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Cellectis floored by patient death in CAR-T trial

FDA puts two cancer immunotherapy trials on hold

Cellectis logoTwo trials of Cellectis' off-the-shelf CAR-T candidate have been put on hold by the FDA after the first patient to receive the cancer immunotherapy died.

The 78-year-old man with blastic plasmacytoid dendritic cell neoplasm (BPDCN) started the treatment with Cellectis' UCART123 candidate at the MD Anderson Cancer Centre in the US in mid-August but succumbed to severe toxicity eight days after receiving an infusion with the cancer-targeting white blood cells.

The patient developed cytokine release syndrome - a recognised side effect with CAR-T therapies - as well as grade 4 capillary leak syndrome, according to the Paris-based biotech. He died despite treatment with corticosteroids and Roche's Actemra (tocilizumab), which was approved by the FDA to treat CRS just days ago.

Shares in Cellectis went into a nosedive on news of the clinical hold, which affects its phase I trial of the CD123-targeting therapy in BPDCN and a second study in acute myeloid leukaemia (AML). The first patient to be treated in the AML trial - a 58-year-old woman - also developed CRS and capillary leak syndrome but was managed with drug therapy and symptoms had resolved 12 days after the procedure.

Neither of the patients developed graft-versus-host-disease (GVHD), a scenario in which the infused cells mount an immune reaction against the recipient. That is an important issue for Cellectis, as it is trying to develop 'allogeneic' CAR-T which does not require cells to be harvested from patients, unlike 'autologous' therapies developed by the likes of Novartis and Kite Pharma.

What happens next for Cellectis is hard to gauge. Another CAR-T developer - Juno Therapeutics - had its lead therapy JCAR015 placed under a clinical hold by the FDA after a patient death last year and while it got a green light to restart testing, subsequent patient deaths prompted another clinical hold and ultimately a decision to halt the programme. It may be that the FDA will exercise greater caution in Cellectis' case.

The French biotech has another CAR-T therapy in clinical testing - CD19-targeting UCART19 for acute lymphoblastic leukaemia (ALL) - and this is unaffected by the clinical hold, with trials ongoing in the UK with approval for a US study granted by the FDA. UCART19 is partnered with Servier and Pfizer.

Cellectis' Nasdaq-listed shares are currently trading at around $25, down from more than $32 ahead of the patient death announcement.

Article by
Phil Taylor

6th September 2017

From: Research

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