Juno secured its second company sponsored IND for its CAR-T therapies. Importantly, given the many process changes madeto support this IND, thefact that FDA did not requireasafety run-in supports mgt.'s manufacturing investments. Weexpect JCAR015 datain late 2016 orearly 2017.
Juno announced that its IND for JCAR015 was cleared by the FDA:The PhII/III JCAR015 study will becalled ROCKET.This study is designed to evaluatetheefficacy of JCAR015 by assessing the overall responseratein patients with morphologicevidence of diseasefollowing chemotherapy.This study aims to enroll ~50 patients with morphologic disease(it will likely over enroll patients given that some patients with morphologic disease may not still haveitafter chemotherapy treatment).This study will also assess safety and tolerability.This study is scheduleto begin shortly and will likely read out in late 2016/early 2017.
Clear positive for JUNO given investor concerns: Many investors were concerned that Juno could faceissues or be delayed given therange of manufacturing changes that occurred to support thecompany sponsored IND (moving from an academic-based manufacturing process to one with commercial scale). Importantly, management has confirmed that thereis no run-in period to assess safety and that they may proceed directly to thefull scaleefficacy study.