But when two more deaths occurred as a result of cerebral oedema last week, the trial was put on hold by the Food and Drug Administration (FDA), until Juno can prove that it’s safe to continue. The FDA will coordinate with Juno Therapeutics for the timing of the trial.
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The patients were enrolled in a trial testing a therapy called JCAR015, which is aimed at treating relapsed or refractory B-cell acute lymphoblastic leukemia in adults.
Three patients died after excess fluids accumulated in their brains, Juno said.
The broker said it has now set a “Outperform” rating on shares of Juno Therapeutics Inc with a price target of 61.
Juno Therapeutics, Inc.is a biopharmaceutical company.
Shares of Juno fell 30 percent to $28.50 in after-hours trading on the Nasdaq after they closed at $40.82. The Company is developing cell-based cancer immunotherapies based on its chimeric antigen receptor (CAR) and T cell receptor (TCR) technologies to genetically engineer T cells to recognize and kill cancer cells. This gives the engineered cancer-killing cells a better chance of growing in the body.
The two deaths happened after Juno added fludarabine, a chemotherapy drug, to the treatment patients received before going through the gene engineering process.
In early stage clinical trials, CART therapies were found to eliminate all trace of lymphoma and leukemia in 40 percent to 90 percent of participants.
However, the experimental medicines can cause several side effects, including cytokine release syndrome and damage to healthy tissue. The inflammation is typically controlled, however, with steroids and other treatments. “No doubt it is hard for the physicians who are looking after these patients and their families”. Clearly these therapies are potent, that’s why they offer the potential for cures.
“We’d be more comfortable if the mechanism behind the neurotoxicity was better understood”.
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Juno Therapeutics plans to submit a revised patient consent form, trial protocol, investigator brochure and a copy of the presentation to the FDA this week. But adding fludarabine in other immunotherapy trials improved outcomes with no additional risks, Bishop said, so the company made a decision to try it with JCAR015.
