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Caribou Biosciences Discusses Vispacel Clinical Data and Pivotal Trial Plans at ASH 2025
CRBU
Product Launch
New Projects/Investments
- Caribou Biosciences presented clinical data for Vispacel, an off-the-shelf CAR T cell therapy targeting CD19 for large B cell lymphoma, demonstrating outcomes on par with auto CAR Ts and a generally well-tolerated safety profile suitable for outpatient and community settings.
- Vispacel is focused on addressing the significant unmet need in second-line large B cell lymphoma patients, particularly the approximately 60% who are dual ineligible for autologous CAR T and auto stem cell transplant due to clinical and real-world barriers.
- Physicians highlighted that only 25% of fit second-line patients currently receive CAR T therapy, underscoring the access issues that Vispacel's off-the-shelf nature could resolve by providing timely treatment, especially for those with rapidly progressive disease.
- Caribou's pivotal study for Vispacel will be a randomized controlled Phase 3 trial in second-line large B cell lymphoma patients who are ineligible for auto CAR T and auto stem cell transplant.
2 days ago
Caribou Biosciences Provides Positive Clinical Updates and Pivotal Trial Strategy for Vispa-cel
CRBU
Product Launch
New Projects/Investments
- Caribou Biosciences reported that its allogeneic CAR-T therapy, Vispa-cel (CD19), demonstrated clinical outcomes (overall response rates, complete response rates, and duration of response) nearly identical to autologous CAR-T in a subset of 84 treated patients with young donor, partially HLA-matched product, alongside a favorable safety profile.
- The company plans a pivotal trial for Vispa-cel in approximately 250 auto CAR-T and auto transplant ineligible patients, randomized against immunochemotherapy, targeting a significant unmet need as 75% of large cell B-cell lymphoma patients do not receive auto CAR-T.
- Vispa-cel is differentiated by a PD-1 knockout to prevent premature CAR-T cell exhaustion and offers commercial advantages, including immediate availability, requiring only 10 batches for 98% HLA matching, with projected COGS 96% lower than auto CAR-Ts at launch.
- For its CB-011 (BCMA) program in myeloma, Caribou Biosciences intends to expand the 450 million cell cohort to approximately 30 patients to further evaluate overall response rates, depth of remission, and MRD negativity, aiming to demonstrate median PFS in the 15-month range to compete with bispecifics.
6 days ago
Caribou Biosciences Discusses Promising Allogeneic CAR-T Programs Vispa-cel and CB-011
CRBU
New Projects/Investments
Product Launch
- Caribou Biosciences' allogeneic CAR-T therapy, Vispa-cel (CD19 program), has demonstrated efficacy and safety profiles "nearly identical to auto CAR-T" in a subset of patients, addressing a significant unmet need for the 75% of large cell B-cell lymphoma patients who do not receive auto CAR-T.
- A pivotal trial for Vispa-cel is planned for a dual ineligible population (auto CAR-T and auto transplant ineligible) randomized against immunochemotherapy, enrolling approximately 250 patients with a PFS endpoint. The product is differentiated by a PD-1 knockout to prevent T-cell exhaustion, contributing to its clinical success.
- For the CB-011 (BCMA program for myeloma), the company aims for efficacy comparable to bispecifics, with plans to expand the 450 million cell cohort to approximately 30 patients to further evaluate response rates and MRD negativity.
- Vispa-cel offers significant logistical advantages as an off-the-shelf product, with a commercial-ready scale process producing 200-300 doses per batch and projected COGS 96% lower than auto CAR-Ts at launch.
6 days ago
Caribou Biosciences Provides Updates on Vispacel and CB-011 Clinical Programs
CRBU
Product Launch
New Projects/Investments
Guidance Update
- Caribou Biosciences' Vispacel (CD19) program has demonstrated auto CAR-T-like efficacy in a subset of 84 patients, showing similar overall response rates, complete response rates, and duration of response, coupled with a favorable safety profile characterized by very low rates of cytokine release syndrome, high-grade neurotoxicity, and severe infections.
