BLUE - Bluebird bio says lentiviral vector unlikely caused blood cancer which forced trial pause
Bluebird bio (BLUE) is surging in the premarket with a ~13.1% gain so far after the company announced that the case of AML that earlier forced the company to halt two clinical trials in sickle cell disease was unlikely due to BB305 lentiviral vector (“LVV”).Last month, the company halted Phase 1/2 (HGB-206) and Phase 3 (HGB-210) for LentiGlobin in sickle cell disease (“SCD”) BB305 lentiviral vector after finding a suspected unexpected serious adverse reaction (“SUSAR”) of acute myeloid leukemia (“AML”).At the same, the company decided to temporarily suspend its marketing of ZYNTEGLO as it is also manufactured using the same BB305 lentiviral vector.However, the investigations are ongoing for a second SUSAR of myelodysplastic syndrome ("MDS") in a patient from Group C of HGB-206 to determine if the findings meet the criteria for an MDS classification and, if so, if LentiGlobin for SCD had any role.“we believe these results support lifting the clinical
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Bluebird bio says lentiviral vector unlikely caused blood cancer which forced trial pause