SEATTLE–(BUSINESS WIRE)–Juno Therapeutics, Inc. (Nasdaq: JUNO), a biopharmaceutical aggregation focused on re-engaging the body’s allowed arrangement to accommodate the analysis of cancer, today appear that the U.S. Food and Drug Administration has removed the analytic authority on the Phase II analytic balloon of JCAR015 (known as the “ROCKET” trial) in developed patients with relapsed or adverse B corpuscle astute lymphoblastic leukemia (r/r ALL).
Under the revised protocol, the ROCKET balloon will abide acceptance application JCAR015 with cyclophosphamide pre-conditioning only.
Juno Therapeutics is architecture a absolutely chip biopharmaceutical aggregation focused on re-engaging the body’s allowed arrangement to accommodate the analysis of cancer. Founded on the eyes that the use of animal beef as ameliorative entities will drive one of the aing important phases in medicine, Juno is developing cell-based blight immunotherapies based on chimeric antigen receptor and high-affinity T corpuscle receptor technologies to genetically architect T beef to admit and annihilate cancer. Juno is developing assorted cell-based artefact candidates to amusement a array of B-cell malignancies as able-bodied as solid tumors. Several artefact candidates accept apparent acute analytic responses in analytic trials in adverse leukemia and lymphoma conducted to date. Juno’s abiding aim is to advantage its cell-based belvedere to advance new artefact candidates that abode a broader ambit of cancers and animal diseases. Juno brings calm avant-garde technologies from some of the world’s arch analysis institutions, including the Fred Hutchinson Blight Analysis Center, Memorial Sloan Kettering Blight Center, Seattle Children’s Analysis Institute, and The National Blight Institute. Juno Therapeutics has an absolute authorization to the St. Jude Children’s Analysis Hospital patented technology for CD19 directed artefact candidates that use 4-1BB, which was developed by Dario Campana, Chihaya Imai, and St. Jude Children’s Analysis Hospital.
This columnist absolution contains “forward-looking statements” aural the acceptation of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, and Section 21E of the Securities Exchange Act of 1934, including statements apropos Juno’s mission, progress, and business plans, and the timing and conduct of the ROCKET trial. Advanced statements are accountable to risks and uncertainties that could account absolute after-effects to alter materially from such advanced statements, and appear after-effects should not be advised as an adumbration of approaching performance. These risks and uncertainties include, but are not bound to, risks associated with: the success, cost, and timing of Juno’s artefact development activities and analytic trials; Juno’s adeptness to access authoritative approval for and to commercialize its artefact candidates; Juno’s adeptness to authorize a commercially-viable accomplishment action and accomplishment infrastructure; authoritative requirements and authoritative developments; success of Juno’s competitors with account to aggressive treatments and technologies; Juno’s assurance on third-party collaborators and added contractors in Juno’s analysis and development activities, including for the conduct of analytic trials and the accomplish of Juno’s artefact candidates; Juno’s assurance on Celgene for the development and commercialization alfresco of North America and China of Juno’s CD19 artefact candidates and any added artefact candidates for which Celgene contest an option; Juno’s assurance on JW Therapeutics (Shanghai) Co., Ltd, over which Juno does not exercise complete control, for the development and commercialization of artefact candidates in China; Juno’s adeptness to obtain, maintain, or assure bookish acreage rights accompanying to its artefact candidates; amongst others. For a added description of the risks and uncertainties that could account absolute after-effects to alter from those bidding in these advanced statements, as able-bodied as risks apropos to Juno’s business in general, see Juno’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 10, 2016, and Juno’s added alternate letters filed with the Securities and Exchange Commission. These advanced statements allege alone as of the date hereof. Juno disclaims any obligation to amend these advanced statements.
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