Juno shares dive as clinical test halted after 2 deaths

Juno will to comply with the request this week, the company said. For those not familiar with CART type therapy, it’s a new generation of cancer treatments that aims to stimulate a patient’s immune system into targeting and attacking cancerous cells.

The three patients who died had something in common besides age and illness: they were each given the chemotherapy drug fludarabine prior to receiving the new treatment. Consequently, Kite’s CAR-T product candidate, KTE-C19, indicated for aggressive non-Hodgkin lymphoma, now appears to be in the catbird seat in terms of being the first to market.

Juno executives were hoping to get FDA approval as early as 2018, yet the hold on the trial sessions could mean a setback on the treatment and questioning from the general public.

A problem with targeting CD19 would really spell trouble for the whole CAR-T field, as it’s the most popular strategy.

Moreover, Juno’s managers said the company has a good idea of why some of the study patients died.

Juno said it has proposed to the FDA to continue the JCAR015 trial by using another chemo agent, cyclophosphamide, and discontinuing use of fludarabine. All three patients were in their 20s, and the deaths were linked to swelling in the brain, the company said.

The trial has been put on hold following the news, which is devastating for the families involved, but also a blow for scientists working on T-cell therapy – heralded as one of the most promising new treatments in cancer research.

Juno’s trial, called ROCKET, was seeking to erase cancers from the bodies of adults with acute lymphoblastic leukemia.

A study of an experimental treatment for leukemia was abruptly halted this week following two patient deaths, raising questions about a closely-watched approach to cancer that involves reprogramming cells to seek and destroy the disease. In response, the US Food and Drug Administration has ordered a temporary halt to the trial.

“We’re still learning to use them in the safest, most efficacious way”, said Bishop. The FDA wants Juno to revise its patient consent forms, investigative brochure, trial protocol, and a presentation it made to the FDA yesterday. However, shares of Kite Pharma were trading lower Friday, recently down 9.4 percent at $47.20.

The world’s biggest tech company forgot to show you something, but a few Wall Street analysts and the Fool didn’t miss a beat: There’s a small company that’s powering their brand-new gadgets and the coming revolution in technology. The announcement came after Juno reported 2 additional deaths last week of patients enrolled in the death, following the death of 1 patient back in May.