Juno Therapeutics, the Seattle-based biotech company developing immunotherapy treatments for cancer, announced it has placed a voluntary hold on the clinical trial of its JCAR015 cancer treatment, following two patient deaths this week.
In a conference call with analysts Wednesday morning, Juno CEO Hans Bishop said that “all options remain on the table” for the clinical research, including a modified program or an entirely new study. Bishop also said they may consider “terminating the program.”
“We are faced with a difficult decision, considering the encouraging early efficacy data in this trial and the poor prognosis of these relapse refractory (acute lymphoblastic leukemia) patients, who have few, if any treatment options,” Bishop said in the call.
Juno’s stock plunged as far as 44 percent before market opening today, and it is now down 26 percent, trading at $21.94.
JCAR015 is one of several immunotherapy drugs in Juno’s pipeline, which uses the body’s immune system to fight cancer. This is the second hold that has been placed on the trial this year. In July, the U.S. Food and Drug Administration placed a hold on a Juno Therapeutics‘ clinical trial of the leukemia treatment following the death of two trial patients from cerebral edema, or brain swelling.
The swelling was thought to be caused by the interaction of two drugs, and the trial resumed after one was removed. However, the recent patient deaths were also due to cerebral edema, indicating there may be another issue.
Juno initially said that JCAR015 would be approved by the FDA by early next year, but the two stumbles in the trial provides doubt about the future of the program.
Juno and others’ research on immunotherapy could have a huge impact on how cancer is treated, and potentially yield treatments or cures for patients that have little hope of recovery.
Bishop assured analysts in the call that the hold on JCAR015 would not affect the development of other drugs in the company’s pipeline, including JCAR014, which showed promise in treating lymphoma patients in an early-stage trial in September.