CB-011 / Caribou Biosci - LARVOL DELTA

Caribou Biosciences…announced that it will hold a webcast beginning at 8:00 am ET on Monday, November 3, 2025… (GlobeNewswire) - "Caribou Biosciences...to report new data from the ANTLER phase 1 clinical trial evaluating vispacabtagene regedleucel (vispa-cel; formerly CB-010), an allogeneic anti-CD19 CAR-T cell therapy, in patients with relapsed or refractory B cell non-Hodgkin lymphoma (r/r B-NHL) and report the first clinical data from the CaMMouflage Phase 1 clinical trial evaluating CB-011, an allogeneic anti-BCMA CAR-T cell therapy, in patients with r/r multiple myeloma. The Company will also report its anticipated pivotal phase 3 trial design for vispa-cel and next steps for the continued clinical development of CB-011."

New P3 trial • P1 data • B Cell Non-Hodgkin Lymphoma • Multiple Myeloma

Caribou Biosciences Announces Positive Data from CaMMouflage Phase 1 Trial of CB-011 in Multiple Myeloma (The Manila Times) - "The Company is advancing the program into dose expansion, which it expects to initiate by the end of this year, and the Company plans to share dose expansion data in 2026....92% (11/12) overall response rate (ORR); 75% (9/12) ≥complete response (CR) rate; 91% (10/11 evaluable patients) achieved minimal residual disease (MRD) negativity (≤10-5); 7 of 12 patients remained on study as of the data cutoff date in ≥very good partial response (VGPR) 6 months or longer following receipt of a single dose of CB-011."

P1 data • Trial status • Multiple Myeloma

CaMMouflage: CRISPR-Edited Allogeneic Anti-BCMA CAR-T Cell Therapy in Patients With Relapsed/Refractory Multiple Myeloma (clinicaltrials.gov) - P1 | N=50 | Recruiting | Sponsor: Caribou Biosciences, Inc. | Trial completion date: Feb 2027 ➔ Dec 2027 | Trial primary completion date: May 2025 ➔ Dec 2027

Trial completion date • Trial primary completion date • Hematological Malignancies • Multiple Myeloma • Oncology

Caribou Biosciences Announces Strategic Pipeline Prioritization with Focus on CB-010 and CB-011 Oncology Programs (GlobeNewswire) - "2025 anticipated milestones:...CB-011 CaMMouflage: Caribou plans to present dose escalation data and share the recommended doses for expansion from the ongoing CaMMouflage Phase 1 clinical trial in r/r MM in H2 2025. This update is expected to include: (i) Initial safety and efficacy data on a minimum of 25 patients at multiple dose levels using the deeper lymphodepletion regimen with at least three months of follow up; (ii) Recommended doses for expansion and plans for dose expansion."

P1 data • Multiple Myeloma

Caribou Biosciences Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Update (GlobeNewswire) - "2025 anticipated milestones: (i) CB-010 ANTLER: Caribou plans to present data from both the additional 2L and prior CD19 relapsed LBCL patient cohorts in H1 2025. Caribou plans to initiate a pivotal Phase 3 clinical trial in H2 2025 should data confirm the initial observation that partial HLA matching drives outcomes that are on par with autologous CAR-T cell therapies. The Phase 3 trial would be initiated after agreement with the FDA on a pivotal trial design; (ii) CB-011 CaMMouflage: Caribou plans to present dose escalation data on a minimum of 15 patients at active dose levels from the ongoing CaMMouflage Phase 1 clinical trial in r/r MM in H1 2025; (iii) CB-012 AMpLify: Caribou plans to provide updates on dose escalation as the AMpLify Phase 1 clinical trial in r/r AML advances."

New P3 trial • P1 data • Acute Myelogenous Leukemia • Large B Cell Lymphoma • Multiple Myeloma

Caribou Biosciences Reports Third Quarter 2024 Financial Results and Provides Business Update (GlobeNewswire) - "Anticipated milestones: (i) CB-011 CaMMouflage: Caribou plans to present dose escalation data from the ongoing CaMMouflage Phase 1 clinical trial in r/r MM in H1 2025; (i1) CB-012 AMpLify: Caribou plans to provide updates on dose escalation as the AMpLify Phase 1 clinical trial in r/r AML advances."