- Vispacel is being developed for the auto CAR-T ineligible and auto transplant ineligible patient population, which represents approximately 75% of large cell B-cell lymphoma patients who currently do not receive auto CAR-T. This population constitutes about half of the second-line setting.
- A key differentiator for Vispacel is its PD-1 knockout using chRDNA technology, designed to prevent premature CAR-T cell exhaustion and contribute to clinical success.
- Vispacel is an off-the-shelf product that can be manufactured at a commercial-ready scale, yielding 200-300 doses per batch, and is projected to have 96% lower COGS than auto CAR-Ts at launch.
- For the CB-011 (BCMA) program in myeloma, Caribou plans to expand the 450 million cell cohort to approximately 30 patients to provide better estimates of overall response rate, complete remission, and MRD negativity, with a target to show median PFS in the 15-month range.
6 days ago
Caribou Biosciences Reports Q3 2025 Financial Results and Positive Clinical Data
CRBU
Earnings
New Projects/Investments
Guidance Update
- Caribou Biosciences reported $159.2 million in cash, cash equivalents, and marketable securities as of September 30, 2025, which is expected to fund its operating plan into 2H 2027.
- For the third quarter of 2025, licensing and collaboration revenue was $2.2 million, and the net loss was $27.5 million or $0.30 per share.
- Positive clinical data from the ANTLER phase 1 trial for vispa-cel (CB-010) demonstrated an 82% overall response rate (ORR) and 64% complete response (CR) rate in the confirmatory cohort, with plans for a pivotal phase 3 trial.
- First clinical data for CB-011 from the CaMMouflage phase 1 trial showed a 92% ORR and 75% ≥CR in the BCMA-naïve cohort at the recommended dose for expansion, with dose expansion planned by the end of 2025.
Nov 12, 2025, 9:08 PM
Caribou Biosciences Provides Positive Clinical Updates on CAR-T Cell Therapy Programs
CRBU
Product Launch
New Projects/Investments
- Caribou Biosciences (CRBU) reported positive clinical updates for its off-the-shelf CAR-T cell therapy programs, Vispa-cel (CB-010) for relapsed or refractory large B cell lymphoma (r/r LBCL) and CB-011 for relapsed or refractory multiple myeloma (r/r MM) on November 3, 2025.
- For Vispa-cel, optimized product data in r/r LBCL demonstrated an 86% Overall Response Rate (ORR), a 63% Complete Response (CR) rate, and 53% 12-month Progression-Free Survival (PFS), with efficacy and durability on par with autologous CAR-T cell therapies. A pivotal trial in 2L LBCL is planned.
- Vispa-cel also exhibited a generally well-tolerated safety profile, with no GvHD or Grade 3+ ICANS and less than 5% Grade 3+ CRS, which could enable outpatient use.
- For CB-011 in BCMA-naïve r/r MM patients at the recommended dose for expansion (RDE), results included a 92% ORR, a 75% ≥CR rate, and 91% MRD negativity, alongside a manageable safety profile with no GvHD observed.
- Caribou plans to initiate dose expansion for CB-011 at the 450M cell dose in the CaMMouflage Phase 1 trial.
Nov 3, 2025, 1:00 PM
Caribou Biosciences Reports Positive Clinical Data for Vispa-cel and CB-011
CRBU
Product Launch
New Projects/Investments
Guidance Update
- Caribou Biosciences (CRBU) reported positive clinical data on November 3, 2025, for two off-the-shelf CAR-T cell therapy programs: vispacabtagene regedleucel (vispa-cel) for relapsed or refractory B-cell non-Hodgkin lymphoma and CB-011 for relapsed or refractory multiple myeloma.
- In the ATLAS phase I trial, vispa-cel's 35-patient optimized profile cohort achieved an 86% overall response rate (ORR) and a 63% complete response (CR) as of September 29, 2025, with a generally well-tolerated safety profile and no graft versus host disease.
