Caribou Bio Wins 2 Designations from FDA

FDA has granted Caribou Biosciences a Regenerative Medicine Advanced Therapy designation for CB-010 and its use in treating relapsed or refractory large B cell lymphoma (LBCL), and a Fast Track designation for relapsed or refractory B cell non-Hodgkin lymphoma (r/r B-NHL).

CB-010 is described by the company as an “allogeneic anti-CD19 CAR-T cell therapy with a PD-1 knockout.” It is being evaluated in the ongoing ANTLER Phase 1 clinical trial in patients with r/r B-NHL, which can enroll three LBCL subtypes: diffuse large B cell lymphoma, primary mediastinal large B cell lymphoma, and high-grade B cell lymphoma, it says.

“CB-010 is the first allogeneic anti-CD19 CAR-T cell therapy in the clinic with a PD-1 knockout, a genome-editing strategy designed to improve the persistence of antitumor activity by limiting premature CAR-T cell exhaustion,” Caribou says.