Allogene Therapeutics Drops Premarket After FDA Puts Hold on Study
October 08 2021 - 7:20AM
Dow Jones News
By Chris Wack
Allogene Therapeutics Inc. shares fell 38% to $15 in premarket
trading after the company said the U.S. Food and Drug
Administration put a hold on AlloCAR T clinical trials following a
report of a chromosomal abnormality in a patient.
The biotechnology company said it expects to provide additional
updates following consultation with the FDA, which is continuing to
review the end of Phase 1 materials submitted in anticipation of an
ALLO-501A phase 2 trial.
The clinical hold follows the company's notification to the FDA
of a chromosomal abnormality in an ALPHA2 study patient, which was
detected in a bone marrow biopsy undertaken to assess
pancytopenia.
The single case involves a patient with Stage IV transformed
follicular lymphoma and c-myc rearrangement whose cancer was
refractory to two prior lines of immune-chemotherapy and additional
radiation therapy. The patient couldn't receive an autologous CD19
CAR T cell therapy due to manufacturing failure associated with
inadequate expansion of autologous CAR T cells. The patient
subsequently developed progressive pancytopenia and a bone marrow
biopsy showed aplastic anemia and the presence of ALLO-501A CAR T
cells with the chromosomal abnormality.
Allogene has dosed more than 100 patients with its gene edited
AlloCAR T products. The company said it believes the data generated
from the trials support a favorable clinical profile for ALLO-501A
in patients with large B cell lymphoma.
Write to Chris Wack at chris.wack@wsj.com
(END) Dow Jones Newswires
October 08, 2021 07:05 ET (11:05 GMT)
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