They killed three patients back in July, which led to an FDA halt of their program, only to be lifted and then result in the deaths of another two. While some might argue the patients were going to die anyway, as lymphoblastic leukemia isn’t exactly the common cold, running trials on people that consistently result in their deaths isn’t exactly progress either.
Adam Feuerstein, biotech writer at TheStreet.com, weighs in.
To folks defending $JUNO b/c CAR-T eligible cancer patients were going to die, anyway. Perhaps, but you can’t HASTEN THEIR DEATHS!
— Adam Feuerstein (@adamfeuerstein) November 23, 2016
Seems highly likely, necessary, for FDA to shut down $JUNO entirely, all CAR-T programs, until they figure out what is going wrong.
— Adam Feuerstein (@adamfeuerstein) November 23, 2016
Source: Bloomberg
The patients were part of Juno’s mid-stage “Rocket” trial to treat acute lymphoblastic leukemia, and developed cerebral edemas this week, the company said Wednesday in a statement and during a conference call. The trial is testing the drugmaker’s lead product, called JCAR015.Acute lymphoblastic leukemia, or ALL, is an aggressive blood cancer that progresses quickly without treatment. It is the most common type of cancer in children, who are often cured, according to the National Cancer Institute. Juno was testing its therapy in patients whose cancer had come back after other treatments.
“These are obviously difficult times for us,” Chief Executive Officer Hans Bishop said on the call with investors. “Adult ALL is proving to be a difficult disease, but we really are not ready to give up on it.”
Juno’s trial has a rocky history: It was halted in July after three patients died, and then a week later was allowed to resume by U.S. regulators. Since then, 12 patients have been treated, including the two who have died. Juno’s approach involves removing a patient’s immune cells, genetically engineering them to recognize cancer cells, and reinfusing them back into the body.
Juno said it has told the Food and Drug Administration about the hold and is weighing its options. That may include testing the drug further in the disease, according to Mark Gilbert, the company’s chief medical officer.
“It’s important to say that we see a likely path forward for JCAR015 in ALL,” Gilbert said, though “it’s still too early” to be sure what it would look like.
After the trial halt in July, Juno pointed to fludarabine, a drug being given as part of the therapy, as a potential cause of the brain swelling. Cutting out fludarabine helped but wasn’t sufficient, Bishop said on the call.
“It undoubtedly contributed in the way we expected, it just hasn’t gotten us as far as we hoped it would,” he said
As you could imagine, the stock is in free fall mode.
Since its peak, JUNO has shed more than $6b in market cap. Interestingly, other Car-t plays, KITE, BLCM, BLUE, aren’t doing to badly today, all things considered. As a matter of fact, BLUE is higher on the day.
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