FDA Lifts Clinical Hold on the Investigational New Drug Application for BEAM-201
“The FDA’s clearance of our IND for BEAM-201 is an exciting moment for Beam and for the field of gene editing, as it represents the first IND clearance for a multiplex-base edited investigational drug,” said John Evans, chief executive officer of Beam. “We believe the future of cell therapy involves high levels of cell engineering, enabled by multiplex base editing technology. Combining four unique edits with high efficiency, BEAM-201 has the potential to make a substantial impact for patients diagnosed with these challenging T-cell cancers, who lack innovative, new treatment options for their disease. We’re pleased that this clearance allows us to bring this novel medicine into human clinical trials, and we look forward to providing updates on next steps for the program in 2023.”
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