原始出處紀錄
決策級主要結果 (Topline)
Sana Biotechnology：UP421 12週 NEJM 資料顯示 HIP 胰島細胞在 T1D 中存活並發揮功能
該 8-K 報告了 NEJM 發表的 UP421 研究者發起研究 12 週正面結果，證實經 hypoimmune 修飾的異體胰島細胞在 1 型糖尿病患者中存活、逃避免疫偵測，並在無免疫抑制的情況下產生胰島素。這些資料加上近期 FDA INTERACT 回饋，提升了相關 SC451 iPSC 衍生計畫的法規信心，並支持最早於 2026 年提交 IND 申請。
關鍵事實
來源摘錄
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