Wednesday, 22 November, 2017

FDA stops Juno's cancer drug trials after 3 patients die

After hours Wall Street end of day exterior Lucas Jackson | Reuters
Sammy Stanley | 12 July, 2016, 06:33

Yes, the driver behind the hold is tragic, but there has never been a better opportunity to pick up an exposure to either Juno or CART. JCAR015 is in Phase I open label clinical trial stage for patients with relapsed or refractory acute lymphoblastic leukemia (r/r ALL).

Michel Sadelain, the scientist at Memorial Sloan Kettering Cancer Center in NY who originally developed the t cell treatment being tested by Juno, says he only learned of the deaths this week. However, they "sensitized" their model and explain that if they remove all sales from Juno Therapeutics' adult ALL program from it, their price target could fall by about 16%. In this particular course of treatment, pre-conditioning consists of a heavy dose of chemotherapy to kill off existing cancer cells in order to give the new, cancer-killing T-cells room to grow.

According to a report in Forbes by Matthew Herper, "Three patients have died in a closely watched study of using genetically engineered white blood cells to treat adult leukemia patients, forcing the trial to be put on hold". There are around 20 patients now enrolled, and Juno hopes to enroll another 90 before trial end.

"This is a humbling experience", said Hans Bishop, Juno's chief executive officer, in a conference call.

Now, this is the important part.

"This sort of thing is incredibly common in new drug development".

The company did say that the deaths in these cases may be related to a very rapid expansion of the cells in the patients' bodies that it hasn't seen in other trials or with other pre-conditioning regimens. Lately, it has added a second drug known as fludarabine because the company feels that the dual drugs could make the treatment more effective. In response to a question by an analyst on the call, Gilbert pointed out that the 3 patients who died were young, under 25 years of age, and that they are investigating why that may be. The biotechnology startup has appealed to the FDA to continue the clinical trials without the use of fludarabine.

The United States Food and Drug Administration (FDA) placed a hold on the experimental cancer therapy called JCAR015 after the first patient died in May and two other patients died in late June. More importantly, it seems to relate to a combination that can easily be avoided on commercialization with some relatively non restrictive labeling. That's after Juno submits these documents, which it is slated to do next week.

"We conduct trials because we don't know an answer to something", he said. Kite shares declined more than 7% to as low as $48.39 during regular trading hours on Friday. Obviously, there might be something we don't know, but given now available information, that described above seems the most logical path forward.

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