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Juno Therapeutics to Highlight New Advances in CD19- and BCMA-Targeted CAR T Therapy at ASH

SEATTLE--(BUSINESS WIRE)--

Juno Therapeutics, Inc. (JUNO), a biopharmaceutical company developing innovative cellular immunotherapies for the treatment of cancer, today announced that 15 abstracts detailing updated clinical and preclinical results from the company and its collaborators will be presented at the 59th American Society of Hematology (ASH) Annual Meeting. Senior executives will also review results and provide an update on Juno’s clinical development program at an analyst and investor event, which will also be available via webcast.

“The presentations at ASH will showcase promising data coming from our pipeline of CD19- and BMCA-directed CAR T cell product candidates,” said Sunil Agarwal, M.D., Juno's President of Research and Development. "Results from the ongoing TRANSCEND study of JCAR017 in adults with aggressive lymphoma help advance understanding of cell therapy, providing new insights into the differentiation between CAR T products now reaching the market and Juno’s next-generation JCAR017, which we believe could offer a best-in-class clinical profile.”

Updated data from the TRANSCEND study of JCAR017 in patients with relapsed or refractory (r/r) aggressive B-cell non-Hodgkin lymphoma (NHL) will be presented by Principal Investigator Jeremy Abramson, M.D., of the Massachusetts General Hospital, on December 11. The presentation will include new information on enrollment, safety, response rates, duration of response, and overall survival.

The primary TRANSCEND abstract released today includes data from the core analysis group (N=49), which includes patients that represent the population that Juno is studying in the ongoing pivotal cohort. The core group includes patients with DLBCL (NOS and transformed from follicular lymphoma) who are ECOG Performance Status 0-1. These patients represent a highly refractory population based on some key factors that are associated with a poor prognosis including an older age, having a double or triple hit, and being chemorefractory.

Topline data from the abstract for both dose levels for the core group as of a data cutoff date of July 7, 2017 included:

  • Dose level 2 (DL2 = 100 million cells), the dose in the pivotal cohort for the TRANSCEND study, showed a 3 month overall response rate (ORR) of 80% (12/15) and a 3 month complete response (CR) rate of 73% (11/15) in the core group. Data support a dose response relationship. Dose level 1 (DL1 = 50 million cells) showed 3 month ORR of 52% (11/21) and a 3 month CR rate of 33% (7/21).
  • Across both doses in the core group, the best overall response was 84% (41/49) and the best overall CR rate was 61% (30/49).
  • There was no increase in cytokine release syndrome (CRS) and neurotoxicity (NT) rates associated with the higher dose or between the full and core groups. Across doses in the full group, 1% (1/69) experienced severe CRS and 14% (10/69) experienced severe NT. 30% (21/69) had any grade CRS and 20% (14/69) had any grade NT. 64% (44/69) had no CRS or NT.
  • The most common treatment-emergent adverse events other than CRS and NT that occurred at ≥25% in the full group included neutropenia (41%), fatigue (30%), thrombocytopenia (30%), and anemia (26%).

JCAR017 is a defined composition CD19-directed CAR T cell product candidate using a 4-1BB costimulatory domain. Juno believes JCAR017’s clinical profile could enable outpatient administration.

ASH Investor and Analyst Event and Webcast

The Juno ASH Investor and Analyst Event and webcast will be held Monday, December 11, 2017 at 8:30 p.m. Eastern Time. The webcast can be accessed live on the Investor Relations page of Juno’s website, www.JunoTherapeutics.com, and will be available for replay for 30 days following the event.

A complete list of Juno and collaborator presentations to be made at ASH appears below.

Juno Oral Presentations

Patient Characteristics and Pre-Infusion Biomarkers of Inflammation Correlate with Clinical Outcomes after Treatment with the Defined Composition, CD19-Targeted CAR T Cell Product, JCAR017 (Abstract #193)

Presenter: Tanya Siddiqi, M.D., City of Hope National Medical Center
Date: Saturday, December 9, 2017, 2:00 p.m. Eastern Time
Location: Georgia World Congress Center, Building C, Level 1, C101 Auditorium

Predicting Clinical Response and Safety of JCAR017 in B-NHL Patients: Potential Importance of Tumor Microenvironment Biomarkers and CAR T-Cell Tumor Infiltration (Abstract #194)

Presenter: Howard Stern, M.D., Ph.D., Juno Therapeutics
Date: Saturday, December 9, 2017, 2:15 p.m. Eastern Time
Location: Georgia World Congress Center, Building C, Level 1, C101 Auditorium