P1 data • Acute Myelogenous Leukemia • Multiple Myeloma

Caribou Biosciences Reports Second Quarter 2024 Financial Results and Provides Business Update (Caribou Bio Press Release) - "CB-011: Caribou is enrolling patients with relapsed or refractory multiple myeloma (r/r MM) in the dose escalation portion of the ongoing CaMMouflage Phase 1 clinical trial; Caribou plans to present initial dose escalation data from the ongoing CaMMouflage Phase 1 clinical trial by year-end 2024....Research and development expenses were $35.5 million for the three months ended June 30, 2024, compared to $26.5 million for the same period in 2023. The increase was primarily due to costs to advance pipeline programs, including the CB-010 ANTLER, CB-011 CaMMouflage, and CB-012 AMpLify Phase 1 clinical trials..."

Commercial • P1 data • Trial status • Acute Myelogenous Leukemia • Hematological Malignancies • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology

Caribou cuts NK cell therapy program, lays off 12% of staff to fund CAR-T priorities (FierceBiotech) - "The CAR-NK program, dubbed CB-020, was an induced pluripotent stem cell (iPSC)-derived allogeneic anti-ROR 1 cell therapy aimed at solid tumors. Caribou already revealed in March that it had paused work on the program as part of a 'regular portfolio prioritization process...With the NK plans now abandoned altogether, the biotech can focus its resources on its allogeneic CAR-T platform, which Caribou noted yesterday has 'multiple milestones expected in 2024 and 2025' across its oncology and autoimmune arms...These include presenting initial dose escalation data for CB-011 in relapsed or refractory multiple myeloma by the end of this year, as well as launching a phase 1 trial of its lead asset CB-010—which is already being tested in B cell lymphoma—in lupus."

Discontinued • New P1 trial • P1 data • Lupus • Multiple Myeloma • Solid Tumor

Caribou Biosciences Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update (Caribou Bio Press Release) - "2024 anticipated milestones: (i) CB-010: In Q2 2024, Caribou plans to present initial dose expansion data, the recommended Phase 2 dose (RP2D), and emerging translational data from the ANTLER Phase 1 clinical trial; (ii) CB-011: Caribou plans to present initial dose escalation data from the CaMMouflage Phase 1 clinical trial by year-end 2024; (iii) CB-012: Caribou plans to provide updates on dose escalation as the AMpLify Phase 1 clinical trial in r/r AML advances."

P1 data • Acute Myelogenous Leukemia • Multiple Myeloma • Non-Hodgkin’s Lymphoma

High-specificity CRISPR-mediated genome engineering in anti-BCMA allogeneic CAR T cells suppresses allograft rejection in preclinical models. (PubMed, Cancer Immunol Res) - P1 | "CB-011 cells were protected from natural killer (NK) cell-mediated cytotoxicity in vitro and in vivo due to endogenous promoter-driven expression of B2M-HLA-E. Potent antitumor efficacy, when combined with an immune-cloaking armoring strategy to dampen allograft rejection, offers optimized therapeutic potential in multiple myeloma."

CAR T-Cell Therapy • IO biomarker • Journal • Preclinical • Graft versus Host Disease • Hematological Malignancies • Immunology • Multiple Myeloma • Oncology • Transplant Rejection • B2M • HLA-E

Caribou Biosciences Appoints Tim Kelly as Chief Technology Officer and Highlights Multiple Clinical Catalysts Expected in 2024 (ET Healthworld) - P1 | N=50 | CaMMouflage (NCT05722418) | Sponsor: Caribou Biosciences, Inc. | "CB-011, an allogeneic anti-BMCA CAR-T cell therapy for multiple myeloma...CaMMouflage trial enrollment has concluded for dose level 1 (50x10⁶ CAR-T cells, N=3) and dose level 2 (150x10⁶ CAR-T cells, N=3) without any dose-limiting toxicities (DLTs), and the trial is enrolling patients at dose level 3 (450x10⁶ CAR-T cells)...The first clinical sites are active for the AMpLify Phase 1 trial for CB-012 in r/r AML with additional site activation underway....CB-011: Caribou plans to report initial dose escalation data by year-end 2024."

