19.25亿，艾伯维引进CD3/BCMA/CD38管线

药渡2025-07-13

▎追溯2025 年 7 月 10 日，艾伯维 (NYSE: ABBV) 和纽约Ichnos Glenmark Innovation, Inc. (IGI)的全资子公司 IGI Therapeutics SA宣布了一项独家许可协议，针对 IGI 的主要研究资产 ISB 2001，该资产使用 IGI 专有的 BEAT 蛋白质平台开发，用于治疗肿瘤和自身免疫性疾病。ISB 2001 是同类首创的三...

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(IGI)的全资子公司 IGI Therapeutics SA宣布了一项独家许可协议，针对 IGI 的主要研究资产 ISB 2001，该资产使用 IGI 专有的 BEAT 蛋白质平台开发，用于治疗肿瘤和自身免疫性疾病。ISB 2001 是同类首创的三...</p>\n\n<a href=\"http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN20250713073357a447180c&s=b\">网页链接</a>\n\n</div>\n\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"LU1066051225.USD","symbol_name":"HSBC GIF GLOBAL EQUITY VOLATILITY FOCUSED \"AC\" (USD) ACC","start_time":0,"source_url":"http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN20250713073357a447180c&s=b","article_id":"2551912315","we_media_id":null,"thumbnails":[],"rights":{"source":"tencent","url":"http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN20250713073357a447180c&s=b","rn_cache_url":null,"customStyle":"body{padding-top:10px;}#news_title{font-weight:bold;#titleStyle#;}#news_description span{font-size:12px;#descriptionStyle#;}.footer-note{#statement#}","selectors":".mod-LoadTzbdNews, body","filters":".relate-stock, .hot-list, .recom-box, .wx-sou","directOrigin":true},"url":"https://stock-news.laohu8.com/highlight/detail?id=2551912315","pubTimestamp":1752363052,"columns":[],"sourceInfo":{"source_id":"tencent","name":"腾讯"},"weMediaInfo":null,"summary":"ISB 2001 是同类首创的三特异性 T 细胞接合剂，靶向骨髓瘤细胞上的 BCMA 和 CD38 以及 T 细胞上的 CD3，目前正处于复发/难治性多发性骨髓瘤的 I 期临床研究。在25 名对抗 CD38 疗法有耐药性的患者中，ORR 为 72%，CR/sCR 率为 24%。在15 名接受过 BCMA 靶向治疗的患者中，ORR 为 73%，CR/sCR 率为 27%。CD3/BCMA/CD38三抗业界做的人不多，其实2020年有文章初步显示，做三抗具有一定可行性。","collect":0,"end_time":0,"defaultTopTitle":"qq.com","property":[],"viewcount":null,"language":"zh","relate_stocks":{"LU1066051225.USD":"HSBC GIF GLOBAL EQUITY VOLATILITY FOCUSED \"AC\" (USD) ACC","LU1496350502.SGD":"FRANKLIN DIVERSIFIED DYNAMIC \"A\" (SGDHDG) ACC","LU2237443465.HKD":"abrdn SICAV I -  GLOBAL DYNAMIC DIVIDEND \"A\" (HKD) INC","IE00B2B36J28.USD":"JANUS HENDERSON GLOBAL LIFE SCIENCES \"I1\" (USD) INC","LU0965508806.USD":"AB LOW VOLATILITY EQUITY PORTFOLIO \"AD\" (USD) INC","LU1267930573.SGD":"TEMPLETON GLOBAL \"AA\" (SGD) ACC A","LU1934455277.USD":"AB SICAV I LOW VOLATILITY TOTAL RETURN EQUITY PORT \"AD\" (USD) INC","LU2505996681.GBP":"WELLINGTON MULTI-ASSET HIGH INCOME \"AM4H\" (GBPHDG) INC","BK4007":"制药","LU0114720955.EUR":"SUSTAINABLE GLOBAL HEALTH CARE \"A\" INC","IGI":"Western