一次情報の記録
決定級トップライン結果
Sana Biotechnology:UP421の12週NEJMデータ、T1DにおいてHIP膵島細胞が生着・機能することを示す
The 8-K reports positive 12-week results from the UP421 investigator-sponsored study published in NEJM, confirming that hypoimmune-modified allogeneic islet cells survive, evade immune detection, and produce insulin without immunosuppression in a type 1 diabetes patient. These data, together with recent FDA INTERACT feedback, increase regulatory confidence for the related SC451 iPSC-derived program and support an IND filing as early as 2026.
主要事実
出典の抜粋
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