Caribou Biosciences, Inc. (NASDAQ: CRBU) shares ducked soon after Monday’s opening, as the company, a leading clinical-stage CRISPR genome-editing biopharmaceutical company, today reported new 12-month clinical data from cohort 1 in the ongoing ANTLER Phase 1 trial, which show long-term durability following a single infusion of CB-010 at the initial dose level 1 (40x106 CAR-T cells). Cohort 1 results show:
• six of six patients achieved a complete response (CR) as best response
• three of six patients maintained a durable CR at six months
• two of six patients maintain a long-term CR at the 12-month scan and remain on the trial
• 18 months is the longest CR maintained to date in ANTLER, achieved by the first patient dosed with CB-010
• CB-010 was generally well tolerated with adverse events consistent with autologous or allogeneic anti-CD19 CAR-T cell therapies
Based on promising initial data, the U.S. Food and Drug Administration granted CB-010 both Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations. In addition, Caribou has observed an encouraging safety profile for CB-010 at dose level 2 (80x106 CAR-T cells) with no dose-limiting toxicities (DLTs) in the three patients treated and is currently enrolling patients at dose level 3 (120x106 CAR-T cells).
Caribou expects to provide an ANTLER trial update in 2023.
CB-010 is the first allogeneic anti-CD19 CAR-T cell therapy in the clinic with a PD-1 knockout, a genome-editing strategy designed to improve the persistence of antitumor activity by limiting premature CAR-T cell exhaustion.
CRBU shares stumbled $1.20, or 13.3%, to begin Monday at $7.78.
