Juno To Present Key Clinical Data Updates On JCAR017 And JCAR014 At The 2017 ASCO Annual Meeting

SEATTLE--(BUSINESS WIRE)--Juno Therapeutics, Inc. (NASDAQ: JUNO), a biopharmaceutical company developing innovative cellular immunotherapies for the treatment of cancer, today announced that it will present key clinical updates in partnership with its collaborators on its investigational products JCAR017 and JCAR014 at the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting 2017 in Chicago, Illinois, June 2-6.

JCAR017 and JCAR014 are chimeric antigen receptor (CAR) T cell product candidates that target CD19, a protein expressed on the surface of almost all B cell malignancies, including non-Hodgkin lymphoma (NHL), chronic lymphocytic leukemia (CLL), and acute lymphoblastic leukemia (ALL). While the manufacturing process and final cell product differ, both product candidates utilize the 4-1BB co-stimulatory domain and use a defined cell manufacturing process, controlling the type of cells a patients receives with the goal of delivering an improved therapeutic benefit. Insights from studies of the translational product JCAR014 are being applied to the development of JCAR017.

New data from the ongoing Phase I TRANSCEND NHL 001 trial (NCT02631044) evaluating JCAR017 in adult patients with relapsed or refractory aggressive NHL [diffuse large B cell lymphoma (DLBCL), primary mediastinal B cell lymphoma (PMBCL), follicular lymphoma Grade 3B, and mantle cell lymphoma (MCL)] will be presented, with increased patient numbers and longer duration of follow-up reported at two dose levels as compared to previous presentations. Updated safety data will also be presented from the ongoing Phase I trial (NCT01865617) evaluating JCAR014 in adult patients with relapsed or refractory ALL, NHL, or CLL. The JCAR014 presentation will also include data on clinical and laboratory biomarkers that may allow early identification of cytokine release syndrome (CRS) and neurotoxicity (NT).

Key data presentations at ASCO include:

JCAR017

• CR Rates in Relapsed/Refractory (R/R) Aggressive B-NHL Treated with the CD19-Directed CAR T Cell Product JCAR017 (TRANSCEND NHL 001) (Abstract #7513)
  • Presenter: Jeremy Abramson, M.D., Massachusetts General Hospital
  • Poster Display & Location: Monday, June 5, 2017: 8:00 – 11:30 a.m. Central Time; Hall A, Poster Board #275
  • Poster Discussion & Location: Monday, June 5, 2017: 1:15 – 2:30 p.m. Central Time; Room E354b

JCAR014

• Cytokine Release Syndrome (CRS) and Neurotoxicity (NT) after CD19-Specific Chimeric Antigen Receptor-Modified T cells (Abstract #3020)
  • Presenter: Kevin Hay, M.D., MSc, Fred Hutchinson Cancer Research Center
  • Poster Display & Location: Monday, June 5, 2017: 8:00 – 11:30 a.m. Central Time; Hall A, Poster Board #115
  • Poster Discussion & Location: Monday, June 5, 2017: 4:45 – 6:00 p.m. Central Time; Hall D1

About Juno’s Chimeric Antigen Receptor and T Cell Receptor Technologies

Juno’s CAR and TCR technologies 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. JCAR014 and JCAR017 are investigational product candidates and their safety and efficacy have not been established. They are not approved by any regulatory authority.

About Juno

Juno Therapeutics is building a fully integrated biopharmaceutical company focused on developing innovative cellular immunotherapies for the treatment of 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 multiple solid tumors. Several product candidates have shown compelling clinical responses in clinical trials in refractory leukemia and lymphoma conducted to date. Juno's long-term aim is to 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 (SCRI), the University of California, San Francisco, and The National Cancer Institute. Juno Therapeutics has an exclusive license to the St. Jude Children’s Research Hospital patented technology for CD19-directed product candidates that use 4-1BB, which was developed by Dario Campana, Chihaya Imai, and St. Jude Children’s Research Hospital. Juno’s product candidate JCAR017 was developed in collaboration with SCRI and others.

About the Juno-Celgene Collaboration

Celgene Corporation and Juno Therapeutics formed a collaboration in June 2015, under which the two companies will leverage T cell therapeutic strategies to develop treatments for patients with cancer and autoimmune diseases with an initial focus on chimeric antigen receptor (CAR) and T cell receptor (TCR) technologies. In April 2016, Celgene exercised its option to develop and commercialize the Juno CD19 program outside North America and China.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning 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 regarding Juno’s mission, progress, clinical benefits, clinical trial results and the implications thereof, planned presentations at ASCO, clinical trial plans, emerging medical trends, and the potential of biomarkers to allow early identification of serious toxicities. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from such forward-looking statements, 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 Juno's product development activities and clinical trials; Juno's ability to obtain regulatory approval for and to commercialize its product candidates; Juno's ability to establish a commercially-viable manufacturing process and manufacturing infrastructure; regulatory requirements and regulatory developments; success of Juno's competitors with respect to competing treatments and technologies; Juno's dependence on third-party collaborators and other contractors in Juno's research and development activities, including for the conduct of clinical trials and the manufacture of Juno's product candidates; Juno's dependence on Celgene for the development and commercialization outside of North America and China of Juno’s CD19 product candidates and any other product candidates for which Celgene exercises an option; Juno’s dependence on JW Biotechnology (Shanghai) Co., Ltd, over which Juno does not exercise complete control, for the development and commercialization of product candidates in China; Juno's ability to obtain, maintain, or protect intellectual property rights related to its product candidates; amongst others. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Juno's business in general, see Juno's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 4, 2017 and Juno’s other periodic reports filed with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof. Juno disclaims any obligation to update these forward-looking statements.