Enrollment status • P1 data • Trial status • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Multiple Myeloma • Oncology

Orphan Designation: Treatment of Multiple Myeloma (FDA) - Date Designated: 11/22/2023

Orphan drug • Hematological Malignancies • Multiple Myeloma • Oncology

Caribou Biosciences Reports Third Quarter 2023 Financial Results and Provides Business Update (Caribou Bio Press Release) - "CB-010: Caribou plans to meet with the FDA to discuss a potential pivotal clinical trial in second-line LBCL patients and plans to share FDA feedback by year-end 2023. The Company also plans to report initial dose expansion data in second-line LBCL patients from the ongoing ANTLER trial in H1 2024; CB-011: Caribou plans to provide updates on dose escalation as the CaMMouflage Phase 1 clinical trial in r/r MM advances; CB-012: Caribou plans to initiate patient enrollment in the AMpLify Phase 1 clinical trial in r/r AML by mid-2024."

Enrollment status • FDA event • P1 data • Acute Myelogenous Leukemia • Hematological Malignancies • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology

Caribou Biosciences Reports Second Quarter 2023 Financial Results and Provides Business Update (GlobeNewswire) - "CB-010: Caribou plans to meet with the FDA to discuss a potential pivotal clinical trial in second-line LBCL patients and plans to share FDA feedback by YE 2023. The Company also plans to report initial dose expansion data in second-line LBCL patients from the ongoing ANTLER trial in H1 2024; CB-011: Caribou plans to provide updates on dose escalation as the CaMMouflage Phase 1 clinical trial in r/r MM advances; CB-012: Caribou plans to submit an IND application for r/r AML in H2 2023."

FDA event • IND • P1 data • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology

Caribou Biosciences Announces $25 Million Equity Investment from Pfizer (GlobeNewswire) - "Caribou will use the proceeds of this investment to advance CB-011, an immune cloaked allogeneic CAR-T cell therapy currently being evaluated in the CaMMouflage Phase 1 clinical trial in patients with relapsed or refractory multiple myeloma (r/r MM)."

Commercial • Hematological Malignancies • Multiple Myeloma • Oncology

A first-in-human phase 1, multicenter, open-label study of CB-011, a next-generation CRISPR-genome edited allogeneic anti-BCMA immune-cloaked CAR-T cell therapy, in patients with relapsed/refractory multiple myeloma (CAMMOUFLAGE trial). (ASCO 2023) - P1 | "After concurrently receiving lymphodepletion therapy with cyclophosphamide (300 mg/m2/d) and fludarabine (30 mg/m2/d) for 3 days, patients receive a single dose infusion of CB-011 and are followed for safety and efficacy. The CaMMouflage Phase 1 trial is actively enrolling patients and additional information is available on clinicaltrials.gov (NCT05722418). Clinical trial information: NCT05722418."

CAR T-Cell Therapy • Clinical • IO biomarker • P1 data • Graft versus Host Disease • Hematological Malignancies • Immunology • Multiple Myeloma • Oncology • B2M • HLA-E

Caribou Biosciences Announces FDA Granted Fast Track Designation to CB-011, an Allogeneic CAR-T Cell Therapy for Relapsed or Refractory Multiple Myeloma (GlobeNewswire) - "Caribou Biosciences, Inc...today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to CB-011, which is being developed for relapsed or refractory multiple myeloma (r/r MM)."

Fast track designation • Hematological Malignancies • Multiple Myeloma • Oncology

Caribou Biosciences Announces Dosing of First Patient in the CaMMouflage Phase 1 Trial of CB-011, an Allogeneic Anti-BCMA CAR-T Cell Therapy for the Treatment of Relapsed or Refractory Multiple Myeloma (GlobeNewswire) - "Caribou Biosciences, Inc...announced the first patient has been dosed with CB-011 at dose level 1 (50x106 CAR-T cells) in the CaMMouflage Phase 1 trial for adults with relapsed or refractory multiple myeloma (r/r MM). CB-011 is an allogeneic anti-BCMA CAR-T cell therapy designed to improve antitumor activity by reducing T and natural killer (NK) cell-mediated rejection....Caribou plans to continue to enroll additional patients at dose level 1 in the CaMMouflage trial and provide an update on the clearance of dose levels as appropriate."

