regulatory
confidence high
sentiment positive
materiality 0.65
Sana Biotechnology receives FDA IND clearance for SC291 allogeneic CAR T therapy in B-cell malignancies
Sana Biotechnology, Inc.
- FDA cleared IND for SC291, a CD19-targeted allogeneic CAR T therapy using Sana's hypoimmune platform, in patients with B-cell lymphomas or leukemias.
- Goal to report initial SC291 clinical data in 2023; second IND for SC262 (CD22-targeted) expected this year.
- Hypoimmune platform disrupts MHC class I/II expression and overexpresses CD47 to evade immune rejection.
- Preclinical data shown across models; platform also being developed for pancreatic islet cell therapy in type 1 diabetes.