Caribou Biosciences Announces FDA Clearance of its IND for CB-010, an Off-the-shelf Allogeneic Anti-CD19 CAR-T Cell Therapy

On September 8, 2020 Caribou Biosciences, Inc., a leading CRISPR genome editing company, reported that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for CB-010, an off-the-shelf allogeneic anti-CD19, genome-edited CAR-T cell therapy for patients with relapsed/refractory B cell non-Hodgkin lymphoma (B-NHL) (Press release, Caribou Biosciences, SEP 8, 2020, View Source [SID1234564769]).

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Upon initiation of the ANTLER Phase 1 trial, CB-010 will be Caribou’s first clinical-stage product candidate. CB-010 is manufactured from healthy donor T cells using Caribou’s next-generation CRISPR genome editing technology. Through genome editing, PD-1 is deleted from the CAR-T cells, which in preclinical studies promoted an increase in the durability of antitumor activity. Genome editing is used to remove the endogenous T cell receptor in order to prevent graft-versus-host disease and to site-specifically insert the CAR into the CAR-T genome.

"We are excited to receive clearance for our first IND, a pivotal milestone in the continued evolution of Caribou," said Rachel Haurwitz, Ph.D., Caribou’s President and Chief Executive Officer. "Caribou’s genome-edited cell therapies hold tremendous potential for patients and we are eager to begin clinical studies for CB-010."

ANTLER is an open-label study designed to evaluate the safety and efficacy of a single dose of CB-010 in adult patients with different subtypes of relapsed/refractory B-NHL. The study will be conducted at multiple clinical trial sites in the United States, and enrollment is expected to begin later this year.

"B-NHL comprises multiple serious and life-threatening diseases, and CB-010 therapy has the potential to extend lives," said Steve Kanner, Ph.D., Caribou’s Chief Scientific Officer. "CB-010 is distinct among allogeneic CAR-Ts since the critical checkpoint PD-1 is eliminated to reduce CAR-T cell exhaustion, which we believe offers a crucial therapeutic advantage."