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Last November, the FDA signed offBeam Therapeutics Inc’sBEAM Investigational New Drug (IND) application for Phase 1/2 trial for BEAM-101 gene therapy for sickle cell disease.
In the most recent earnings release, the company said it is still working on enrolling its first patient for the trial, dubbed BEACON-101, by year-end.
The company announced in its Q3 update that it’s pushing back plans to file an IND in 2022 for BEAM-102, another sickle cell gene therapy candidate.
To speed up the development of BEAM-101, Beam noted that it’s working to amend the trial to “streamline and expedite patient enrollment and trial conduct based on the recent regulatory landscape in SCD trials.”
As the company explained, patients enrolled in the trial would first have their stem cells retrieved — the cells will be edited ex vivo to make BEAM-101 — receive pre-treatment conditioning before receiving the cells back in a transplant. Only after the first patient’s cells are engrafted can investigators begin treating the second patient.
Hence, the company wants to give itself more time to work on an improved conditioning regimen with lower toxicity.
In the Q3 report, Beam also offered an update on BEAM-201, its base-edited CAR-T therapy, which was placed on clinical hold. Beam has submitted its response to the FDA and will provide an update on the next steps.
Cash, cash equivalents, and marketable securities were $1.1 billion.
Price Action: BEAM shares are down 10.32% at $38.38 on the last check Monday.
