regulatory
confidence high
sentiment positive
materiality 0.45
Caribou Biosciences gets FDA Fast Track for CB-011 CAR-T in relapsed/refractory multiple myeloma
Caribou Biosciences, Inc.
- CB-011 is an allogeneic anti-BCMA CAR-T with immune cloaking (B2M-HLA-E transgene).
- Fast Track designation enables expedited FDA review and more frequent agency interactions.
- CaMMouflage Phase 1 trial enrolling at dose level 1; first patient dosed recently.
- CB-011 aims to be an off-the-shelf option avoiding apheresis and long manufacturing times.