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Expert Financial Analysis and Reporting

Juno Therapeutics: FDA Quickly Lifts Its Clinical Hold on ROCKET

The FDA has decided to lift the clinical hold on the ROCKET trial. Lifting the hold is not a great surprise but the quick turnaround is. This is a strong signal from the FDA that it views the troublesome side effects of CAR-T therapy to be an acceptable risk when weighed against its dramatic therapeutic responses.

This is the best case scenario for Juno although the neurotoxicity (cerebral edema) that led to 3 deaths out of 20 patients treated in the ROCKET trial needs to be very closely examined. Juno originally hypothesized that the inclusion of fludaribine in the pre-conditioning program was a major contributing factor by causing more rapid expansion of CAR-T cells in vivo. It may also be the case that there is some unique characteristic of adult r/r ALL that increases risk. These seem the most likely causes, but we are at the very early stage of understanding the biology and there could be other factors that are currently not readily apparent

While this is the best case scenario for Juno, there are still some negatives. The IRBs (institutional review boards) at each enrolling institution will need to process this information before enrollment is resumed and this could take some time. Also Juno had proposed that if the clinical hold were to be lifted that enrollment would be slowed and a careful look would be taken at the first five or six patients. Hence there is going to be a delay in completion of the trial but it is likely only to be a few months at worst. Juno said last week that a 2018 approval timeline was more likely than a 2017 timeline. ManagementĀ is likely to give an update during the 2Q, 2016 conference call in August.

I am working on a more comprehensive report on the CAR-T space in which I address the negatives and positives. My work leads me to believe that the current market valuations of Juno and Kite are based on best case scenarios. I am avoiding both stocks.


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1 Comments

  1. Larry, what is your opinion about JUNO and KITE competitors — BLUE, CLLS, BLCM, ADAP?
    BLCM and ADAP valuation seems more reasonable than those of KITE and JUNO. Also if my knowledge is correct, BLCM, ADAP, CLLS have a suicide switch in case of a cytokine storm, technology that both JUNO and KITE lack.
    Thanks in advance
    igal-igor

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