Caribou Biosciences Gets FDA Clearance for CB-011 IND Application

By Chris Wack

Caribou Biosciences Inc. said Monday that it has received U.S. Food and Drug Administration clearance of its investigational new drug application for CB-011, a genome-edited allogeneic anti-BCMA CAR-T cell therapy with immune cloaking.

The company said the Phase 1 clinical trial, an 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, is expected to initiate patient enrollment for treatment at dose level 1 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 Biosciences shares were up 5% to $9.55 in premarket trading.

Write to Chris Wack at chris.wack@wsj.com

(END) Dow Jones Newswires

November 21, 2022 09:35 ET (14:35 GMT)

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