regulatory
confidence high
sentiment positive
materiality 0.80
Senti Bio receives FDA IND clearance for SENTI-202 CAR-NK therapy for AML
Senti Biosciences, Inc.
- FDA cleared IND for SENTI-202, an off-the-shelf CAR-NK cell therapy targeting CD33/FLT3 hematologic malignancies including AML.
- Phase 1 trial expected to treat first patient in Q2 2024 at multiple US and Australia sites.
- Initial efficacy data expected by year-end 2024; durability data expected in 2025.
- Trial evaluates two dose levels (1 or 1.5 billion cells) with three weekly doses after lymphodepletion and optional continuation cycles.
- Manufacturing expenses for Phase 1 largely prepaid through existing GeneFab agreement.