Beam To Complete Clinical Hold Studies This Year

Beam Therapeutics says it will submit a complete response in the fourth quarter of this year to the FDA 7/29 clinical hold on the company’s BEAM-201 IND application for the treatment of relapsed/refractory T-cell acute lymphoblastic leukemia/T-cell lymphoblastic lymphoma. The company says it filed the IND at the end of June for the specific anti-CD7, multiplex-edited, allogeneic chimeric antigen receptor T cell (CAR-T) development candidate.

In an SEC filing, Beam says the agency’s official clinical hold letter requested (1) additional control data from genomic rearrangement assessments; (2) further analyses of certain off-target editing experiments; (3) additional control data for a cytokine independent growth assay; and (4) an updated investigator brochure that includes information regarding any new nonclinical studies.

Beam says it intends to complete the requested studies in time to submit its response before the end of the year.