Caribou Biosciences, Inc. announced that the FDA 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, will be evaluated in the GALLOP Phase 1 clinical trial in patients with lupus nephritis (LN) and extrarenal lupus (ERL), subcategories of SLE. The GALLOP clinical trial is on track to initiate by year-end 2024. CB-012, an allogeneic anti-CLL-1 CAR-T cell therapy, is being evaluated in the company’s ongoing AMpLify Phase 1 clinical trial in patients with r/r AML.
“We are pleased to receive Fast Track designations from the FDA. This is a testament to the significant unmet need and the potential of CB-010 and CB-012 as readily available, off-the-shelf CAR-T cell therapies,” said Tina Albertson, MD, PhD, Caribou’s chief medical officer. “Based on previously reported data in our ongoing trial for patients with relapsed or refractory B cell non-Hodgkin lymphoma, CB-010 has shown encouraging safety, efficacy, and prolonged B cell aplasia following a single dose. Based on these data, we are eager to expand the clinical development program for CB-010 into LN and ERL, prevalent and severe autoimmune diseases.”
Dr. Albertson continued, “Most patients with acute AML are refractory or relapse quickly after currently available therapeutic options, and allogeneic hematopoietic stem cell transplant is the only potentially curative option after salvage chemotherapy regimens. As we advance CB-012 and enroll patients at dose level 2, we are focused on our goal to deliver an effective, off-the-shelf treatment option for patients living with this disease.”
Fast Track designation is intended to help rapidly advance the development and review processes for promising therapeutic candidates for serious conditions that may fill an unmet medical need. Clinical programs with Fast Track designation may benefit from early and frequent communication with the FDA throughout the regulatory review process and may also be eligible for Accelerated Approval and Priority Review when relevant criteria are met.
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