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Published: Sun, July 10, 2016
Economy | By Melissa Porter

Juno Therapeutics (JUNO) Stock Will Rise Again, RBC's Yee Tells CNBC

Juno Therapeutics (JUNO) Stock Will Rise Again, RBC's Yee Tells CNBC

One of study's researchers says that more than 300 patients have been treated with similar therapies in the US, without reports of brain swelling. Regulators have said they'll review that information quickly, but it's anyone's guess when such a review could result in a lifting of the clinical hold that's been placed on this trial. "By now, most major pharmaceutical companies have jumped into the auto T-cell arena", according to The Scientist, noting that the fledgling sector has seen a rise in scientific, corporate and investor interest beginning in late 2013. Juno is a biopharmaceutical company founded in 2013. The notice to temporarily halt the biotechnology startup's heavily funded clinical trial came after three patients died during the process.

In response, Juno has suggested to the FDA that the ROCKET trial should continue, using only the cyclophosphamide pre-conditioning with JCAR015. The Juno trial made a decision to add the drug to the chemotherapy sessions. The firm believes that a combination of the genetically engineered T cells with a chemotherapy drug led to the fatal problems.

The promising biotech field of CAR-T cell therapy got dealt a blow this week when the FDA put a stop to a clinical trial applying the treatment to leukemia patients.

Kite Pharma (KITE) stock will also make a comeback from trading lower.

However, the FDA hold "will likely impact" Juno's goal of winning approval for the treatment as early as 2017, he said.

Juno shares closed down 32 percent on Friday, to $27.81.

Juno's treatment, known as JCAR015, was being tested in adults facing their third or fourth bouts with leukemia.

Conducting a similar trial funded by Novartis, Dr. Stephan Grupp, Novotny Professor of Pediatrics at the University of Pennsylvania Perelman School of Medicine, said none of his patients experienced brain swelling even after the addition of fludarabine.

"We are optimistic that we will achieve results comparable to those obtained in the phase 1 trial....and address a significant unmet need in these patients, most of whom have exhausted all other therapies", he said.

The news of the trial's suspension sent Juno's stock down more than 30 percent.

JCAR015 is being studied as a treatment for advanced cases of acute lymphoblastic leukemia, or ALL. As The Scientist notes, "This disease is extremely hard to treat and progresses rapidly when it becomes refractory; most patients die within a few months".

Like Provenge, Juno's CAR-T therapy is complicated, with numerous moving parts - how many cells to remove from patients, how many to return, what companion drugs should be given. "Juno Therapeutics stopped its phase 2 "ROCKET" trial for JCAR015 under instruction from the FDA after the two recent deaths, which follow another earlier this year - though the company hopes to restart the trial after making changes to how the drug is delivered", according to a recent UPI News report.

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