Caribou Biosciences Gets FDA Granted Fast Track Designation for Allogeneic CAR-T Cell Therapy

Caribou Biosciences, a US-based clinical-stage biopharmaceutical company, has received fast track designation from FDA for CB-011, an allogeneic chimeric antigen receptor T cell (CAR-T) cell therapy in development for treating relapsed or refractory multiple myeloma. The candidate is currently in Phase I development.

To Caribou’s knowledge, CB-011 is the first allogeneic CAR-T cell therapy in the clinic, the company announced in an April 4, 2023 press release. It is engineered to improve antitumor activity through an immune-cloaking strategy. Its mode of action is achieved with a beta-2-microglobulin (B2M) knockout and insertion of a B2M–HLA-E fusion protein, which blunts immune-mediated rejection.

“Fast [t]rack designation for CB-011 allows us instrumental interactions with [FDA] as we progress our clinical development and regulatory plans for CB-011. This designation could not be more timely as we recently dosed our first patient in the [Phase I] 1 trial,” said Syed Rizvi, Caribou’s chief medical officer, in the press release. “Our goal is to develop CB-011 as a readily available off-the-shelf treatment option for patients with relapsed or refractory multiple myeloma to overcome the need for apheresis or bridging therapy, variable quality and long manufacturing timelines, manufacturing failures, or the inability to bear the burden of treatments that require frequent dosing over several months.”