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BIOTECH · @_B_I_O_T_E_C_H_

23rd Nov 2016 from TwitLonger

GS $JUNO $KITE $ZIOP $SGMO $CLLS $BLCM - JUNO ROCKET study back on hold; no read-through to other CAR Ts
JUNO (Neutral): ROCKET pivotal study back on clinical hold
JUNO's lead CAR T, JCAR015 in adult leukemia (ALL), was placed on
voluntary clinical hold following two deaths (2/12 patients) earlier this week
due to drug-related neurotoxicity (cerebral edema). This follows a prior
clinical hold in July also due to drug-related deaths from cerebral edema,
which JUNO suspected were in part caused by the addition of fludarabine
(flu) to the preconditioning regimen and was subsequently removed. Going
forward, JUNO notes three possible options for JCAR015: (1) proceeding
under a modified protocol; (2) initiating a new study; and (3) terminating
the program. Also, management confirmed no treatment-related deaths
have been observed in the JCAR017 trials (pediatric ALL and NHL) and
those in the JCAR014 study are limited to prior-used doses. In our view,
while management restated their view that the mechanism of neurotoxicity
is likely multifactorial and driven by rapid cell expansion, it appears their
understanding of the pathophysiology remains limited. We await potential
clarity on next steps for JCAR015 at the ASH analyst event (Dec 5);
however, given the lack of mechanistic clarity (not a site-specific issue,
manufacturing remains a possibility) and JCAR017’s superior safety profile
to date, we view the path forward for JCAR015 as challenging and remove
the program from our model (p. 2). Our new 12-month PT is $24 ($32 prior).
KITE (Buy): Little read-through to KTE-C19
KITE has not reported any drug-related deaths due to cerebral edema to
date, including the Ph1 NCI study in adult ALL (Lancet 2014). While severe
neurotoxicity has been observed in the KTE-C19 pivotal study in NHL (34%
per top-line), drug-related deaths (2/62) have been due to cytokine release
syndrome. Overall, we believe the risk/benefit profile favors KTE-C19.
BLUE (CL-Buy): No impact to BCMA program
We see no read-through to BLUE’s lead CAR T, bb2121 (not in our model),
in multiple myeloma and believe a favorable safety profile is being seen
given the EORTC-NCI-AACR abstract title (“Clinical remissions and limited
toxicity…”). We look for full data at the meeting on Dec 1.
CELG (Sell): JUNO program is not in our numbers
We do not include revenue for JCAR-015 in our CELG model, so there is no
potential downside risk to our estimates. But, in our view, today’s clinical
hold again highlights the development risk in many of CELG’s early-stage
partnered programs.

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