For the second time this year Juno has seen its midstage CAR-T Rocket trial put on hold, although this time the biotech has limited its test on its own, after two patients suffered cerebral edema earlier this week, with one dead as of last night and another died this morning, it said on a call to investors.
The phase 2 study, which has been voluntarily halted, was assessing JCAR015 in patients with relapsed or refractory B cell acute lymphoblastic leukemia.
This comes after the FDA placed a brief clinical hold on the same Rocket trial of JCAR015 in July after several patient deaths, also due to cerebral edema.
The FDA halt was however swiftly lifted a few days later, but with a modified preconditioning regimen that it said would stop future patient deaths. The biotech was at the time adamant that the chemo med fludarabine used as a preconditioning regimen was the primary culprit in the deaths.
“Juno has notified the Food & Drug Administration of the voluntary hold and is working with the agency and the Data and Safety Monitoring Board to determine next steps," the biotech said in a statement. It said it was “evaluating its options” regarding the JCAR015 program.
“Juno’s trials and plans for its other CD19-directed CAR T cell product candidates, including JCAR017, are not affected,” the company noted.
JCAR015 is Juno’s lead candidate, and the company had been hoping for an FDA approval next year, but this timeline was removed over the summer, with its future now hanging in the balance.
Analysts at Leerink said in a note to clients that while "this is a clear blow for Juno," it believes sentiment remains "positively biased on the CAR-T category in general."
Right now, sentiment is negative as its shares took a battering, down by around 30% early this morning on the news, with fellow CAR-T biotechs Kite and bluebird bio also down 4% and 5% respectively.