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Biotech / Medical : Juno Therapeutics Inc. (JUNO)

JUNO 86.96

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Mar 6 4:00 PM EST

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From: Julius Wong	6/5/2016 8:15:12 PM
	of 84

Juno's CAR-T candidates continue to show positive results in treatment-resistant blood cancers Juno Therapeutics (NASDAQ: JUNO) reports encouraging results from two early-stage studies assessing two CAR-T candidates in its CD19 program. The results were presented yesterday at ASCO16 in Chicago. Results from a randomized Phase 1/2 study assessing JCAR014 in patients with relapsed/refractory acute lymphoblastic leukemia (ALL) showed a 100% (n=34/34) complete remission rate in efficacy-evaluable subjects and a 94% (n=32/34) complete remission rate as measured by flow cytometry. In the group that receive the chemo regimen fludarabine/cyclophosphamide (Flu/Cy) as a pretreatment, the complete response rate was also 100% (n=22/22) both clinically and by flow cytometry. Median disease-free survival and overall survival have not been reached in the 18 months of follow up. In patients with non-Hodgkin lymphoma, mainly diffuse large B-cell lymphoma, who received the Flu/Cy pretreatment followed by JCAR014, the overall response rate was 80% (n=16/20) and the complete response rate was 50% (n=10/20). Treatment-related side effects continue to be substantial. Serious cytokine release syndrome (sCRS) or "cytokine storm", a serious and potentially life-threatening immune response, was observed in 39% (n=14/36) of patients and grade 3 (severe) or higher neurotoxicity was observed in 39% (n=14/36). Results from an ongoing Phase 1 trial evaluating JCAR017 in pediatric and young adult patients with CD19-positive relapsed/refractory ALL showed a complete remission rate of 93% (n=39/42) both clinically and as measured by flow cytometry as did those receiving the Flu/Cy pretreatment (n=14/14). The incidence rates of sCRS and grade 3 or higher neurotoxicity were both 24% (n=10/42). The company and Celgene (NASDAQ: CELG) are partnering on the development and commercialization of Juno's CD19 program. Juno retains exclusive rights in North America and China and Celgene elsewhere.

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