Cellectis gets U.S.
go-ahead to test 'off-the-shelf' cell therapy
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[February 07, 2017]
(Reuters) - Cellectis has won U.S.
regulatory approval to run an early clinical trial using its gene edited
cell therapy product UCART123 for blood cancers, boosting the French
biotech firm's ambitions in the hot area of cancer research.
Following approval from the Food and Drug Administration, Phase I
clinical trials will start in the first half of this year, the
company said on Monday.
It marks the first time that U.S. regulators have approved clinical
testing of an allogeneic, or "off-the-shelf", gene-edited CAR T cell
The idea of genetically altering immune cells called T cells so that
they can attack cancers more effectively has attracted interest from
a range of drugmakers.
But while rivals such as Novartis, Juno and Kite have treatments
that use modified T cells extracted from individual patients,
Cellectis products are derived from healthy donors and aim to be
Its first such "off-the-shelf" cell therapy UCART19, which is being
developed with Servier and Pfizer, is now being tested in Phase I
trials in Britain for acute lymphoblastic leukaemia and chronic
It has already rescued two babies treated at London's Great Ormond
Street Hospital from previously incurable cancer.
UCART123, which is still wholly owned by Cellectis, is designed to
help patients with acute myeloid leukaemia and blastic plasmacytoid
dendritic cell neoplasm.
(Reporting by Ben Hirschler; Editing by Ruth Pitchford)
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