regulatory
confidence high
sentiment positive
materiality 0.80
Caribou Biosciences receives FDA IND clearance for CB-010 in lupus; GALLOP Ph1 trial expected by YE 2024
Caribou Biosciences, Inc.
- FDA cleared IND for CB-010 (allogeneic anti-CD19 CAR-T) to treat lupus nephritis and extrarenal lupus.
- Phase 1 GALLOP trial expected to initiate by year-end 2024; evaluates safety of single infusion with partial HLA matching.
- CB-010 clinical development expanded from oncology to autoimmune diseases; driven by encouraging initial ANTLER trial data in r/r B-NHL.
- Caribou reports $372.4M cash as of Dec 31, 2023, expected to fund operations into Q1 2026.
- Initial dose expansion data from ANTLER Phase 1 trial for 2L LBCL to be presented at a medical congress in Q2 2024.