Asset Investment Grade D","LU1674673691.USD":"HSBC GIF GLOBAL LOWER CARBON EQUITY \"AD\" (USD) INC","LU0965509283.SGD":"AB LOW VOLATILITY EQUITY PORTFOLIO \"AD\" (SGDHDG) INC","LU0889566641.SGD":"FTSF - Templeton Shariah Global Equity A Acc SGD","LU0820561909.HKD":"ALLIANZ INCOME AND GROWTH \"AM\" (HKD) INC","LU1914381329.SGD":"Allianz Best Styles Global Equity Cl ET Acc H2-SGD","JNJ":"强生","LU2602419157.SGD":"HSBC ISLAMIC GLOBAL EQUITY INDEX \"AC\" (SGD) ACC","ABBV":"艾伯维公司","LU1244550221.USD":"FRANKLIN GLOBAL MULTI-ASSET  INCOME \"A\" (USDHEDGED) INC (M)","LU0320765646.SGD":"FTIF - Franklin Income A MDIS SGD-H1","IE00B3PB1722.GBP":"GUINNESS GLOBAL EQUITY INCOME \"C\" (GBP) INC","BK4566":"资本集团","LU1267930490.SGD":"TEMPLETON GLOBAL EQUITY INCOME \"AS\" (SGD) INC A","IE00BJJMRZ35.SGD":"JANUS HENDERSON GLOBAL LIFE SCIENCES \"I2\" (SGDHDG) ACC","LU0708994859.HKD":"TEMPLETON GLOBAL \"A\" (HKD) ACC","IE00BDGV0183.EUR":"GUINNESS GLOBAL EQUITY INCOME \"C\" (EUR) INC","LU2347655156.SGD":"JPMorgan Investment Funds - Global Income A (icdiv) SGD-H","LU0256863811.USD":"ALLIANZ US EQUITY \"A\" INC","BK4592":"伊斯兰概念","IE00B7SZL793.SGD":"Legg Mason Royce - US Small Cap Opportunity A Acc SGD-H","LU2087621335.USD":"ALLSPRING GLOBAL FACTOR ENHANCED EQUITY \"A\" (USD) ACC","LU1032466523.USD":"高盛全球多资产收益组合Acc","IE00B4R5TH58.HKD":"JANUS HENDERSON GLOBAL LIFE SCIENCES \"A2\" (HKD) ACC","LU0689472784.USD":"安联收益及增长基金Cl AM AT Acc","BK4568":"美国抗疫概念","RR":"Richtech Robotics","LU2089284900.SGD":"Allianz Global Sustainability Cl AM Dis H2-SGD","LU0861579265.USD":"联博低波幅策略股票基金A","CRS":"卡朋特科技","IE0004445239.USD":"JANUS HENDERSON US FORTY \"A2\" (USD) ACC","LU0456855351.SGD":"JPMorgan Funds - Global Equity A (acc) SGD","LU0211327993.USD":"TEMPLETON GLOBAL EQUITY INCOME \"A\" (USD) ACC","LU0792757196.USD":"TEMPLETON SHARIAH GLOBAL EQUITY FUND \"A\" (USD) ACC","SG9999015945.SGD":"LionGlobal Disruptive Innovation Fund A SGD","IE00B66KJ199.SGD":"LEGG MASON ROYCE US SMALL CAP OPPORTUNITY  \" A\" (SGD) ACC","LU1894683264.USD":"AMUNDI FUNDS US EQUITY RESEARCH VALUE \"A2\" (USD) ACC","IE00BVYPNW00.USD":"GUINNESS GLOBAL EQUITY INCOME \"C\" (USD) ACC","LU2430703251.USD":"WELLINGTON MULTI-ASSET HIGH INCOME \"AM4\" (USD) INC","LU1093756325.SGD":"FTIF - Franklin K2 Alt Strat Fd A (acc) SGD-H1"},"translate_title":"1.925 billion, AbbVie introduced CD3/BCMA/CD38 pipeline","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"ABBV":0.9,"IGI":1,"RR":1,"JNJ":0.9,"CRS":1},"content_text":"▎追溯2025 年 7 月 10 日， 艾伯维 (NYSE: ABBV) 和纽约Ichnos Glenmark Innovation, Inc. (IGI)的全资子公司 IGI Therapeutics SA宣布了一项独家许可协议，针对 IGI 的主要研究资产 ISB 2001，该资产使用 IGI 专有的 BEAT 蛋白质平台开发，用于治疗肿瘤和自身免疫性疾病。