The Food & Drug Administration, a US health authority, has lifted the notice of suspension of clinical trials for biotech, which had plunged Cellectis into the stock market in October.
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The way is clear for Allogene, partner of Cellectis, in the United States | Photo credits: trangêne
Green light for Allogene, a licensed partner of Cellectis, in the United States. The health authority, the Food & Drug Administration (FDA), has lifted the notice of suspension of clinical trials for biotech, which now plans to continue its work and initiate a phase 2 study for its lymphoma treatment. large B cells.
On October 7, the FDA suspended the five Allogene clinical trials following the report of a chromosomal abnormality detected in the CAR + T ALLO-501A cells of a single patient included in the ALPHA2 clinical trial promoted by Allogene . This caused the Cellectis share to fall sharply during the Friday October 8 session, by more than 20%.
Specifically, the FDA had suspended, for analysis, all clinical trials of Allogene Therapeutics using allogeneic CAR-T. This immunotherapy technology (T cells with chimeric antigen receptor – CAR) in oncology consists in genetically reprogramming T lymphocytes, in order to allow them to specifically recognize the signals expressed by cancer cells in order to kill them. The T cells are taken from the patient, modified in the laboratory, and then reinjected.
Phase 2 trial in mid-2022
Allogene announces that research has established that the chromosomal abnormality is unrelated to TALEN® genome editing technology or the Allogene manufacturing process, and has no clinical significance. The abnormality was not detected in any AlloCAR T product manufactured, nor in any other patient treated with the same lot of ALLO-501A. The abnormality manifested itself in the patient after administration of the candidate product. It involved regions of the T cell receptor and immunoglobulin genes known to experience rearrangements as part of the natural process of T or B cell maturation.
The American biotech therefore plans to initiate a pivotal phase 2 trial of the candidate product ALLO-501A in the treatment of relapsed or refractory large B-cell lymphoma, in mid-2022 in the United States. Diffuse large B-cell lymphoma is the most common lymphoma. This cancer develops at the expense of B lymphocytes, which make antibodies in our immune system.
The Cellectis share recovers by 7% at the start of the morning on Tuesday, to 7.40 euros.