Seattle cancer clinical trials partner, Juno Therapeutics, granted FDA Breakthrough Therapy Designation

Juno Therapeutics today announced that the FDA has granted Breakthrough Therapy Designation to the company’s JCAR015 chimeric antigen receptor product candidate. The designation applies for the treatment of relapsed or refractory B-cell acute lymphoblastic leukemia and was filed by Juno’s collaboration partner, Memorial Sloan Kettering Cancer Center, where Phase 1 clinical trials are currently underway.

“The FDA’s action is important news for patients who may benefit from the accelerated development of JCAR015 and is an important moment for the field of cancer immunotherapy, which has the potential to meet the need for more effective treatments in a range of cancers,” said Juno CEO Hans Bishop.

The FDA’s Breakthrough Therapy Designation was created to help accelerate the development and review of new drugs for serious or life-threatening conditions. The designation comes with potential benefits, including intensive FDA guidance and eligibility for priority review. It is granted to applicants when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinical endpoints.

All three of Juno’s CAR T cell product candidates currently in clinical trials, including JCAR015, are based on chimeric antigen receptor technology that employs the body’s immune system to attack cancer cells. JCAR017 is being tested at Seattle Children’s Hospital for relapsed/refractory CD19-positive pediatric leukemia. JCAR014 is being tested for refractory chronic lymphocytic leukemia, non-Hodgkin’s lymphoma and acute lymphoblastic leukemia at the Fred Hutchinson Cancer Research Center in Seattle, WA. Data on these programs will be presented at the 54th Annual Meeting of the American Society of Hematology meeting next week in San Francisco.

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. Juno is developing multiple cell-based product candidates to treat a variety of B-cell malignancies as well as solid tumors. Several product candidates have shown compelling evidence of tumor shrinkage in the clinical trials in refractory leukemia and lymphoma conducted to date. 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.