Drug Development

Controversial patient deaths in CAR-T study spur a class action suit against Juno

Juno continues to feel the fallout from its painful, and very brief, trial hold for its lead CAR-T JCAR015. In a newly filed class action suit, investors say that they were purposefully misled by Juno executives, who kept quiet about the first suspicious patient death in May.

Juno CEO Hans Bishop

Juno CEO Hans Bishop

According to the suit, the company was prompted to tell regulators about the death due to a cerebral edema. But when it came to its June earnings announcement, the company stayed silent about any deaths, sticking to evidence of grade 3 neurotoxicity. And with the company touting its results, CEO Hans Bishop cashed out of $8.6 million in shares.

There’s nothing unusual about class action lawsuits in the wake of clinical setbacks. A roster of firms makes a business out of routinely targeting biotechs that have had to concede trial failures. And only occasionally have the feds come back to charge execs with purposefully misleading investors.

Still, this latest suit raises fresh questions about the timeline of deaths and Juno’s interactions with the FDA on its leading clinical study. At the same time Juno announced that a string of deaths had spurred the agency to drop a hold on the study, Bishop and others had already fingered the addition of fludarabine as the prime cause of the lethal neurotoxicity. And regulators were willing to lift the hold just a few days later, even as questions continued to surface about the cause.

Juno continues to suffer the consequences, though. As we reported, the setback forced Juno to revise its timeline for an expected approval, shoving back any formal marketing decision to 2018. And that leaves Kite in command of the lead with a rival CAR-T that the biotech plans to hustle to the FDA before the end of this year.

Soon after the hold was lifted at Juno, I asked the FDA a few questions about the timing and circumstances around the speed of its response. Citing privacy policies, the agency declined to answer.

It may have to provide answers to the lawyers, though, if the suit goes anywhere.

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