TAK-500

2025年5月8日，武田制药（Takeda）在公布其2024财年第四季度财报时，宣布对其研发管线进行重大调整。在肿瘤领域，武田制药宣布终止了其在2021年以5.25亿美元收购Maverick Therapeutics时获得的两个T细胞接合剂（TCE）项目：TAK-186（针对EGFR）：此项目在1/2期临床试验中已接近关键节点，武田决定停止进一步发展。TAK-280（针对B7-H3）：此项目在临床中也表现出一定潜力，但在继续推进之前，武田选择终止。此外，STING激动剂dazostinag也被撤出肿瘤研发管线，这一药物曾与默沙东的Keytruda联合进行2期临床试验。此次调整直接导致武田制药的1期和2期肿瘤管线规模减半，显示出公司在聚焦创新疗法上的决心。除了肿瘤领域的调整，武田制药还对其他研发项目进行了优化：danavorexton（TAK-925）：一种orexin-2受体激动剂，其2期临床试验因入组缓慢而被终止。TAK-007：一种CD19靶向CAR-NK疗法，原本用于B细胞恶性肿瘤治疗，已于去年停用。TAK-500：STING激动剂项目被撤出管线。武田制药表示，这些研发管线的调整是基于数据驱动的决策，旨在将公司资源集中于更具潜力的领域和项目。尽管精简了部分项目，武田制药目前仍保留6项处于3期临床阶段的高价值项目，涵盖罕见血液疾病、银屑病及神经疾病等多个领域。其中，治疗红细胞增多症的rusfertide在3月公布的3期试验结果中取得积极疗效，有望成为未来的重磅产品，峰值销售预估可达10亿至20亿美元。End声明：本公众号所有发文章(包括原创及转载文章)系出于传递更多信息之目的，且注明来源和作者。本公众号欢迎分享朋友圈或大群，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载/商务/投稿 | 联系微信15618157102（sum_Gmi）商务合作稿件征集点击了解详情往期回顾1集采政策重要拐点22025 AACR 中国ADC创新药物“起飞” | 附资料32025 ASCO热点速递 | 信达、荣昌、科伦集体登场!（附ADC/双/多抗最新进展一览表）

Several months into a multiyear quest to “rigorously prioritize” its pipeline, Takeda is cutting a handful of programs. The company revealed the changes on Thursday in its third-quarter earnings report , in which CEO Christophe Weber announced plans to retire in June 2026. Weber last year laid out the road map for a broad restructuring aimed at simplifying the company’s structure, removing layers and broadening roles. Takeda has also made several pipeline cuts over the last year, and it’s now ending work on a Phase 3 program for soticlestat in a form of epilepsy. In 2024, soticlestat failed separate Phase 3 trials in Dravet syndrome and Lennox-Gastaut syndrome, and Takeda had already discontinued development in the latter condition. After meeting with the FDA about an indication for Dravet syndrome, a genetic form of epilepsy, regulators said current data “would not be capable of demonstrating substantial evidence of effectiveness,” Takeda said. The company added that soticlestat’s financial impact on full-year results is “expected to be immaterial.” Another Phase 3 program is also getting the boot. Takeda said it’s stopping work on the Exelixis-partnered drug Cabometyx in combination with Roche’s Tecentriq in metastatic castration-resistant prostate cancer. Cabometyx was originally developed by Exelixis, and then Takeda inked a deal for commercial and development rights in Japan in 2017. The drug is currently approved in the US for thyroid cancer, hepatocellular carcinoma and renal cell carcinoma. Takeda said the decision to pull the Cabometyx-Tecentriq combo in metastatic castration-resistant prostate cancer was “based on the trial results and assessment of Takeda’s development strategy.” A Phase 1 trial for TAK-500 in solid tumors was also closed “due to dose-limiting toxicities.” For the second consecutive quarter, Takeda raised its full-year revenue guidance. The company said in October that it expects full-year revenue to come in flat or slightly increase. It now expects an increase in revenue by a low single-digit percentage. The company also touted three Phase 3 readouts coming in 2025, including oveporexton in narcolepsy type 1, zasocitinib in psoriasis, and rusfertide for a rare blood disorder called polycythemia vera. “We are focused on advancing our promising late-stage pipeline and preparing for future launches. I couldn’t be more excited about what lies ahead for Takeda,” Weber said during an analyst call.