Juno cancer study halted after patient
deaths, shares slide 30 pct
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[July 08, 2016]
By Deena Beasley
(Reuters) - A Juno Therapeutics Inc trial
of its experimental cancer therapy, known as JCAR015, was put on hold by
U.S. regulators after the deaths last week of two leukemia patients, the
company said on Thursday.
Shares of Juno fell 30 percent to $28.50 in after-hours trading on
the Nasdaq after they closed at $40.82.
A third trial patient died in May, Juno Chief Executive Officer Hans
Bishop said during a conference call. All three patients were in
their 20s, and the deaths were linked to swelling in the brain, the
JCAR015 is a chimeric antigen receptor T-Cell, or CAR-T, therapy,
involving a complicated process of extracting immune system T cells
from an individual patient, altering their DNA to sharpen their
ability to spot and kill cancer cells, and infusing them back into
the same patient.
Seattle-based Juno said the deaths occurred after the chemotherapy
agent fludarabine was added to the trial program. The company said
it has proposed to the U.S. Food and Drug Administration that the
trial be continued using JCAR015 with just cyclophosphamide as a
Patients receiving CAR-T therapies typically receive doses of
chemotherapy beforehand, meant to make the tumor more vulnerable to
the CAR-T cell.
In the results so far of some early-stage clinical trials, CAR-T
therapies eliminated all trace of leukemia and lymphoma in 40
percent to 90 percent of patients who had run out of other options.
But the experimental medicines can cause cytokine release syndrome,
a dangerous buildup of toxic debris from killed tumor cells, and
damage to healthy tissue. The inflammation is typically controlled,
however, with steroids and other treatments.
Juno said the FDA asked that the company submit a revised patient
consent form, investigator brochure, trial protocol, and a copy of
the presentation made to the agency on Wednesday. Juno said it plans
to submit the requested information to the FDA this week.
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CEO Bishop said the company will have more clarity in the next few
weeks on timing of the halted trial. Juno had planned to seek
approval for JCAR015 for adult patients with acute lymphoblastic
leukemia by early 2017. The company is testing other CAR-T cells for
pediatric ALL, non-Hodgkins lymphoma and other cancers.
He said Juno's development of other products, including CAR-T
therapy JCAR017, are not affected by the trial hold.
Other companies developing CAR-T therapies include Kite Pharma Inc,
Bluebird Bio Inc, Celgene Corp and Novartis AG.
(Reporting by Deena Beasley in Los Angeles; Editing by Matthew
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