Juno Therapeutics halts study after more patient deaths; shares crash

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Juno Therapeutics Inc.’s (Seattle WA) shares plunged 23% last week after the biopharmaceutical company voluntarily placed a mid-stage clinical trial on hold after two patients suffered cerebral edema earlier in the week.

@JunoThera shares plunge on news company suspended clinical trial of #leukemia drug Click To Tweet

Both patients died, which brings the study’s death toll to five, according to CNBC. JCAR015 is intended to be used to treat patients with relapsed or refractory acute lymphoblastic leukemia. Patients who have a relapse of this cancer often have few or no other options.

“Of the 12 patients treated following protocol update, without fludarabine, 10 patients had high disease burden,” said Peter Lawson, a SunTrust Robinson Humphrey analyst, in a research note. “One of the recent patients with cerebral edema had high disease burden, the other patient did not, indicating disease burden might not be contributing to the higher proliferation of JCAR015 and subsequent neurotoxicity.”

The JCAR015 drug was designed to fight cancer by using patients’ own immune systems against the disease. However, the drug prototype has been plagued by issues in testing. Three additional patients died in July from side effects while enrolled in studies of the same drug.

“There is hope,” Citi analyst Robyn Karnauskas told CNBC: “This company has a lifesaving drug with high cure rates and is treating patients with a short life span.” She added, “This is just a short setback. The company is trying to figure out how to develop this drug in the safest way possible.”

Juno has contacted the Food and Drug Administration and is collaborating with the Data and Safety Monitoring Board to determine how to move forward. If the FDA gives Juno approval to resume the trials, the company can either modify the study, start a new one or terminate the program, Karnauskas said.

“We’re going to have to wait for a week or two at least to figure out what the real option or the real path forward for this company is,” Karnauskas said. “We think most likely they’ll develop this drug and even if they don’t, they have other drugs in their pipeline.”

Juno closed the week down 23% at $23.01.

Steve’s Take:

Yes, leukemia is a horrific illness everyone wants to see beaten. But a time may come to throw in the towel with a particular experimental treatment. Or perhaps not.

Juno’s leukemia study had already been linked to three patient deaths back in July, but company executives pinned the blame on chemotherapy drugs used in a pre-treatment drug cycle, says Zacks. The latest deaths, which occurred last week, come a result of severe brain swelling, which was the same symptom seen in the earlier deaths.

For now, the new therapy, JCAR015, will be put on hold. Juno announced that it voluntarily put the study on pause and informed the Food and Drug Administration about that decision several days ago. CEO Hans Bishop said that the company is still investigating the deaths and has not yet decided whether it will continue developing the treatment.

JCAR015 is a new type of chimeric antigen receptor T-Cell (CAR-T) therapy. The treatment includes the extraction of T-cells from a patient, which then undergo DNA modifications before being infused back into the individual. The altering of the DNA is meant to improve the T-cells’ ability to identify and fight cancer cells.

While CAR-T treatments have proven to be impressively effective in eliminating certain types of blood cancers, the patient deaths in Juno’s study are a major setback for the experimental drug.

A decision point has now arrived, one that is perhaps the hardest of all to make by a company like Juno, so determined to finding a treatment for leukemia, where others have failed. Not an easy, clear-cut decision, I’m fairly certain. And not for the fainthearted.

But trepidation and/or indecision is not in the fabric of Hans E. Bishop, Juno’s president, CEO and co-founder. He’ll make the correct decision, taking all the “larger” issues into account. Sleep well, Juno shareholders.

Steve's Take: @HansBishop1 will make correct decision. Sleep well, @JunoThera shareholders Click To Tweet

Disclaimer: All posts are purely my opinion. I am not a financial advisor, so please conduct your own due diligence on any and all stocks mentioned.

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