原始来源记录
决策级顶线结果
Sana Biotechnology：UP421 12周NEJM数据显示HIP胰岛细胞在T1D中存活并发挥功能
8-K报告了NEJM发表的UP421研究者发起研究12周积极结果，证实经低免疫修饰的同种异体胰岛细胞在1型糖尿病患者中存活、逃避免疫检测并在无需免疫抑制的情况下产生胰岛素。这些数据与近期FDA INTERACT反馈共同提升了相关SC451 iPSC衍生项目的监管信心，并支持最早于2026年提交IND申请。
关键事实
来源摘录
EX-99.1 2 sana-ex99_1.htm EX-99.1 EX-99.1 Exhibit 99.1 Sana Biotechnology Reports Third Quarter 2025 Financial Results and Business Updates Announced increased focus on type 1 diabetes and in vivo CAR T programs Regulatory interactions increase confidence in moving forward with GMP master cell bank for SC451, nonclinical testing plan, and path to filing SC451 Investigational New Drug Application (IND) as early as 2026 The New England Journal of Medicine published positive 12-week clinical results of ongoing type 1 diabetes study with UP421, which demonstrate that Sana’s hypoimmune-modified pancreatic islet cells are safe and well-tolerated, survive, evade detection by the immune system, and produce insulin in the patient Next-generation in vivo CAR T product candidate, SG293, demonstr