The death of the very first patient treated has forced Cellectis (Nasdaq: CLLS) to stop running its two Phase I trials of a gene edited ‘off-the-shelf’ immunotherapy, sending the France-based company’s share price plummeting by more than 20% on Tuesday.
The company’s sole focus is on developing immunotherapies based on gene-edited allogeneic CAR T-cells, which it refers to as UCARTs, and UCART123 is its first wholly-owned product candidate.
It was being tested in both acute myeloid leukemia (AML) and in blastic plasmacytoid dendritic cell neoplasm (BPDCN) but Cellectis has announced that the US Food and Drug Administration (FDA) has placed a clinical hold on both studies.
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