A third trial patient died in May, Juno Chief Executive Officer Hans Bishop said during a conference call.
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Juno Therapeutics said that two patients died during its clinical trial for a cancer therapy and that the U.S. Food and Drug Administration has placed the experiment on hold.
The Phase 2 trial of JCAR015 tested the drug in patients with relapsed or refractory B cell acute lymphoblastic leukemia.
The company had previously anticipated approval by 2017.
The clinical hold on JCAR015 is a damaging blow to Juno and casts a tragic shadow over what has been seen as a promising new immunotherapy.
The company said that the deaths occurred after it added fludarabine, a chemotherapy drug, to its pre-conditioning regimen. In response, the FDA has requested a revised patient informed consent form, a revised investigator brochure, a revised study protocol and a copy of the presentation made to the agency yesterday.
He said Juno’s development of other products, including CAR-T therapy JCAR017, are not affected by the trial hold.
For CAR-T treatment, patient’s immune cells are removed, genetically engineered to better target cancerous cells, and then reinserted into the body to attack the cancer.
Patients receiving CAR-T therapies typically receive doses of chemotherapy beforehand, meant to make the tumor more vulnerable to the CAR-T cell.
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The news sent Juno’s share price down roughly 30 percent after hours on Thursday. But the deaths could also more widely impact the CAR-T space, drawing more scrutiny over the effects of engineering human immune cells.
