In March 2021, LLS made an equity investment in Caribou Biosciences and is currently supporting "A Phase 1 Study of CB-010, a CRISPR-Edited Allogeneic Anti-CD19 CAR-T Cell Therapy, in Patients With Relapsed/Refractory B Cell Non-Hodgkin Lymphoma (ANTLER) and A Phase 1 Study of CB-011, a CRISPR-Edited Allogeneic Anti-BCMA CAR-T Cell Therapy, in Patients With Relapsed/Refractory Multiple Myeloma (CaMMouflage)."
Caribou is a leading clinical-stage biotechnology company, co-founded by CRISPR pioneer and Nobel Prize winner Jennifer Doudna, Ph.D., using next-generation CRISPR genome-editing technology to develop “off-the-shelf” (allogeneic) CAR therapies for hard-to-treat blood cancers. Off-the-shelf therapies use donor cells instead of reengineering a patient’s own cells. This approach could make treatment less costly and immediately available to patients with rapidly progressing disease.
CRISPR genome editing uses easily designed, modular biological tools to make DNA changes in living cells. CRISPR systems occasionally edit unintended genomic sites, known as off-target editing, which may lead to harmful effects on cellular function. In response to this challenge, Caribou has developed chRDNAs (pronounced “chardonnays”) that direct substantially more precise genome editing to provide substantial advantages in genome editing specificity and efficiency to enhance persistence and drive clinical durability in multiple malignancies.
CB-010, Caribou’s lead allogeneic CAR-T cell program, targets CD19 and is being evaluated in a Phase 1 clinical trial expansion cohort for second-line patients with large B cell lymphoma (LBCL). (NCT04637763). It is the first clinical-stage allogeneic CAR-T cell therapy in which PD-1 was genetically disrupted in the CAR-T genome, leading to more durable anti-tumor activity in pre-clinical studies.
CB-011, Caribou’s second allogeneic CAR-T cell therapy, targets BCMA for the treatment of relapsed/refractory multiple myeloma and is immunologically cloaked for enhanced persistence. 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 currently enrolling (NCT05722418).
CB-012, Caribou’s third allogeneic CAR-T cell therapy, targets CLL1 for the treatment of relapsed/refractory acute myeloid leukemia. CB-012 is engineered with five genome edits and is the first allogeneic CAR-T cell therapy with both checkpoint disruption through a PD-1 knockout and immune cloaking. The IND has been cleared by the FDA and the AMpLify Phase 1 clinical trial for patients with relapsed or refractory acute myeloid leukemia is expected to begin in mid-2024.
For more information about Caribou, visit www.cariboubio.com.
- October 18, 2023 - announced clearance of its IND application from the FDA for CB-012, an allogeneic anti-CLL-1 CAR-T cell therapy, being developed for patients with relapsed or refractory acute myeloid leukemia (r/r AML).
- July 13, 2023 - announced positive clinical data from dose escalation of CB-010 ANTLER Phase 1 trial in r/r B-NHL
- July 6, 2023 - announced $25M equity investment by Pfizer to advance clinical development of CB-011
- April 16, 2023 - presented preclinical data of CB-012, a next-generation CRISPR-edited allogeneic anti-CLL-1 CAR-T cell therapy, at AACR Annual Meeting
- April 4, 2023 - announced that the FDA has granted Fast Track designation to CB-011, which is being developed for relapsed or refractory multiple myeloma (r/r MM)
- March 29, 2023 - announced initiation of the dose expansion portion of the CB-010 ANTLER Phase 1 trial in second-line patients with large B cell lymphoma (LBCL) following the recent completion of dose escalation.
- December 12, 2022 - reported new 12-month clinical data from cohort 1 in the ongoing ANTLER Phase 1 trial, which show long-term durability following a single infusion of CB-010 at the initial dose level. Based on promising initial data, the U.S. Food and Drug Administration (FDA) granted CB-010 both Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations.
- November 21, 2022 - announced that it has received clearance of its IND application from the FDA for CB-011, a genome-edited allogeneic anti-BCMA CAR-T cell therapy with immune cloaking.
- May 12, 2022 - announced initial results demonstrating a 100% overall response rate (ORR) and 80% complete response rate (CR) in cohort 1 (n=5 evaluable) from its ANTLER Phase 1 trial for CB-010 in patients with relapsed or refractory B cell non-Hodgkin lymphoma (r/r B-NHL).