junologo

US FDA lifts hold on Juno’s CAR-T therapy trials; shares jump

pharmafile | July 13, 2016 | News story | Research and Development, Sales and Marketing Stock Price, US FDA, drug trial, juno therapeutics 

Shares in Juno Therapeutics (Nasdaq: JUNO) jumped to close up almost 30% after the company said the US Food and Drug Administration (FDA) has lifted the hold on mid-stage trials for chimeric antigen receptor T cell (CAR-T) therapy to potentially treat blood cancer.

Last week the regulators placed on hold the trials for refractory B cell acute lymphoblastic leukaemia following the deaths of two patients from cerebral oedema.

The deaths followed the recent addition of chemotherapy drug, Fludarabine, to the pre-conditioning program, according to Juno.

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As part of the clinical hold, the FDA directed Juno to submit a complete response requiring the company to revise several documents including its informed consent form and trial protocol.

Juno said under the new protocol, enrolment in the trial will continue using the trial compound, JCAR015, with cyclophosphamide pre-conditioning only.

The biotech firm entered a 10-year agreement last year with Celgene (Nasdaq: CELG) to develop treatments for cancer and autoimmune diseases that initially focused on CAR-T therapies.

Anjali Shukla

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