Vicasinabin

转自：蒲公英Ouryao 整理：蒿山君近日，武田制药公布了上半年数据，砍掉了4条管线，业绩预期下调了高达71%。财报显示增长遇到一定的瓶颈。  武田砍掉了4条管线2023年武田上半年总销售约138.71亿美元，同比增长1.4%，但利润却大幅下滑，下降了53%，约为17.87亿美元。  武田产品管线可以分为五大部分，分别是：消化道产品、罕见病、血浆制品、精神疾病和抗肿瘤线。  其中，消化道产品是他们的核心管线，上半年实现同比增长9.2%，  报告显示，由于一系列不可控因素，导致了公司的净亏损增长，并且宣布砍掉4款研发产品管线，分别是：  1.Exkivity：治疗晚期非小细胞肺癌的产品，因III期临床试验无疗效获益而终止。  2.TAK-920/DNL-919：治疗AD类产品，因出现"中度、可逆的血液学效应"，停止了阿尔茨海默氏症（AD）药物的开发。  3.TAK-611：显示在在治疗异染性脑白质营养不良（MLD）的II期试验中未达到主要终点和次要终点而放弃研发。  4.TAK-105：由于数据表现不佳，治疗恶心和呕吐的候选药物TAK-105将停止研发。  一款新药的问世绝非易事，面对新药研发困难、销售业绩下滑等压力冲击，药企巨头也不得不做出管线调整的决定，看看各大外企每年在研发领域的投入以及每年宣布放弃的产品线就可想而知。多家药企砍管线  辉瑞砍5条管线：10月31日，第三季度财报的同一天，辉瑞宣布将削减5项临床项目，包括两个II期项目和三个I期项目，涉及癌症和皮肤病等领域。GSK砍3条管线：11月1日，公司财报显示，对其一期肿瘤项目进行了两项削减，中止了一个LAG-3靶向抗体和一个小分子STING激动剂-后者被称为GSK3745417。葛兰素史克还放弃了一个重组蛋白项目，该项目正处于治疗艰难梭菌的一期开发阶段。今年，GSK还结束对细胞基因疗法领域的投入。罗氏又砍掉4条管线：罗氏在近期公布的第三季度最新财报中透露，基于“全部疗效和安全性数据以及治疗领域不断变化的治疗格局”，放弃cibisatamab的实体瘤I期试验，Cibisatamab是一种与癌胚抗原结合的T细胞双特异性抗体。  因在TWAINI试验中的无效性分析失败，在TWAINII试验中也没有达到主要终点，放弃治疗精神分裂症的TAAR1激动剂ralmitaront的II期项目。  因在对中重度至重度非增殖性糖尿病视网膜病变患者进行的CANBERRAII期研究中，未能达到主要终点，放弃了治疗糖尿病视网膜病变的vicasinabin的II期项目。  因上个月的III期试验结果不及预期，罗氏还放弃了其BCL-2抑制剂Venclexta联合地塞米松治疗复发或难治性多发性骨髓瘤的研究，但Venclexta联合阿扎胞苷治疗一线骨髓增生异常综合征的III期试验仍在进行中。  值得注意的是，罗氏在一季度砍掉6条管线，半年报中提到，将终止几款候选药物开发，包括处于III期阶段的替奈普酶治疗卒中适应症，II期阶段血友病A基因疗法RG6358，以及4款尚处于I期研究阶段的新分子实体药物。艾伯维，删除2条管线：8月23日，艾伯维更新了管线，从其产品线中删除了2条ADC管线，包括ABBV-011和与辉瑞合作的ABBV-647。  百时美施贵宝，削减6个项目：9月14日，百时美施贵宝在其研发日公布削减研发管线，包括两个2期临床项目（HSP47和一个TIGIT实体瘤项目）和四个1期临床项目。  Moderna，删减4个管线：靠新冠疫苗暴富的Moderna，其将“在需要时”进行管道优先排序而剔除。其中包括两个阿斯利康合作后放弃的管线AZD8601、MEDI1191以及mRNA-1653、mRNA-1703。另外，今年以来，赛诺菲结束了BTK抑制剂atuzabrutinib的开发，停止度普利尤单抗的过敏性真菌性鼻炎和无鼻息肉的慢性鼻窦炎两个项目；诺华则砍去了在研管线中10%的非核心项目等。  参考：公司财报 华夏日报

Roche removed schizophrenia candidate ralmitaront from its midphase pipeline. Roche’s vision of developing an oral diabetic retinopathy treatment has taken a hit, with the drugmaker stopping development of vicasinabin after completing phase 2. The CB2 agonist was discarded (PDF) as part of a cull that also saw Roche pull back from its CEAxCD3 bispecific candidate cibisatamab. Vicasinabin, also known as RG7774, entered phase 2 in 2020. Roche pitched the candidate as a potential oral alternative to existing invasive treatments, such as injections into the eye, for a condition that leads to vision loss and blindness in some people with diabetes. However, the clinical trial, which finished in July, failed to persuade Roche to keep investing in the candidate. The action eliminates one of the leading oral contenders in diabetic retinopathy. Ocuphire Pharma has an oral candidate, APX3330, that has cleared phase 2. Bayer, InflammX and Rezolute also have oral, clinical-phase assets. Other companies, notably Boehringer Ingelheim, have swung at the indication and missed.  Roche dropped vicasinabin from its pipeline as part of a third quarter cull that also affected cibisatamab, a bispecific designed to bind to CD3 on T cells and CEA on cancer cells. Multiple companies have zeroed in on CEA as an attractive solid tumor drug target. Roche started a phase 1 trial of an older CEAxCD3 bispecific, RO6958688, in 2014 and followed up by taking cibisatamab into the clinic in 2019. The trial evaluated cibisatamab, also known as RG7802, in combination with Roche’s checkpoint inhibitor Tecentriq in colorectal cancer patients. Now, Roche has removed RG7802 in solid tumors from its phase 1 pipeline. The drugmaker continues to assess RG7802 in combination with RO7122290, a bispecific antibody-like fusion protein that simultaneously targets 4-1BB and FAP, in colorectal cancer.     Asked by Fierce Biotech about the pipeline changes on a conference call with the media this morning, Teresa Graham, CEO of Roche Pharmaceuticals, said: “I think these are both very early-stage assets that currently sit in our research and early development organizations.” “We've seen encouraging early data that would lead us to believe that further study is necessary or warranted,” Graham added. “So I would say stay tuned, and hopefully at an upcoming medical conference we'll have more data that we can share.” Roche also removed the schizophrenia candidate ralmitaront from its midphase pipeline. The company terminated a phase 2 trial of the asset earlier this year after an interim analysis found it was unlikely to meet the primary endpoint. Roche terminated another trial of the molecule last year.