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Article source: Medical Rubik's Cube Info
Author: Qingwa
Bluebird announced its 2021Q2 financial report on August 10, in which it mentioned that the FDA has suspended its gene therapy elivaldogene autotemcel (eli-cel, Lenti-D™) for phase III adrenal leukodystrophy (CALD) Clinical trials
The suspension of clinical trials caused investors to sell off.
The financial report mentioned that a suspected unexpected serious adverse reaction (SUSAR) report of myelodysplastic syndrome (MDS) showed that it may be caused by the insertion of Lenti-D lentiviral vector (LVV)
On July 21 this year, the European Commission has approved its one-time gene therapy Skysona (elivaldogene autotemcel, Lenti-D) for the treatment of sibling hematopoietic stem cell (HSC) donors under the age of 18 who carry the ABCD1 gene mutation and have no HLA matching Available in patients with early cerebral adrenal leukodystrophy (CALD)
Bluebird said that clinical shelving will not affect its sickle cell disease (SCD), β-thalassemia and oncology projects
In January 2021, bluebird announced its intention to split into two independent listed companies (bluebird bio and 2seventy bio), and the company expects that the split will be completed by the end of 2021