Trial status • Hematological Malignancies • Multiple Myeloma • Oncology

Caribou Biosciences Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Business Update (GlobeNewswire) - "CB-010: Caribou plans to provide an update from the ongoing ANTLER Phase 1 trial for CB-010 in H2 2023; CB-011: Caribou recently activated clinical sites for the recruitment of patients at dose level 1 and plans to provide an update on the clearance of dose levels as appropriate from the CaMMouflage Phase 1 trial for CB-011; CB-012: Caribou plans to submit an IND application for CB-012 in H2 2023."

IND • P1 data • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology

CB-011, a BCMA-Specific Allogeneic CAR-T Cell Therapy, Engineered with Next-Generation CRISPR Technology to Express an HLA-E Fusion Transgene to Prevent Immune Cell-Mediated Rejection, for r/r Multiple Myeloma (TCT-ASTCT-CIBMTR 2023) - "These studies support the safety and efficacy profiles of CB-011 for an upcoming first-in-human phase 1 clinical trial evaluating these allogeneic BCMA-specific CAR-T cells in patients with r/r MM."

CAR T-Cell Therapy • Immune cell • IO biomarker • Graft versus Host Disease • Hematological Malignancies • Immunology • Multiple Myeloma • Oncology • B2M • CD19 • HLA-E

CaMMouflage: CRISPR-Edited Allogeneic Anti-BCMA CAR-T Cell Therapy in Patients With Relapsed/Refractory Multiple Myeloma (clinicaltrials.gov) - P1 | N=50 | Recruiting | Sponsor: Caribou Biosciences, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Hematological Malignancies • Multiple Myeloma • Oncology

CaMMouflage: CRISPR-Edited Allogeneic Anti-BCMA CAR-T Cell Therapy in Patients With Relapsed/Refractory Multiple Myeloma (clinicaltrials.gov) - P1 | N=50 | Not yet recruiting | Sponsor: Caribou Biosciences, Inc.

CAR T-Cell Therapy • New P1 trial • Hematological Malignancies • Multiple Myeloma • Oncology

Caribou Biosciences Announces FDA Clearance of IND Application for CB-011, an Allogeneic Anti-BCMA CAR-T Cell Therapy for the Treatment of Relapsed or Refractory Multiple Myeloma (Yahoo Finance) - "Caribou Biosciences, Inc...today announced that it has received clearance of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) for CB-011....The CaMMouflage Phase 1 clinical trial, a multicenter, open-label study to evaluate the safety and efficacy of a single dose of CB-011 in adult patients with relapsed or refractory multiple myeloma (r/r MM), is expected to initiate patient enrollment for treatment at dose level 1 (50x106 CAR-T cells) in early 2023."

IND • New P1 trial • Hematological Malignancies • Multiple Myeloma • Oncology

Caribou Biosciences Reports Third Quarter 2022 Financial Results and Provides Business Update (GlobeNewswire) - "CB-010: Caribou plans to share additional data from cohort 1 of the ongoing ANTLER Phase 1 trial for CB-010, an allogeneic anti-CD19 CAR-T cell therapy for r/r B-NHL, by YE 2022; CB-011: Caribou anticipates the FDA’s response to Caribou’s IND application for CB-011, an allogeneic anti-BCMA CAR-T cell therapy for r/r MM, by YE 2022."

IND • P1 data • Hematological Malignancies • Lymphoma • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology

Caribou Biosciences Reports Second Quarter 2022 Financial Results and Provides Business Update (GlobeNewswire) - "Anticipated Milestones for 2022 and Beyond: CB-010: Caribou plans to share additional data from cohort 1 of the ongoing ANTLER Phase 1 trial for CB-010, an anti-CD19 CAR-T cell therapy for r/r B-NHL, by YE 2022; CB-011: Caribou expects to submit an IND application for CB-011, an anti-BCMA CAR-T cell therapy for relapsed or refractory multiple myeloma (r/r MM), in Q4 2022."

IND • P1 data • Hematological Malignancies • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology