vispacabtagene regedleucel (CB-010) / Caribou Biosci - LARVOL DELTA

Caribou Biosciences to Host In-Person and Virtual KOL Event at ASH 2025 (GlobeNewswire) - "KOL panel to discuss how vispa-cel, an anti-CD19 allogeneic CAR-T cell therapy, can broaden access for patients with second-line large B cell lymphoma including through use in the community setting."

Clinical data • Large B Cell Lymphoma

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 (Caribou Bio Press Release) - "Data from this 35-patient cohort further confirmed that the efficacy and durability of vispa-cel are on par with the autologous CAR-T cell therapies. Median follow-up for the optimized profile cohort was 11.8 months, and the longest responding patient, who completed the 2-year ANTLER trial and enrolled in the long-term follow-up study, is in complete response at 3 years post infusion....In all patients treated in ANTLER (N=84), vispa-cel has demonstrated a generally well-tolerated safety profile. As of the September 2, 2025, safety data cutoff date, treatment emergent adverse events at any grade in ≥25% of all patients who received vispa-cel were thrombocytopenia (62%), cytokine release syndrome (CRS; 55%), anemia (52%), neutropenia (39%), hypokalemia (26%), and leukopenia (26%)."

P1 data • B Cell Non-Hodgkin Lymphoma

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

CRISPR-Edited Allogeneic Anti-CD19 CAR-T Cell Therapy, in Patients With Refractory Systemic Lupus Erythematosus (GALLOP) (clinicaltrials.gov) - P1 | N=0 | Withdrawn | Sponsor: Caribou Biosciences, Inc. | N=20 ➔ 0 | Initiation date: Jun 2025 ➔ Dec 2027 | Not yet recruiting ➔ Withdrawn

Enrollment change • Trial initiation date • Trial withdrawal • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Systemic Lupus Erythematosus

Pipeline prioritization with workforce and cost reduction initiatives (GlobeNewswire) - "Caribou is discontinuing the GALLOP Phase 1 trial of CB-010 for lupus prior to dosing the first patient."

Trial termination • Systemic Lupus Erythematosus

Caribou Biosciences Announces Strategic Pipeline Prioritization with Focus on CB-010 and CB-011 Oncology Programs (GlobeNewswire) - "Clinical highlights:...Caribou is enrolling a 20-patient confirmatory cohort using the company’s HLA matching strategy in the ANTLER Phase 1 clinical trial in second-line large B cell lymphoma (2L LBCL). In H2 2025, Caribou expects to present data from this cohort with at least 6 months of follow up for the majority of patients....Additionally, in H2 2025, Caribou expects to present data from a proof-of-concept cohort of CB-010 in up to 10 patients who have relapsed following any prior CD19-targeted therapy....Caribou...is interacting with the FDA on a potential pivotal trial to be initiated following alignment....Pivotal trial design and timeline, contingent on positive data and FDA alignment."

FDA event • P1 data • Large B Cell Lymphoma • Non-Hodgkin’s Lymphoma

CRISPR-Edited Allogeneic Anti-CD19 CAR-T Cell Therapy, in Patients with Refractory Systemic Lupus Erythematosus (GALLOP) (clinicaltrials.gov) - P1 | N=20 | Recruiting | Sponsor: Caribou Biosciences, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Systemic Lupus Erythematosus

Caribou Biosciences Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Update (GlobeNewswire) - "2025 anticipated milestones:...CB-010 GALLOP: Caribou plans to provide updates as the GALLOP Phase 1 clinical trial in LN and ERL advances."

P1 data • Lupus • Lupus Nephritis

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 Initiates the CB-010 GALLOP Phase 1 Trial in Lupus and Provides Outlook for Multiple Clinical Datasets in 2025 (GlobeNewswire) - "Caribou has initiated the GALLOP Phase 1 clinical trial, an open-label, multicenter clinical trial designed to evaluate a single infusion of CB-010 in adult patients with LN and ERL."

Trial status • Lupus • Lupus Nephritis

CRISPR-Edited Allogeneic Anti-CD19 CAR-T Cell Therapy, in Patients with Refractory Systemic Lupus Erythematosus (GALLOP) (clinicaltrials.gov) - P1 | N=20 | Not yet recruiting | Sponsor: Caribou Biosciences, Inc.

New P1 trial • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Systemic Lupus Erythematosus

Preclinical Analysis of CB-010, an Allogeneic anti-CD19 CAR-T Cell Therapy with a PD-1 Knockout, for the Treatment of Patients with Refractory Systemic Lupus Erythematosus (SLE) (ACR Convergence 2024) - P1 | "CB-010, an off-the-shelf CAR-T cell therapy, demonstrated specific B cell targeting in preclinical studies both in vitro and in vivo. The combination of these preclinical data, with a generally well tolerated clinical safety profile and encouraging efficacy from the ongoing ANTLER clinical trial, support the evaluation of CB-010 in a Phase 1 clinical trial for refractory LN and ERL patients (GALLOP). Two patient cohorts (one each in LN and ERL) will be enrolled in parallel using lymphodepletion with fludarabine and cyclophosphamide followed by a single CB-010 infusion of 80 x 106 CAR-T cells (see Figure 3)."

CAR T-Cell Therapy • IO biomarker • Preclinical • Glomerulonephritis • Hematological Malignancies • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Lymphoma • Nephrology • Non-Hodgkin’s Lymphoma • Oncology • Systemic Lupus Erythematosus • CD34 • PD-1

Caribou Biosciences Reports Third Quarter 2024 Financial Results and Provides Business Update (GlobeNewswire) - "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; (ii) Caribou plans to initiate a pivotal Phase 3 clinical trial in H2 2025 should data confirm the initial observation that partial HLA matching is associated with improved outcomes for patients."

New P3 trial • P1 data • Non-Hodgkin’s Lymphoma

Caribou Biosciences to Present Preclinical Data Supporting Development of CB-010 for Lupus at the American College of Rheumatology Convergence 2024 (GlobeNewswire) - "Caribou Biosciences, Inc...announced an abstract has been accepted for a poster presentation at the American College of Rheumatology (ACR) Convergence 2024, which will be held November 14-19, 2024 in Washington, DC. The poster will highlight the preclinical data and key elements of the clinical trial design that supported the investigational new drug (IND) clearance to evaluate CB-010 in the GALLOP Phase 1 clinical trial in patients with lupus nephritis (LN) and extrarenal lupus (ERL)."

Clinical protocol • Preclinical • Lupus • Lupus Nephritis • Systemic Lupus Erythematosus

Caribou Biosciences Announces the FDA has Granted Fast Track Designations... (GlobeNewswire) - "Caribou Biosciences...today announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designations to CB-010 for refractory systemic lupus erythematosus (SLE)....CB-010, an allogeneic anti-CD19 CAR-T cell therapy, will be evaluated in the GALLOP Phase 1 clinical trial in patients with lupus nephritis (LN) and extrarenal lupus (ERL), subcategories of SLE. The GALLOP clinical trial is on track to initiate by year-end 2024."

Fast track • New P1 trial • Lupus • Systemic Lupus Erythematosus

Caribou Biosciences Reports Second Quarter 2024 Financial Results and Provides Business Update (Caribou Bio Press Release) - "CB-010: Caribou also is enrolling a cohort of up to 10 patients who have relapsed following any prior CD19-targeted therapy in a proof-of-concept cohort in this population of unmet need. This cohort will also incorporate partial HLA matching between donors and patients; Caribou plans to initiate a pivotal Phase 3 trial in the second half of 2025, should data confirm improved outcomes for patients receiving a partially HLA matched dose of CB-010 and following agreement with the FDA on a pivotal trial design."

New P3 trial • Trial status • Hematological Malignancies • 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

A CRISPR-EDITED ALLOGENEIC ANTI-CD19 CAR-T CELL THERAPY WITH A PD-1 KNOCKOUT (CB-010) FOR RELAPSED/REFRACTORY B CELL NON-HODGKIN LYMPHOMA (R/R B-NHL): UPDATED PHASE 1 RESULTS FROM THE ANTLER TRIAL (EHA 2024) - P1 | "Pts underwent lymphodepletion with sequential cyclophosphamide (60mg/kg/day x 2 days) and fludarabine (25 mg/m2/day x 5 days) followed by a single CB-010 infusion. CB-010 showed a manageable safety profile and promising efficacy for the treatment of pts with r/r B-NHL,including those with aggressive subtypes. The dose escalation phase is complete and enrollment of 2L LBCL ptsin the dose expansion phase is ongoing. Initial dose expansion data at the CB-010 RP2D and translational datawill be presented at the meeting."

CAR T-Cell Therapy • IO biomarker • P1 data • Anemia • Dermatology • Graft versus Host Disease • Hematological Disorders • Hematological Malignancies • Immunology • Infectious Disease • Lymphoma • Marginal Zone Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology • Thrombocytopenia • PD-1

A CRISPR-edited allogeneic anti-CD19 CAR-T cell therapy with a PD-1 knockout (CB-010) in patients with relapsed/refractory B cell non-Hodgkin lymphoma (r/r B-NHL): Updated phase 1 results from the ANTLER trial. (ASCO 2024) - P1 | "Pts received lymphodepletion with sequential cyclophosphamide (60 mg/kg/day x 2 days) and fludarabine (25 mg/m2/day x 5 days) followed by a single CB-010 infusion. CB-010 showed a manageable safety profile and promising efficacy for treatment of pts with r/r B-NHL, including aggressive subtypes. The dose escalation phase is complete. Enrollment of 2L LBCL pts in dose expansion is ongoing."

CAR T-Cell Therapy • Clinical • IO biomarker • P1 data • Anemia • Dermatology • Graft versus Host Disease • Hematological Disorders • Hematological Malignancies • Immunology • Infectious Disease • Lymphoma • Marginal Zone Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology • Thrombocytopenia • PD-1

Caribou Biosciences Presents Encouraging Clinical Data from CB-010 ANTLER Phase 1 Trial in Second-line LBCL Patients at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting (GlobeNewswire) - P1 | N=72 | ANTLER (NCT04637763) | Sponsor: Caribou Biosciences, Inc. | "Caribou Biosciences...presented updated clinical data from the ongoing ANTLER Phase 1 trial...The clinical results are being presented during a poster presentation at the 2024 American Society of Clinical Oncology...No Grade 3 or higher cytokine release syndrome (CRS...was observed...Median PFS of 14.4 months (95% CI: 1.74, not estimable [NE]) was observed in patients treated with CB-010 with ≥4 HLA matches (N=13), compared to 2.8 months (95% CI: 2.10, 3.48) for patients treated with CB-010 with ≤3 HLA matches (N=33)....'We expect to report initial data from both the 2L LBCL and CD19 relapsed cohorts in the first half of 2025 and, upon confirmation of improved outcomes in additional patients receiving a partially HLA matched dose of CB-010, we plan to initiate a pivotal Phase 3 clinical trial in 2L LBCL patients, including patients regardless of HLA patients, in the second half of 2025.'”

Cytokine release syndrome • New P3 trial • P1 data • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Caribou Biosciences to Host KOL Discussion with Webcast from the 2024 ASCO Annual Meeting and Participate in Upcoming Investor Conferences (Caribou Bio Press Release) - "Caribou’s webcast of KOL discussion from 2024 American Society of Clinical Oncology (ASCO) Annual Meeting June 2, 2024, CB-010 ANTLER Phase 1 clinical trial data in r/r B-NHL to be shared in a press release at 6:00 pm CDT followed by a live webcast of a discussion with KOLs and management at 7:00 pm CDT."

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

Caribou Biosciences to Present Initial Dose Expansion Data from CB-010 ANTLER Phase 1 Trial in r/r B-NHL at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting (GlobeNewswire) - "Caribou Biosciences, Inc...announced two abstracts have been accepted for poster presentations at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, which will be held May 31-June 4, 2024 in Chicago, Illinois. The ANTLER poster will provide initial dose expansion data....The AMpLify poster will provide details on the clinical trial design and objectives."

Clinical protocol • P1 data • Acute Myelogenous Leukemia • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Caribou Biosciences Expands Clinical Development of CB-010 with FDA Clearance of IND in Lupus (Caribou Bio Press Release) - "Caribou Biosciences...announced that it received clearance of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) for CB-010, an allogeneic anti-CD19 CAR-T cell therapy with a PD-1 knockout (KO), for the treatment of lupus nephritis (LN) and extrarenal lupus (ERL). The Phase 1, multicenter, open label GALLOP clinical trial of CB-010 in patients with LN and ERL is expected to initiate by year-end 2024."

IND • New P1 trial • Lupus • Lupus Nephritis

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

CRISPR-Edited Allogeneic Anti-CD19 CAR-T Cell Therapy for Relapsed/Refractory B Cell Non-Hodgkin Lymphoma (ANTLER) (clinicaltrials.gov) - P1 | N=72 | Recruiting | Sponsor: Caribou Biosciences, Inc.

CAR T-Cell Therapy • Trial completion date • Trial primary completion date • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology