Bluebird Bio Temporarily Suspends Sickle Cell Gene Therapy Studies Following Incidences of Blood Cancer

Shares of bluebird bio Inc BLUE were sinking Tuesday morning following an adverse clinical pipeline development.

What Happened: Cambridge, Massachusetts-based Bluebird said it has placed the Phase 1/2 and Phase 3 clinical studies of its LentiGlobin gene therapy in sickle cell disease on a temporary suspension.

The decision followed a report of an incidence of acute myeloid leukemia in a patient who was treated more than five years ago in Group A of the Phase 1/2 study dubbed HGB-206.

Additionally, a second incidence of myelodysplastic syndrome was reported in a patient from Group C of HGB-206 last week, the company said.

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Why It's Important: Bluebird previously communicated a delay in the filing of the biologic license application for the gene therapy candidate in early November alongside its third-quarter results.

The purported delay was due to additional information sought by the FDA regarding the manufacturing process.

What's Next: Bluebird said it is investigating the cause of the patient with AML to determine if there is any relationship to the use of BB305 lentiviral vector in the manufacture of LentiGlobin gene therapy for SCD. The second incidence of MDS is also being investigated, the company said. 

"The safety of every patient who has participated in our studies or is treated with our gene therapies is the utmost priority for us," CEO Nick Leschly said in a statement. 

The company also said it has informed the independent safety review board monitoring the company's studies as well as the FDA and European Medicines Agency, and that it will continue to work with regulatory agencies to complete its investigation.

BLUE Price Action: Bluebird shares were trading down 32.47% to $30.90 at last check. 

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