Caribou Biosciences 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. CB-011 is being evaluated in the company’s ongoing CaMMouflage Phase 1 clinical trial in patients with r/r MM. "Fast Track designation for CB-011 allows us instrumental interactions with the FDA as we progress our clinical development and regulatory plans for CB-011. This designation could not be more timely as we recently dosed our first patient in the CaMMouflage Phase 1 trial," said Syed Rizvi, MD, Caribou’s chief medical officer. "Our goal is to develop CB-011 as a readily available off-the-shelf treatment option for patients with relapsed or refractory multiple myeloma to overcome the need for apheresis or bridging therapy, variable quality and long manufacturing timelines, manufacturing failures, or the inability to bear the burden of treatments that require frequent dosing over several months."
Published first on TheFly
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