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Caribou Biosciences Announces Positive Data from CaMMouflage Phase 1 Trial of CB-011 in Multiple Myeloma
Globenewswire· 2025-11-03 12:00
Core Insights - Caribou Biosciences, Inc. announced promising clinical data from the CaMMouflage phase 1 trial for CB-011, an allogeneic CAR-T cell therapy targeting relapsed or refractory multiple myeloma, indicating its potential as a best-in-class treatment option [1][3][5] Company Overview - Caribou Biosciences is a clinical-stage CRISPR genome-editing biopharmaceutical company focused on developing transformative therapies for severe diseases, with a particular emphasis on CAR-T cell therapies [9] Clinical Trial Details - The CaMMouflage phase 1 trial is evaluating CB-011 in adults with relapsed or refractory multiple myeloma who have undergone three or more prior therapies, utilizing a 3+3 dose escalation design [8] - The trial included 48 patients, with a recommended dose for expansion (RDE) set at 450 million CAR-T cells, and the dose expansion phase is expected to begin by the end of 2025 [3][8] Efficacy and Safety Data - In the RDE cohort of 12 BCMA-naïve patients, the overall response rate (ORR) was 92% (11/12), with a complete response (CR) rate of 75% (9/12) and 91% (10/11) achieving minimal residual disease (MRD) negativity [4][3] - The safety profile of CB-011 was manageable, with no cases of graft-versus-host disease or severe immune-related complications reported [2][4] Future Plans - The company plans to share additional data from the dose expansion phase in 2026, following the initiation of this phase by the end of 2025 [1][5]
Caribou Biosciences Announces Positive Data from ANTLER Phase 1 Trial Demonstrating Efficacy and Durability of Vispa-cel (CB-010), an Allogeneic CAR-T Cell Therapy, on Par with Autologous CAR-T Cell Therapies
Globenewswire· 2025-11-03 12:00
Core Insights - Caribou Biosciences, Inc. announced positive results from the ANTLER phase 1 clinical trial for vispacabtagene regedleucel (vispa-cel), an allogeneic anti-CD19 CAR-T cell therapy for patients with relapsed or refractory B cell non-Hodgkin lymphoma [1][4][8] Clinical Trial Results - The ANTLER trial enrolled 84 patients, with a confirmatory cohort of 22 CD19-naïve second-line large B cell lymphoma patients, demonstrating an 82% overall response rate (ORR), 64% complete response (CR) rate, and 51% progression-free survival (PFS) at 12 months [2][4][5] - In a cohort of 35 patients receiving an optimized profile of vispa-cel, the results showed an 86% ORR, 63% CR rate, and 53% PFS at 12 months, with a median follow-up of 11.8 months [6][4] Safety Profile - Vispa-cel exhibited a generally well-tolerated safety profile, with treatment-emergent adverse events occurring in ≥25% of patients, including thrombocytopenia (62%), cytokine release syndrome (CRS; 55%), and anemia (52%) [7][9] - No cases of graft-versus-host disease (GvHD) or grade 3 immune effector cell-associated neurotoxicity syndrome (ICANS) were reported in the confirmatory and optimized profile cohorts [7][9] Regulatory Path and Future Plans - The FDA has recommended a randomized, controlled phase 3 trial for vispa-cel in second-line large B cell lymphoma, which will evaluate approximately 250 patients [12][8] - The primary endpoint of the upcoming trial will be progression-free survival, with secondary endpoints including overall response rate, complete response rate, and overall survival [12] Company Overview - Caribou Biosciences is focused on developing transformative therapies using its CRISPR genome-editing platform, with vispacabtagene regedleucel being a key candidate for hematologic malignancies [18]
Caribou Biosciences Reports First Quarter 2025 Financial Results and Provides Business Update
Globenewswire· 2025-05-08 20:05
Core Insights - Caribou Biosciences, Inc. is a clinical-stage CRISPR genome-editing biopharmaceutical company focusing on developing allogeneic CAR-T cell therapies for hematologic malignancies, with two lead programs, CB-010 and CB-011, expected to disclose clinical data in H2 2025 [1][2][17] Financial Overview - As of March 31, 2025, Caribou had $212.5 million in cash, cash equivalents, and marketable securities, down from $249.4 million as of December 31, 2024, which is expected to fund operations into H2 2027 [10][21] - Licensing and collaboration revenue for Q1 2025 was $2.4 million, consistent with the same period in 2024 [11] - Research and development expenses increased to $35.5 million in Q1 2025 from $33.8 million in Q1 2024, primarily due to ongoing clinical trials [12] - General and administrative expenses decreased to $9.7 million in Q1 2025 from $14.6 million in Q1 2024, attributed to lower legal and personnel-related expenses [13] - The net loss for Q1 2025 was $40.0 million, slightly improved from a net loss of $41.2 million in Q1 2024 [14] Clinical Program Updates - CB-010 is an allogeneic anti-CD19 CAR-T cell therapy for large B cell lymphoma, while CB-011 is an allogeneic anti-BCMA CAR-T cell therapy for multiple myeloma [3][4] - Caribou is currently enrolling a 20-patient confirmatory cohort in the ANTLER Phase 1 clinical trial for CB-010, with data expected in H2 2025 [7][8] - Encouraging efficacy has been observed in the ongoing CaMMouflage Phase 1 clinical trial for CB-011, with plans to present data in H2 2025 [7][18] Strategic Initiatives - The company has implemented a strategic pipeline prioritization, focusing resources on lead oncology programs and reducing workforce by approximately 32%, which is expected to extend the cash runway by one year [5][10] - Discontinued clinical trials include CB-010 for lupus and CB-012 for relapsed or refractory acute myeloid leukemia, with ongoing follow-up for patients previously treated [5]