Clinical Trials and Programs - Caribou Biosciences initiated the GALLOP Phase 1 clinical trial for CB-010 in patients with lupus nephritis (LN) and extrarenal lupus (ERL) [1][5] - The AMpLify Phase 1 trial for CB-012 in relapsed or refractory acute myeloid leukemia (r/r AML) completed dose level 3 with no dose-limiting toxicities (DLTs) and is enrolling patients at dose level 4 [1][11] - Clinical data from the ANTLER Phase 1 trial for CB-010 in second-line large B cell lymphoma (2L LBCL) and the CaMMouflage Phase 1 trial for CB-011 in relapsed or refractory multiple myeloma (r/r MM) are expected in H1 2025 [1][12] - Caribou plans to initiate a pivotal Phase 3 trial for CB-010 in 2L LBCL in H2 2025, pending confirmation of the HLA matching strategy [2][5] Corporate Updates - Sri Ryali was appointed as the new chief financial officer [1][11] - Caribou reported $281 million in cash, cash equivalents, and marketable securities as of September 30, 2024, providing a cash runway into H2 2026 [8] - The company expanded its leadership team with the appointments of Tim Kelly as chief technology officer and Tina Albertson, MD, PhD, as chief medical officer [11] Regulatory and Designations - CB-010 received Fast Track designation from the FDA for refractory systemic lupus erythematosus (SLE) and Regenerative Medicine Advanced Therapy (RMAT) and Orphan Drug designations for B cell non-Hodgkin lymphoma (B-NHL) [5][13] - CB-011 and CB-012 were granted Fast Track and Orphan Drug designations by the FDA for their respective indications [11][14][15] Scientific and Clinical Highlights - CB-010 demonstrated potential to match the safety, efficacy, and durability of approved autologous CAR-T cell therapies in the ANTLER Phase 1 trial [5] - Patients with ≥4 matching HLA alleles showed improved progression-free survival (PFS) in the ANTLER trial, prompting further enrollment to confirm the HLA matching strategy [5] - CB-011 is the first allogeneic CAR-T cell therapy with an immune cloaking strategy using a B2M knockout and B2M–HLA-E fusion protein insertion [14] - CB-012 is the first allogeneic CAR-T cell therapy with both checkpoint disruption (PD-1 knockout) and immune cloaking (B2M knockout and B2M–HLA-E fusion protein insertion) [15] Upcoming Events - Caribou will present at the 43rd Annual J P Morgan Healthcare Conference on January 16, 2025, at 10:30 am PST [1][10]
Caribou Biosciences Initiates the CB-010 GALLOP Phase 1 Trial in Lupus and Provides Outlook for Multiple Clinical Datasets in 2025