FDA clears Caribou’s IND application for CB-010 to treat lupus and ERL

Caribou Biosciences announced that it received clearance of its Investigational New Drug, IND, application from the U.S. Food and Drug Administration FDA for CB-010, an allogeneic anti-CD19 CAR-T cell therapy with a PD-1 knockout KO, for the treatment of lupus nephritis LN and extrarenal lupus ERL. The Phase 1, multicenter, open label GALLOP clinical trial of CB-010 in patients with LN and ERL is expected to initiate by year-end 2024. “CB-010 has demonstrated encouraging initial safety and efficacy in patients with relapsed or refractory B cell non-Hodgkin lymphoma, and we are excited to expand CB-010’s clinical development to include autoimmune diseases,” said Rachel Haurwitz, PhD, Caribou’s president and chief executive officer. “By targeting CD19-positive B cells involved in the production of autoantibodies and the perpetuation of the autoimmune response, our off-the-shelf CAR-T cell therapy CB-010 has the potential to greatly improve the standard of care for patients with lupus, a prevalent and severe autoimmune disease.” CB-010 is the lead clinical-stage product candidate from Caribou’s allogeneic CAR-T cell therapy platform. As previously reported, CB-010 has demonstrated encouraging initial safety and efficacy from the dose escalation portion of the ongoing ANTLER Phase 1 trial in patients with relapsed or refractory B cell non-Hodgkin lymphoma r/r B-NHL . Caribou continues to enroll patients with large B cell lymphoma LBC in the second-line setting, and initial dose expansion data from ANTLER will be presented at a medical congress in Q2. “Despite treatment advancements, fatigue, organ damage, and low health-related quality of life often remain life-long characteristics of lupus,” said Richard Lafayette, MD, professor of medicine, Stanford Medicine Health Care. “An allogeneic anti-CD19 CAR-T cell therapy from healthy donor T cells has the potential to revolutionize lupus treatment, offering a readily available treatment for patients who need new therapeutic options.” Caribou continues to expect the $372.4M cash, cash equivalents, and marketable securities, as of December 31 to fund the current operating plan into Q1 2026.