Juno Stock Falls Again After Correcting Number of Trial Deaths
July 15, 2016
By Mark Terry, BioSpace.com Breaking News Staff
Seattle-based Juno Therapeutics has been balanced on a knife’s edge this last week, as bad news was followed by good news followed by bad. Company stock responded accordingly, dropping and rising and dropping again right along with the news.
On Friday, July 8, the company announced the U.S. Food and Drug Administration (FDA) had placed a clinical hold on its Phase II clinical trial of JCAR015 for relapsed or refractory B cell acute lymphoblastic leukemia after three patient deaths. All three patients died from cerebral edema, a fluid buildup in the brain.
On Tuesday, July 12, Juno announced that after modifying the trial protocols, the FDA had approved continuation of the trial.
Yesterday, July 14, the company made a correction, indicating that instead of three patient fatalities out of 129 cases, there were actually four. After Tuesday’s stock jump, the market plummeted again.
In a filing with the SEC, Juno said, “Dr. Gilbert mistakenly said ‘three’ cases out of 129 rather than ‘four’ cases. The fourth case was a patient treated in the JCAR014 trial.”
Mark Gilbert, Juno’s chief medical officer, had made the comments during an investors conference call on July 12. As pointed out in Investor’s Business Daily News, “The transcript, however, noted that a fourth patient had died last year in a trial of a different CAR-T therapy, JCAR014. This was ‘included in the data presented in an oral presentation at the American Society of Hematology meeting in December 2015, and included in Juno’s Annual Report on Form 10-K for the fiscal year ended December 31, 2015.’”
Juno’s CAR-T therapies involve taking T-cells from the blood of cancer patients, genetically engineering them to attack the patient’s specific tumors, using chemotherapy to kill the existing T-cells, then infusing the new T-cells back into the patient. For most of the trial’s course, the chemotherapy cocktail utilized cytoxan. Because the new T-cells seemed to take hold better when fludarabine was added to the chemotherapy cocktail, Juno added that midway through the trial. The deaths of the three patients—apparently now four—seems to be related to the addition of fludarabine.
Although there are several other companies working to break into the CAR-T space, including Bluebird Bio and Ziopharm Oncology , the two leaders are Juno and Kite Pharma . Kite’s KTE-C19, a possible treatment for aggressive non-Hodgkin lymphoma, seems to be further ahead than Juno, but its stock had mirrored Juno’s over the last week or so.
Biren Amin, an analyst with Jefferies, indicated in a note to investors that this new information probably won’t have a major effect on Kite. “At the time, this (JCAR014 death) was not linked to a Juno-sponsored clinical trial, making it difficult to evaluate the fludarabine/cyclophosphamide regimen used in this patient and other conditions relevant to the event. But we now know that all four patient deaths involved Juno’s constructs. Critically, we also know that a flu/cy regimen much higher than what Kite uses in their trials (roughly four times more cy for ALL patients) was involved in all four cerebral edema cases.”
Juno Therapeutics is currently trading for $28 per share.
Kite Pharma is currently trading for $47.97.
Juno also announced yesterday that it had acquired RedoxTherapies, a privately held company in Boston for $10 million in cash up front and various undisclosed clinical, regulatory and commercial milestone payments. As part of the deal, Juno acquires an exclusive license to vipadenant, a small molecule adenosine A2a receptor antagonist that appears to disrupt immunosuppressive pathways in tumors in some cancers.