ISB 2001 是同类首创的三特异性 T 细胞接合剂，靶向骨髓瘤细胞上的 BCMA 和 CD38 以及 T 细胞上的 CD3，目前正处于复发/难治性多发性骨髓瘤的 I 期临床研究。根据协议条款，艾伯维将获得在北美、欧洲、日本和大中华区开发、生产和商业化 ISB 2001 的独家权利。经监管部门批准后，IGI 将获得7 亿美元的预付款，并有资格获得高达12.25 亿美元的开发、监管和商业里程碑付款，以及基于净销售额的分级两位数特许权使用费。Ichnos Glenmark的BCMA/CD38/CD3三抗ISB2001，该抗体采用1:1:1设计，并且在Fc段引入了L234A、L235A和P329A突变，去除ADCC效应，另外其通过共同轻链放在轻链和重链错配。该药物最近在 2025 年美国临床肿瘤学会 (ASCO) 年会上以快速口头报告的形式进行了展示（摘要编号 #7514），共计35例患者，在研究开始时至少接受过一个月的随访，中位数为六线治疗（范围：3-11）。ISB 2001 在有效剂量水平下表现出较高的缓解率，其中33例患者接受≥ 50 µg/kg 剂量治疗（剂量水平 3-9）。无论既往治疗线数或耐药状态如何，疗效均持久且随时间推移而加深，这进一步证实了 ASH 2024 年会上报告的先前研究结果，该研究纳入了18例接受≥ 50 µg/kg ISB 2001 治疗的患者：ORR 为 79%(26/33)，其中CR/sCR 率为 30%(10/33)，中位随访时间为 6.3 个月（范围：1-16）。在达到 CR/sCR 的 10 名患者中，8 名可评估微小残留病 (MRD)，6 名实现MRD 阴性，表明分子或流式细胞术检测未检测到灵敏度为 10-5 的骨髓瘤细胞，并增强了反应深度。在25 名对抗 CD38 疗法有耐药性的患者中，ORR 为 72%，CR/sCR 率为 24%。在19 名未接受过 T 细胞定向治疗(TCDT)（包括双特异性抗体和/或 CAR T 细胞疗法）的患者中，ORR 为 84%，CR/sCR 率为 32%。在之前接受过 TCDT 治疗的 14 名患者中，ORR 仍保持在 71% 的较高水平，CR/sCR 率为 28%。在15 名接受过 BCMA 靶向治疗的患者中，ORR 为 73%，CR/sCR 率为 27%。ISB 2001 的中位半衰期约为 17 天，这支持了降低给药频率的潜力。ISB 2001 在整个剂量递增阶段表现出良好的安全性，未报告剂量限制性毒性 (DLT)。24 例患者（69%）出现细胞因子释放综合征 (CRS)，主要为 1 级，仅有 4 例患者出现 2 级事件。CRS 主要发生在 ISB 2001 的首次给药，未观察到严重或危及生命的病例。药物相关的严重感染并不常见（4 例患者，11%），且未报告 4 级或更高级别的感染。1 例患者出现 1 级 ICANS；未报告其他药物相关的神经系统不良事件。CD3/BCMA/CD38三抗业界做的人不多，其实2020年有文章初步显示，做三抗具有一定可行性。而我也在2020年5月4日介绍过一篇文章“CD38达雷木单抗联用CD3/BCMA双抗临床前疗效显著！”摘录文章如下：如题。“Preclinical  activity of JNJ-7957, a novel BCMAxCD3 bispecific antibody for the  treatment of multiple myeloma, is potentiated by daratumumab“首先BCMA/CD3双特异抗体的体外数据确实不错。BCMA/CD3双特异抗体的杀伤效果，跟BCMA的表达也没有相关性。Killing  capacity was independent of BCMA expression levels and only moderately  affected by the immune suppressive BM microenvironment (BMSCs,Bone marrow stromal cells).To evaluate whether clinical resistance to bortezomib, lenalidomide,  and/or daratumumab has an impact on the activity of JNJ-7957, we  analyzed JNJ-7957-mediated killing of BM-localized MM cells from NDMM  and RRMM (newly diagnosed (ND) or relapsed/refractory (RR) MM)patients  in flow cytometry-based cytotoxicity assays.Interestingly，最后发现从经daratumumab治疗的患者提取的BM-MNCs，JNJ-7957具有更好的药效。作者Hypothesized  that the improved JNJ-7957 mediated MM cell killing after in vivo  daratumumab treatment is the result of these immunomodulatory effects.又做了这样一个实验，RPMI-8226  cells were treated with JNJ-7957 in the presence of PB-MNCs from these  patients. JNJ-7957-mediated MM cell lysis was superior in the presence  of the daratumumab-exposed PB-MNCs, when compared to the  daratumumab-naïve PB-MNCs.