Caribou Biosciences provides regulatory update on CB-010 development program

Caribou Biosciences provided an update based on feedback from the FDA following recent communications and a Type B clinical meeting regarding the CB-010 development program. The company has received the FDA’s feedback on a Phase 3 randomized controlled trial for CB-010, an allogeneic anti-CD19 CAR-T cell therapy in development for patients with second-line relapsed or refractory large B cell lymphoma, or r/r LBCL. The FDA stated that Caribou’s proposed comparator arm of platinum-based immunochemotherapy followed by high dose chemotherapy, or HDCT, and autologous stem cell transplantation, or ASCT, is acceptable. In the ongoing ANTLER Phase 1 trial, Caribou is enrolling second-line LBCL patients in the dose expansion portion based on promising data from the dose escalation portion of the trial. Currently, 22 sites are active in the U.S. and the first international site is active in Australia, with additional site activation underway in the U.S. and globally. To Caribou’s knowledge, CB-010 is the first anti-CD19 allogeneic CAR-T cell therapy to be evaluated in the second-line LBCL setting and it has been granted Regenerative Medicine Advanced Therapy, or RMAT, Fast Track, and Orphan Drug designations by the FDA. In Q2, the company plans to report initial dose expansion data from the ANTLER trial and share the recommended Phase 2 dose for CB-010. Caribou plans to initiate a Phase 3 pivotal trial with this RP2D by year-end 2024.