/topic/show?id=735a81364b7' target=_blank style='color:#2F92EE;'>#肝细胞癌#</a>(HCC)的<a href='/topic/show?id=dad04542ede' target=_blank style='color:#2F92EE;'>#孤儿药#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=77, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9731, encryptionId=36a59e3106, topicName=ilixadencel), TopicDto(id=81364, encryptionId=735a81364b7, topicName=肝细胞癌), TopicDto(id=45427, encryptionId=dad04542ede, topicName=孤儿药)], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20220519/c2ab253484ee4527a2d4e9589a4821ac/45de9bf494a54becb2ea4369c9d11e85.jpg, createdBy=7a3710, createdName=循证小兵, createdTime=Sat Aug 27 01:08:12 CST 2022, time=2022-08-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1979053, encodeId=9ca219e905332, content=<a href='/topic/show?id=3b90e79787f' target=_blank style='color:#2F92EE;'>#细胞癌#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=77978, encryptionId=3b90e79787f, topicName=细胞癌)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e457184, createdName=qingting, createdTime=Sun Dec 05 05:00:37 CST 2021, time=2021-12-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1962421, encodeId=d53c196242143, content=<a href='/topic/show?id=dbe6445416' target=_blank style='color:#2F92EE;'>#CEL#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4454, encryptionId=dbe6445416, topicName=CEL)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c3ff68, createdName=维他命, createdTime=Sun Apr 04 13:00:37 CST 2021, time=2021-04-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1259522, encodeId=59b71259522ae, content=<a href='/topic/show?id=2200854517' target=_blank style='color:#2F92EE;'>#HCC#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=8545, encryptionId=2200854517, topicName=HCC)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8e4c53, createdName=jiyangfei, createdTime=Mon Jan 04 04:00:37 CST 2021, time=2021-01-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1365257, encodeId=55b2136525e94, content=<a href='/topic/show?id=dfa045434e1' target=_blank style='color:#2F92EE;'>#孤儿药称号#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=45434, encryptionId=dfa045434e1, topicName=孤儿药称号)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=cd0d217, createdName=huiwelcome, createdTime=Mon Jan 04 04:00:37 CST 2021, time=2021-01-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=913316, encodeId=ff2d913316f5, content=认真学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=69, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo6EF3hKja8nER8RMzxQdria9eCYFhgLTLsDOeqnvIYdeLDz5eP6EnicLuE5gibiawgno4zUA0jAR7Nbtp2llQ9fs3Mk/0, createdBy=278f1986883, createdName=医鸣惊人, createdTime=Sun Jan 03 15:39:09 CST 2021, time=2021-01-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=913107, encodeId=3e8091310e5b, content=好文章!, beContent=null, objectType=article, channel=null, level=null, likeNumber=85, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cacheapi.medsci.cn/resource/upload/20160806/IMG57A5698BDB0244113.jpg, createdBy=32a91358059, createdName=jyzxjiangqin, createdTime=Sat Jan 02 17:07:38 CST 2021, time=2021-01-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1863528, encodeId=b9231863528ba, content=<a href='/topic/show?id=c0b68135561' target=_blank style='color:#2F92EE;'>#肝细胞#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=81355, encryptionId=c0b68135561, topicName=肝细胞)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=d59291, createdName=xjy02, createdTime=Sat May 15 13:00:37 CST 2021, time=2021-05-15, status=1, ipAttribution=)]
    2021-01-04 jiyangfei
  5. [GetPortalCommentsPageByObjectIdResponse(id=1241286, encodeId=6a6512412861f, content=<a href='/topic/show?id=36a59e3106' target=_blank style='color:#2F92EE;'>#ilixadencel#</a>治疗<a href='/topic/show?id=735a81364b7' target=_blank style='color:#2F92EE;'>#肝细胞癌#</a>(HCC)的<a href='/topic/show?id=dad04542ede' target=_blank style='color:#2F92EE;'>#孤儿药#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=77, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9731, encryptionId=36a59e3106, topicName=ilixadencel), TopicDto(id=81364, encryptionId=735a81364b7, topicName=肝细胞癌), TopicDto(id=45427, encryptionId=dad04542ede, topicName=孤儿药)], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20220519/c2ab253484ee4527a2d4e9589a4821ac/45de9bf494a54becb2ea4369c9d11e85.jpg, createdBy=7a3710, createdName=循证小兵, createdTime=Sat Aug 27 01:08:12 CST 2022, time=2022-08-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1979053, encodeId=9ca219e905332, content=<a href='/topic/show?id=3b90e79787f' target=_blank style='color:#2F92EE;'>#细胞癌#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=77978, encryptionId=3b90e79787f, topicName=细胞癌)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e457184, createdName=qingting, createdTime=Sun Dec 05 05:00:37 CST 2021, time=2021-12-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1962421, encodeId=d53c196242143, content=<a href='/topic/show?id=dbe6445416' target=_blank style='color:#2F92EE;'>#CEL#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4454, encryptionId=dbe6445416, topicName=CEL)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c3ff68, createdName=维他命, createdTime=Sun Apr 04 13:00:37 CST 2021, time=2021-04-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1259522, encodeId=59b71259522ae, content=<a href='/topic/show?id=2200854517' target=_blank style='color:#2F92EE;'>#HCC#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=8545, encryptionId=2200854517, topicName=HCC)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8e4c53, createdName=jiyangfei, createdTime=Mon Jan 04 04:00:37 CST 2021, time=2021-01-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1365257, encodeId=55b2136525e94, content=<a href='/topic/show?id=dfa045434e1' target=_blank style='color:#2F92EE;'>#孤儿药称号#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=45434, encryptionId=dfa045434e1, topicName=孤儿药称号)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=cd0d217, createdName=huiwelcome, createdTime=Mon Jan 04 04:00:37 CST 2021, time=2021-01-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=913316, encodeId=ff2d913316f5, content=认真学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=69, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo6EF3hKja8nER8RMzxQdria9eCYFhgLTLsDOeqnvIYdeLDz5eP6EnicLuE5gibiawgno4zUA0jAR7Nbtp2llQ9fs3Mk/0, createdBy=278f1986883, createdName=医鸣惊人, createdTime=Sun Jan 03 15:39:09 CST 2021, time=2021-01-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=913107, encodeId=3e8091310e5b, content=好文章!, beContent=null, objectType=article, channel=null, level=null, likeNumber=85, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cacheapi.medsci.cn/resource/upload/20160806/IMG57A5698BDB0244113.jpg, createdBy=32a91358059, createdName=jyzxjiangqin, createdTime=Sat Jan 02 17:07:38 CST 2021, time=2021-01-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1863528, encodeId=b9231863528ba, content=<a href='/topic/show?id=c0b68135561' target=_blank style='color:#2F92EE;'>#肝细胞#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=81355, encryptionId=c0b68135561, topicName=肝细胞)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=d59291, createdName=xjy02, createdTime=Sat May 15 13:00:37 CST 2021, time=2021-05-15, status=1, ipAttribution=)]
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    2021-01-03 医鸣惊人

    认真学习了

    0

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    2021-01-02 jyzxjiangqin

    好文章!

    0

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    2021-05-15 xjy02

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