FDA Grants Fast Track Designations to Caribou Biosciences' CB-010 and CB-012 for Refractory SLE and AML
Caribou Biosciences, Inc., a leading clinical-stage CRISPR genome-editing biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designations to CB-010 for refractory systemic lupus erythematosus (SLE) and to CB-012 for relapsed or refractory acute myeloid leukemia (r/r AML).
CB-010, an allogeneic anti-CD19 CAR-T cell therapy, is set to be evaluated in the GALLOP Phase 1 clinical trial for patients with lupus nephritis (LN) and extrarenal lupus (ERL), with the trial expected to initiate by the end of 2024. CB-012, an allogeneic anti-CLL-1 CAR-T cell therapy, is currently being evaluated in the AMpLify Phase 1 clinical trial for patients with r/r AML.
The Fast Track designation is designed to facilitate the development and expedite the review of drugs that treat serious conditions and fill an unmet medical need. This designation allows for early and frequent communication with the FDA throughout the regulatory review process and may also qualify for Accelerated Approval and Priority Review.
Dr. Tina Albertson, Caribou’s chief medical officer, expressed enthusiasm about the designations, highlighting the potential of CB-010 and CB-012 as readily available, off-the-shelf CAR-T cell therapies. She noted the encouraging safety and efficacy data from ongoing trials and the significant unmet need in treating these diseases.
CB-010 is also notable for being the first allogeneic CAR-T cell therapy in the clinic with a PD-1 knockout, aimed at improving activity against diseases by limiting premature CAR-T cell exhaustion. CB-012, on the other hand, is the first allogeneic CAR-T cell therapy with both checkpoint disruption and immune cloaking, designed to enhance antitumor activity.
Caribou Biosciences continues to advance its pipeline of off-the-shelf cell therapies from its CAR-T platform, aiming to provide transformative therapies for patients with devastating diseases.