Berkeley, California-based Caribou Biosciences, Inc. (Nasdaq: CRBU) is discontinuing development of its two allogeneic chimeric antigen receptor T-cell (CAR-T) programs and has launched a formal strategic review that could result in a sale, merger, or transaction involving the company or its assets. The move will be accompanied by a substantial workforce reduction.
The discontinued programs are vispacabtagene regedleucel (vispa-cel), an allogeneic anti-CD19 CAR-T cell therapy for relapsed or refractory B cell non-Hodgkin lymphoma, and CB-011, an allogeneic anti-BCMA CAR-T cell therapy for relapsed or refractory multiple myeloma. Caribou said vispa-cel was pivotal-trial ready, with US FDA alignment reached on the design of a Phase III study. Both programs had received Regenerative Medicine Advanced Therapy, Fast Track, and Orphan Drug designations from the US FDA.
Chief executive Rachel Haurwitz said the decision reflected the financing environment rather than the company’s view of the programs’ clinical potential, citing increasing difficulty securing the capital needed to advance allogeneic CAR-T therapies.
The decision comes about four months after Caribou presented updated data for both programs at the European Hematology Association annual meeting. Vispa-cel produced an 82% overall response rate and 67% complete response rate in second-line large B cell lymphoma, with median progression-free survival of 17.1 months. CB-011 produced an 83% complete response rate and 91% minimal residual disease-negativity rate in heavily pretreated, BCMA-naïve multiple myeloma patients, with 50% remaining in at least complete response at 15 months. Caribou did not attribute the discontinuations to the clinical data.
Caribou’s board approved the restructuring and strategic-review process on October 2. Potential outcomes include a merger, acquisition, business combination, or other transaction involving Caribou or its assets, with Wedbush Securities serving as exclusive financial adviser. The company has not set a timeline for completing the review.