- For CB-011, the CAMOUFLAGE phase I trial demonstrated a 92% ORR and 75% CR or stringent CR in 12 BCMA naive patients at the recommended dose for expansion, showing a manageable safety profile and encouraging durability.
- Caribou plans to initiate a randomized controlled Phase 3 pivotal trial for vispa-cel in second-line large B-cell lymphoma and expects to initiate CB-011 dose expansion by the end of 2025, with a data readout on dose expansion and longer follow-up on dose escalation in 2026.
- Both therapies are projected to have significantly lower costs of goods sold (COGS) at launch compared to autologous CAR-T cell therapies, with vispa-cel estimated to be 96% lower and CB-011 80% lower.
Nov 3, 2025, 1:00 PM
Caribou Biosciences Announces Positive Clinical Data for Vispa-cel and CB-011, and Preliminary Q3 2025 Financials
CRBU
Product Launch
New Projects/Investments
Guidance Update
- Caribou Biosciences reported positive data from its ANTLER Phase 1 trial for vispa-cel (CB-010) in relapsed or refractory large B cell lymphoma, with the optimized profile cohort demonstrating an 86% overall response rate (ORR), 63% complete response (CR) rate, and 53% 12-month progression-free survival (PFS) as of September 29, 2025.
- The company plans a randomized, controlled pivotal Phase 3 trial for vispa-cel in second-line large B cell lymphoma, expecting to enroll approximately 250 patients.
- Positive data was also announced from the CaMMouflage Phase 1 trial for CB-011 in relapsed or refractory multiple myeloma, showing a 92% ORR, 75% ≥CR rate, and 91% MRD negativity in the 12-patient, BCMA-naïve cohort as of September 24, 2025. Dose expansion for CB-011 is expected to initiate by year-end 2025, with data anticipated in 2026.
- Preliminary unaudited cash, cash equivalents, and marketable securities were approximately $159.2 million as of September 30, 2025.
Nov 3, 2025, 12:02 PM
Caribou Biosciences Announces Positive Clinical Data for CB-011
CRBU
New Projects/Investments
- Caribou Biosciences announced positive first clinical data from the dose escalation in the CaMMouflage phase 1 trial for CB-011, an allogeneic anti-BCMA CAR-T cell therapy for relapsed or refractory multiple myeloma (r/r MM).
- The 450 million cell dose is the recommended dose for expansion (RDE), with dose expansion expected to initiate by year-end and data anticipated in 2026.
- In the 12-patient, BCMA-naïve cohort treated at the RDE with the selected lymphodepletion regimen, CB-011 demonstrated a 92% overall response rate (ORR), a 75% ≥complete response (CR) rate, and 91% minimal residual disease (MRD) negativity.
- CB-011 exhibited a manageable safety profile across all dose levels and lymphodepletion regimens, with no cases of graft-versus-host disease (GvHD), immune effector cell-associated enterocolitis (IEC-EC), parkinsonism, or cranial nerve palsies.
Nov 3, 2025, 12:00 PM
Caribou Biosciences to Report New Clinical Data and Trial Designs
CRBU
New Projects/Investments
- Caribou Biosciences will host a webcast on Monday, November 3, 2025, at 8:00 am ET to report new clinical data.
- The webcast will include new data from the ANTLER phase 1 clinical trial evaluating vispacabtagene regedleucel (vispa-cel) in relapsed or refractory B cell non-Hodgkin lymphoma (r/r B-NHL).
- It will also report the first clinical data from the CaMMouflage Phase 1 clinical trial evaluating CB-011 in relapsed or refractory multiple myeloma (r/r MM).
- Additionally, the company will report its anticipated pivotal phase 3 trial design for vispa-cel and next steps for the continued clinical development of CB-011.
Nov 2, 2025, 9:00 PM
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