California-based CRISPR gene-editing company Caribou Biosciences has received Fast Track designations from the US FDA for two of its investigational therapies: CB-010, which is aimed at refractory systemic lupus erythematosus (SLE) and relapsed or refractory B-cell non-Hodgkin lymphoma (r/r B-NHL), and CB-012, which is aimed at relapsed or refractory acute myeloid leukemia (r/r AML).
CB-010, an allogeneic anti-CD19 CAR T-cell therapy, includes a genome-editing strategy designed to improve activity against diseases by limiting premature CAR T-cell exhaustion. It is being tested for two subcategories of SLE: Lupus nephritis (LN) and extrarenal lupus (ERL) in the ANTLER Phase I trial and for r/r B-NHL in the GALLOP Phase I trial. CB-012, an allogeneic anti-CLL-1 CAR T-cell therapy, is engineered with five CRISPR-based genome edits using Cas12a chRDNA genome editing. It is being evaluated in the AMpLify Phase I trial for relapsed or refractory acute myeloid leukemia.
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