Post by stcks on Jul 8, 2016 2:58:42 GMT
Thursday, July 7, 2016
Juno Therapeutics Inc. (NASDAQ:JUNO) fell $11.68 (29%) to $29.14 in early after-hours trading Thursday after FDA placed a clinical hold on the Phase II ROCKET trial of JCAR015 to treat relapsed or refractory acute lymphoblastic leukemia (ALL) following two patient deaths from cerebral edema. The product, Juno's most advanced program, is a chimeric antigen receptor T cell therapy targeting CD19.
Juno said a third ROCKET patient died with cerebral edema in May, but FDA and a DSMB concluded there were "confounding factors" and changes to the trial were not warranted as a result of that death.
On a conference call Thursday, Juno President and CEO Hans Bishop said the most likely contributor to the patient deaths was the addition of fludarabine to the study's preconditioning regimen. All three patients who died were receiving the purine nucleotide analog in combination with cyclophosphamide.
SVP and CMO Mark Gilbert said more than 20 patients had been treated in the study, with about a third receiving fludarabine and cyclophosphamide and the remainder receiving cyclophosphamide alone. He said the fludarabine/cyclophosphamide-treated patients showed a more rapid expansion of T cells than those who received cyclophosphamide alone, which contributed to the neurotoxicity.
The company said FDA asked for updated study protocol and consent documents. Juno expects to submit the information this week and hopes to hear back from the agency within 30 days of the submission.
On the call, Juno said the hold puts its prior guidance for accelerated approval of JCAR015 "at risk." In a May regulatory filing, Juno said ROCKET could support accelerated approval of JCAR015 "as early as 2017."
The company declined to provide an updated approval timeline.
Juno's disclosure put downward pressure on other T cell immunotherapy companies. In after-hours trading Thursday, Kite Pharma Inc. (NASDAQ:KITE) fell $4.34 to $47.76, bluebird bio Inc. (NASDAQ:BLUE) was down $2.65 to $46.18, Bellicum Pharmaceuticals Inc. (NASDAQ:BLCM) slid $0.71 to $14 and Ziopharm Oncology Inc. (NASDAQ:ZIOP) dropped $0.23 to $5.78.
Juno Therapeutics Inc. (NASDAQ:JUNO) fell $11.68 (29%) to $29.14 in early after-hours trading Thursday after FDA placed a clinical hold on the Phase II ROCKET trial of JCAR015 to treat relapsed or refractory acute lymphoblastic leukemia (ALL) following two patient deaths from cerebral edema. The product, Juno's most advanced program, is a chimeric antigen receptor T cell therapy targeting CD19.
Juno said a third ROCKET patient died with cerebral edema in May, but FDA and a DSMB concluded there were "confounding factors" and changes to the trial were not warranted as a result of that death.
On a conference call Thursday, Juno President and CEO Hans Bishop said the most likely contributor to the patient deaths was the addition of fludarabine to the study's preconditioning regimen. All three patients who died were receiving the purine nucleotide analog in combination with cyclophosphamide.
SVP and CMO Mark Gilbert said more than 20 patients had been treated in the study, with about a third receiving fludarabine and cyclophosphamide and the remainder receiving cyclophosphamide alone. He said the fludarabine/cyclophosphamide-treated patients showed a more rapid expansion of T cells than those who received cyclophosphamide alone, which contributed to the neurotoxicity.
The company said FDA asked for updated study protocol and consent documents. Juno expects to submit the information this week and hopes to hear back from the agency within 30 days of the submission.
On the call, Juno said the hold puts its prior guidance for accelerated approval of JCAR015 "at risk." In a May regulatory filing, Juno said ROCKET could support accelerated approval of JCAR015 "as early as 2017."
The company declined to provide an updated approval timeline.
Juno's disclosure put downward pressure on other T cell immunotherapy companies. In after-hours trading Thursday, Kite Pharma Inc. (NASDAQ:KITE) fell $4.34 to $47.76, bluebird bio Inc. (NASDAQ:BLUE) was down $2.65 to $46.18, Bellicum Pharmaceuticals Inc. (NASDAQ:BLCM) slid $0.71 to $14 and Ziopharm Oncology Inc. (NASDAQ:ZIOP) dropped $0.23 to $5.78.