确实，daratumumab-exposed PB-MNCs药效会好一些。作者不放心，又进一步做了相关实验，To  assess if daratumumab treatment is also beneficial for other T-cell  redirecting therapies, we treated CD19+ Raji cells with blinatumomab, an  FDA-approved CD19xCD3 BiTE for the treatment of acute lymphoblastic  leukemia, using paired daratumumab-naïve and exposed PB-MNCs from11 of  these 13 MM patients.Similar  to our observations with JNJ-7957,the activity of blinatumomab was  significantly enhanced by co-incubation with daratumumab exposed  PB-MNCs, when compared to daratumumab-naïve PB-MNCs与CD3/BCMA双抗结果相似。Daratumumab确实能够提高CD3双抗的杀伤作用。为此作者作出了解释，说了CD38抗体的两个作用，一个是its classic Fc-dependent immune effector mechanisms，一个是CD38-targeting antibodies improve anti-tumor T-cell immune response by increasing NAD+ levels in T-cells.然后又强调，Importantly,  although daratumumab-refractory MM cells were resistant to the direct  effects of daratumumab, our results indicate that the immunomodulatory  effects ofdaratumumab are preserved in daratumumab-refractory patients  and contribute toimmune-mediated killing of MM cells.相当于没解释。一切靠数据说话。那么直接联用的效果怎么样呢？Direct combination of daratumumab and JNJ-7957 enhances MMcell lysis by JNJ-7957 in anadditive fashion.在经过daratumumab治疗过的患者BM-MNCs，daratumumab与JNJ-7957直接联用药效并未增强，但未经daratumumab治疗的BM-MNCs药效确实有明显增强。作者对CD3/BCMA双抗的数据很有信心。","kind":"news","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"1","news_tag":"corporation","news_rank":0,"isVideo":false,"video":null,"symbols":[],"gpt_button":1,"need_auth":false,"need_login_tip":false,"code":"91000000","status":"200"},"commentList":[],"isCommentEnd":true,"newsSizeData":{"likeSize":0,"commentSize":0,"repostSize":0,"favoriteSize":0,"likeStatus":false,"favoriteStatus":false},"APP":{"userAgent":"Mozilla/5.0 AppleWebKit/537.36 (KHTML, like Gecko; compatible; ClaudeBot/1.0; +claudebot@anthropic.com)","isDev":false,"isTTM":false,"tenantId":"TBCN","deviceId":"web-server-community-laohu8-v3","version":"4.42.0","shortVersion":"4.42.0","platform":"web","vendor":"web","appName":"laohu8","isIOS":false,"isAndroid":false,"isTiger":false,"isTHS":false,"isWeiXin":false,"isWeiXinMini":false,"isWeiBo":false,"isQQ":false,"isBaiduSwan":false,"isBaiduBox":false,"isDingTalk":false,"isToutiao":false,"isOnePlus":false,"isHuaWei":false,"isXiaomi":false,"isXiaomiWebView":false,"isOppo":false,"isVivo":false,"isSamsung":false,"isMobile":false},"href":"/m/news/2551912315","isCrawlerRequest":true}