Juno's JCAR015 Leukemia T Cell Therapy Granted Orphan Drug Designation By FDA

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Nov 18, 2014, 09:29 ET

SEATTLE, Nov. 18, 2014 /PRNewswire-USNewswire/ -- Juno Therapeutics, Inc. announced today that the FDA has granted Orphan Drug Designation to its JCAR015 chimeric antigen receptor product candidate. The designation was granted for treatment of acute lymphoblastic leukemia. JCAR015 Phase I trials are currently underway at Juno's collaboration partner, Memorial Sloan Kettering Cancer Center.

Orphan drug designations are granted to drugs intended to treat rare diseases or conditions, or "orphan" diseases. The designation allows for incentives to advance development and for marketing of drugs that progress to approval.

All three of Juno's CAR T cell product candidates currently in trial, including JCAR015, are based on chimeric antigen receptor technology that employs the body's immune system to attack cancer cells. JCAR017, in Phase I/II trials at Seattle Children's Hospital, is being tested for pediatric and young adult relapsed/refractory CD19 positive leukemia. JCAR014, currently in Phase I/II trials at the Fred Hutchison Cancer Research Center, is being tested for relapsed or refractory chronic lymphocytic leukemia, non-Hodgkin's lymphoma, and acute lymphoblastic leukemia.

About Juno
Juno Therapeutics, Inc. is building a fully integrated biopharmaceutical company focused on revolutionizing medicine by re-engaging the body's immune system to treat cancer. Founded on the vision that the use of human cells as therapeutic entities will drive one of the next important phases in medicine, Juno is developing cell-based cancer immunotherapies based on chimeric antigen receptor and high-affinity T cell receptor technologies to genetically engineer T cells to recognize and kill cancer cells. Juno is developing multiple cell-based product candidates to treat a variety of B-cell malignancies as well as solid tumors. Juno has shown compelling evidence of tumor shrinkage in clinical trials using multiple cell-based product candidates to address refractory B cell lymphomas and leukemias. The company's long-term aim is to improve and leverage its cell-based platform to develop new product candidates that address a broader range of cancers and human diseases. Juno brings together innovative technologies from three of the world's leading research institutions – the Fred Hutchinson Cancer Research Center, Memorial Sloan Kettering Cancer Center, and Seattle Children's Research Institute.

Forward Looking Statements
This press release contains forward-looking statements, including statements regarding the clinical development of our product candidates, the impact of the Orphan Drug Designation on the advancement and marketing of JCAR015, and the potential for immunotherapy to treat cancer and other indications. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially and reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to: risks associated with the success, cost and timing of our product development activities and clinical trials; the approval and commercialization of our product candidates; and risks of increased regulatory requirements; amongst others. These forward-looking statements speak only as of the date hereof. Juno Therapeutics disclaims any obligation to update these forward-looking statements.

www.JunoTherapeutics.com

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SOURCE Juno Therapeutics