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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
-- CaMMouflage Phase 1 clinical trial to initiate patient enrollment at dose level 1 in early 2023 -- -- CB-011 is engineered with a differentiated immune
About this update from Caribou Biosciences, Inc.
[{"type":"text","content":"-- CaMMouflage Phase 1 clinical trial to initiate patient enrollment at dose level 1 in early 2023 -- -- CB-011 is engineered with a differentiated immune cloaking strategy, designed to enhance persistence -- -- CB-011 is Caribou’s second off-the-shelf CAR-T cell therapy to enter the clinic -- BERKELEY, Calif., Nov. 21, 2022 (GLOBE NEWSWIRE) -- Caribou Biosciences, Inc. (Nasdaq: CRBU), a leading clinical-stage CRISPR genome-editing biopharmaceutical company, 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, a genome-edited allogeneic anti-BCMA CAR-T cell therapy with immune cloaking. 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. “Clearance of our second IND application represents another key milestone for our pipeline of promising allogeneic cell therapies designed to have enhanced persistence of antitumor activity,” said Rachel Haurwitz, Ph.D., Caribou’s president and chief executive officer. “CB-011 is designed with an immune cloaking strategy to reduce rejection of the cell therapy by a patient’s T and NK cells and we use Caribou’s highly precise and specific Cas12a chRDNA genome-editing technology to manufacture this product candidate. We are excited to develop CB-011 as an off-the-shelf cell therapy that may reach a broader number of patients with multiple myeloma than are currently being served, and we look forward to initiating patient enrollment in the CaMMouflage trial in early 2023.” CB-011 is the second allogeneic cell therapy advancing into clinical development from Caribou’s CAR-T cell platform targeting hematologic malignancies. Caribou’s first allogeneic cell therapy, CB-010, an allogeneic anti-CD19 CAR-T cell therapy with a PD-1 knockout, is being evaluated in the ongoing ANTLER Phase 1 clinical trial in patients with relapsed or refractory B cell non-Hodgkin lymphoma (r/r B-NHL). Encouraging safety and antitumor activity for CB-010 at dose level 1 have been reported from the ANTLER trial. “CAR-T cell therapies have shown great promise for t...