FDA puts clinical hold on Beam Theraputics’ cancer therapy

AML leukaemia leukemia

Beam Therapeutics Inc., a U.S. biotech company developing precision genetic medicines through base editing, says the company was informed via email last week that the U.S. Food and Drug Administration (FDA) has placed a hold on the BEAM-201 Investigational New Drug (IND) application for the treatment of relapsed/refractory T-cell acute lymphoblastic leukemia (T-ALL)/T cell lymphoblastic lymphoma (T-LL). 

BEAM-201 is a potent and specific anti-CD7, multiplex-edited, allogeneic chimeric antigen receptor T cell (CAR-T) development candidate. The BEAM-201 IND was submitted at the end of June. 

The FDA indicated it will provide an official clinical hold letter to Beam within 30 days. Beam plans to provide additional updates pending discussion with the FDA. The company did not reveal the reasoning behind the FDA’s decision.

Sickle cell work

In May, Beam said it would be funding and collaborating with the National Alliance of Sickle Cell Centers (NASCC) to initiate the AUNT (Achieving Understanding of the Natural History of Sickle Trait) study, a natural history study of sickle cell trait.

The same month, the company published its Q1 financial results, which revealed a net loss of $69.2 million for the first quarter of 2022.

About Beam Therapeutics

Beam Therapeutics is a biotechnology company committed to establishing a fully-integrated platform for precision genetic medicines. To achieve this, Beam has assembled a platform that includes a suite of gene editing and delivery technologies and is in the process of building internal manufacturing capabilities. 

Beam’s suite of gene editing technologies is anchored by base editing, a technology designed to enable precise, predictable and efficient single base changes, at targeted genomic sequences, without making double-stranded breaks in the DNA. 

The company said this has the potential to enable a wide range of potential therapeutic editing strategies that Beam is using to advance a diversified portfolio of base editing programs. 

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