Juno Therapeutics (JUNO) Shows Positive Early Data In Leukemia Patients

Valuable Collaboration

With the positive results observed in the early stage study, JUNO along with its partner Celgene are taking the next step with respect to the JCAR014 drug. They both are wanting to combine JCAR014 together with ibrutinib. This is being done to see if the therapy of JCAR014 can be enhanced in a combination therapy with ibrutinib.

A phase 1 study of the combination therapies should start in early 2017. The landmark deal between JUNO and Celgene was announced back in June of 2015. At that time Celgene invested $1B in JUNO to develop cancer immunotherapies.

Potential Roadblock

JUNO achieving positive results in the CLL study is highly encouraging, except there is something that can put a stop to the advancement of the drug program. That roadblock is the fact that some patients experienced severe toxicity problems while taking the JCAR014 drug.

This means that the increased toxicity in this trial could translate to the possibility of the FDA placing a clinical hold on this trial as well. In addition, it will be difficult to obtain FDA approval with such adverse events. At least 2 of the 24 patients developed grade 3 to grade 5 cytokine release syndrome.

This is where a type of systemic inflammatory response occurs with respect to T-cells not being activated properly. To make matters worse at least 6 of the 24 patients achieved grade 3 to grade 5 neurotoxicity. Back in July the FDA had placed a clinical hold on a JUNO drug JCAR017 that was treating patients with relapsed or refractory B-cell acute lymphoblastic leukemia.

The trial was placed on hold due to two patient deaths after taking the experimental treatment. The FDA quickly released the hold a few days later which is the good news. The bad news is that JUNO itself had placed a hold in the trial again after patients experienced cerebral edema, and had later died.

This means that the JCAR017 trial has been halted two times already in one year due to severe toxicity concerns. This may spell further trouble for Juno’s other clinical CAR-T therapy programs.

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