Wednesday, 22 November, 2017

Juno halts midstage drug study over deaths

Hans Bishop CEO of Juno Therapeutics Hans Bishop CEO of Juno Therapeutics
Sammy Stanley | 12 July, 2016, 06:35

Link: Shareholder Alert: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Juno Therapeutics Inc.

The news of the trial's suspension sent Juno's stock down more than 30 percent. Juno Therapeutics, which is based in Seattle, reported it to the Food and Drug Administration. That's done by genetically modifying a patient's immune T cells to attack the cancer. But the method can produce severe side-effects, including immune system overreactions and neurological toxicity - like the brain-swelling that proved fatal in this trial. A number of other companies, including Kite Pharma and Novartis, are also developing CAR-T treatments.

While the company is still investigating these deaths, the culprit seems to be a chemotherapy drug called fludarabine. Juno CEO Hans Bishop said his company and the FDA agreed that a "change at the time was not warranted", because they did not believe the death was related to the treatment. All three of these patients were also on a pre-conditioning regimen of fludarabine. The notice to temporarily halt the biotechnology startup's heavily funded clinical trial came after three patients died during the process. Specifically, it suggests a combination of a current standard of care chemotherapy drug called fludarabine and the company's experimental CART candidate JCAR015 is the root of the edemas. "It's unfortunate, but I don't know how you avoid it", Dr Otis Brawley, chief medical officer for the American Cancer Society, told AP. In response to the hold, Juno plans to omit fludarabine from the trial, which is known as ROCKET, and will provide a complete response to the FDA this week. One investor said it's risky to change an experimental protocol like that and questioned whether the move, meant to improve the efficacy of the manipulated T cells, was too aggressive. Before allowing the company to do so, the FDA asked that Juno submit a raft of revised materials, including patient consent forms, investigator brochures, and the trial protocol. Juno has been studying many similar gene-altering immunotherapies for different types of leukemia and expects its first approval in early 2018. While Juno may be successful in this effort, the bigger issue is that Kite and Juno's lead therapies are probably going to be relegated to the status of later lines of treatment, in the best-case scenario, due to these lingering safety concerns.

Juno stock had actually closed Thursday's trading at $40.82, rising more than two percent. Investors were apparently concerned that Juno's problems could portend more regulatory scrutiny or other difficulties for the entire field.

A Juno Therapeutics Inc trial of its experimental cancer therapy, known as JCAR015, was put on hold by US regulators after the deaths last week of two leukemia patients, the company said on Thursday. As these super-charged T-cells reproduce and spread throughout the body, they identify, bind to, and destroy the cancerous cells.

US biotechnology company Juno Therapeutics Inc (NASDAQ:JUNO) collapsed on Wall Street after announcing that two patients undergoing clinical trials of its experimental treatment against leukemia have died.

Two leukemia patients involved in the trial died last week, while a third passed away in May.

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