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Juno's Investigational CAR T Cell Product Candidate JCAR015 Demonstrates Encouraging Clinical Responses in Patients With B-Cell Cancers

SEATTLE, May 30, 2015 (GLOBE NEWSWIRE) -- Juno Therapeutics, Inc. (Nasdaq:JUNO) announced today that clinical data from its most advanced chimeric antigen receptor (CAR) T cell product candidate, JCAR015, demonstrated encouraging clinical responses in acute lymphoblastic leukemia (ALL). Clinical results will be presented in an oral presentation today at the 2015 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago.

"We are encouraged by the continued positive results of JCAR015 in patients with ALL," said Mark Frohlich, M.D., Juno EVP of development and portfolio strategy. "We look forward to continuing to advance this candidate into a potential registration trial and make it broadly available to patients."

In an oral presentation on Saturday, May 30, 2015 by Jae H. Park, M.D. of Memorial Sloan Kettering Cancer Center entitled, "Efficacy and safety of CD19-targeted 19-28z CAR modified T cells in adult patients with relapsed or refractory B-ALL", updated Phase I results in 39 adult patients treated with JCAR015 will be reported in this ongoing trial:

  • Complete remission (CR) was reported in 33/38 (87%) of evaluable patients and minimal residual disease (MRD) negative CR was reported in 26/32 (81%) of patients who achieved a CR.
  • Median overall survival (OS) for all efficacy evaluable patients (N=38) was 8.5 months, and the 6 month OS rate was 59% (95% CI: 39-74).
  • Durable responses were observed in patients with and without subsequent allogeneic stem cell transplant.
  • Severe cytokine release syndrome (CRS) was observed in 9/39 (23%) of patients. Severity of CRS correlated with disease burden and was generally reversible. Grade 3/4 neurotoxicity was observed in 11/39 (28%) of patients. Grade 5 toxicity was observed in 3/39 (8%) of patients, and assessed to be unrelated to JCAR015 treatment in one of these patients.

About Juno's Chimeric Antigen Receptor (CAR) and T Cell Receptor (TCR) Technologies

Juno's chimeric antigen receptor (CAR) and T cell receptor technologies (TCR) genetically engineer T cells to recognize and kill cancer cells. Juno's CAR T cell technology inserts a gene for a particular CAR into the T cell, enabling it to recognize cancer cells based on the expression of a specific protein located on the cell surface. Juno's TCR technology provides the T cells with a specific T cell receptor to recognize protein fragments derived from either the surface or inside the cell. When either type of engineered T cell engages the target protein on the cancer cell, it initiates a cell-killing response against the cancer cell.

About Juno Therapeutics, Inc.

Juno Therapeutics 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. Juno'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 some of the world's leading research institutions, including the Fred Hutchinson Cancer Research Center, Memorial Sloan Kettering Cancer Center, Seattle Children's Research Institute, and The National Cancer Institute.

Juno Forward Looking Statements

This press release contains forward-looking statements, including statements regarding the clinical development of our product candidates, the safety and efficacy of our product candidates, the possibility of a registration trial and timing thereof, and the eventual availability of our product candidates to patients, broadly or otherwise. 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.

CONTACT: Investor Relations: David Walsey, W2O Group 858-617-0772 dwalsey@w2ogroup.com Media: Julie Normart, W2O Group 415-946-1087 jnormart@w2ogroup.com

Source:Juno Therapeutics