Summary of Caribou Biosciences Update - November 03, 2025 Company Overview - **Company**: Caribou Biosciences (NasdaqGS:CRBU) - **Focus**: Development of allogeneic CAR-T cell therapies, specifically vispacabtagene regedleucel (vispa-cel) for B-cell non-Hodgkin lymphoma and CB-011 for multiple myeloma Key Clinical Updates - **Clinical Trials**: - **ATLAS Phase I Trial**: Evaluating vispacabtagene regedleucel in patients with relapsed or refractory B-cell non-Hodgkin lymphoma - **CAMOUFLAGE Phase I Trial**: Evaluating CB-011 in patients with relapsed or refractory multiple myeloma - **Positive Data**: Both trials reported positive clinical data, indicating promising efficacy and safety profiles for the therapies [2][4][9] Core Findings - **Efficacy of vispacabtagene regedleucel**: - Overall response rate of 86% and complete response rate of 63% in the optimized cohort - 53% progression-free survival at 12 months [14][29] - Efficacy comparable to autologous CAR-T therapies, with no graft versus host disease reported [14][25] - **Efficacy of CB-011**: - 92% overall response rate with 75% achieving complete response in the dose escalation cohort - 91% of evaluable patients achieved minimal residual disease (MRD) negativity [40][42] Safety Profile - **Vispacabtagene regedleucel**: - Generally well-tolerated with no grade three or higher neurotoxicity observed - Manageable rates of infections and prolonged cytopenias [14][25][29] - **CB-011**: - No graft versus host disease, colitis, or cranial nerve palsy observed - Manageable adverse events with lower rates of infections compared to other therapies [40][42] Manufacturing and Cost Efficiency - **Manufacturing Capacity**: - Each batch of vispacabtagene regedleucel can yield 200-300 doses, with a single facility capable of producing up to 9,000 doses per year [10][36] - **Cost of Goods Sold**: - Projected to be approximately 96% lower than autologous CAR-T therapies at launch [11][36] Market Opportunity - **Target Population**: - Approximately 10,000 second-line large B-cell lymphoma patients in the US, with a significant portion being transplant-ineligible and auto CAR-T ineligible [35][36] - **Growth Potential**: - The large B-cell lymphoma market is expected to double by 2033, indicating a substantial commercial opportunity for vispacabtagene regedleucel [35] Future Plans - **Pivotal Trial**: - Plans to conduct a randomized controlled trial for vispacabtagene regedleucel in second-line large B-cell lymphoma patients who are CD19 naive and ineligible for transplant or autologous CAR-T therapy [30][31] - **Community Access**: - Strategy to leverage community sites for broader patient access, addressing barriers to CAR-T therapy [33][34] Additional Insights - **Key Opinion Leaders**: - Discussions with clinicians highlighted the need for improved access to CAR-T therapies and the potential of vispacabtagene regedleucel to meet this need [54][59] - **Patient-Centric Approach**: - Emphasis on the importance of rapid treatment initiation and the elimination of manufacturing delays associated with autologous therapies [10][58] This summary encapsulates the critical updates and insights from Caribou Biosciences' recent conference call, focusing on their innovative CAR-T therapies and the potential impact on patient care and market dynamics.