High Durable CR Rates in R/R Aggressive B-NHL Treated with JCAR017 (TRANSCEND NHL 001): Defined Composition CD19-Directed CAR T Cell Product Allows for Dose Finding and Definition of Pivotal Cohort (Abstract #581)

Presenter: Jeremy S. Abramson, M.D., Massachusetts General Hospital Cancer Center
Date: Monday, December 11, 2017, 8:00 a.m. Eastern Time
Location: Georgia World Congress Center, Building A, Level 4, A411-412

Development of JCARH125: Optimization of a fully human anti-BCMA CAR for use in the treatment of Multiple Myeloma (Abstract #1813)

Presenter: Kim Harrington, Juno Therapeutics
Date: Saturday, December 9, 2017, 5:30 p.m. Eastern Time
Location: Georgia World Congress Center, Building A, Level 1, Hall A2

Inhibiting TGFβ signaling in CAR T-cells may significantly enhance efficacy of tumor immunotherapy (Abstract #1791)

Presenter: Queenie Vong, Ph.D., Juno Therapeutics
Date: Saturday, December 9, 2017, 5:30 p.m. Eastern Time
Location: Georgia World Congress Center, Building A, Level 1, Hall A2

Lenalidomide Enhances Anti-BCMA Chimeric Antigen Receptor T cell Function Against Multiple Myeloma (Abstract #1794)

Presenter: Melissa Works, Ph.D., Juno Therapeutics
Date: Saturday, December 9, 2017, 5:30 p.m. Eastern Time
Location: Georgia World Congress Center, Building A, Level 1, Hall A2

Preliminary Safety Profile of the CD19-Directed Defined Composition CAR T Cell Product JCAR017 in Relapsed/Refractory Aggressive B-NHL Patients: Potential for Outpatient Administration (Abstract #1552)

Presenter: David Maloney, M.D., Ph.D., Fred Hutchinson Cancer Research Center
Date: Saturday, December 9, 2017, 5:30 p.m. Eastern Time
Location: Georgia World Congress Center, Building A, Level 1, Hall A2

Pharmacokinetic, Pharmacodynamic and Blood Analytes Associated with Clinical Response and Safety in Relapsed/Refractory Aggressive B-NHL Patients Treated with JCAR017 (Abstract #2385)

Presenter: Mark Heipel, Juno Therapeutics
Date: Sunday, December 10, 2017, 6:00 p.m. Eastern Time
Location: Georgia World Congress Center, Building A, Level 1, Hall A2

JCAR017 is a Defined Composition CAR T Cell Product with Product and Process Controls That Deliver Precise Doses of CD4 and CD8 CAR T Cells to Patients with NHL (Abstract #4471)

Presenter: Chris Ramsborg, Juno Therapeutics, Inc.
Date: Monday, December 11, 2017, 6:00 p.m. Eastern Time
Location: Georgia World Congress Center, Building A, Level 1, Hall A2

Academic and Collaborator Presentations

Beyond Cytokine Storm: Optimizing Treatment Strategies to Target the Complex Interplay Between CAR Mediated Inflammatory Response, Disseminated Intravascular Coagulation and Macrophage Activation Syndrome (Abstract #1277)

Presenter: Nirali Shah, M.D., Pediatric Oncology Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health
Date: Saturday, December 9, 2017, 5:30 p.m. Eastern Time
Location: Georgia World Congress Center, Building A, Level 1, Hall A2

Development and Evaluation of a Human Single Chain Variable Fragment (scFv) derived BCMA Targeted CAR T Cell Vector Leads to a High Overall Response Rate in Patients with Advance Multiple Myeloma (Abstract #742)

Presenter: Eric Smith, M.D., Ph.D., Memorial Sloan Kettering Cancer Center
Date: Monday, December 11, 2017, 3:30 p.m. Eastern Time
Location: Georgia World Congress Center, Building C, Level 1, Hall C1

Endothelial Activation and Blood-Brain Barrier Disruption in Neurotoxicity after CD19 CAR-T Cell Immunotherapy (Abstract #805)

Presenter: Cameron Turtle, M.B.B.S., Ph.D., Fred Hutchinson Cancer Research Center
Date: Monday, December 11, 2017, 4:30 p.m. Eastern Time
Location: Georgia World Congress Center, Building C, Level 1, Hall C4

CD4/CD8 T-Cell Selection Improves CD22 CAR-T Cell Transduction In-Vivo CAR-T Expansion: Updated Results on Phase I Anti-CD22 CAR Dose Expansion Cohort (Abstract TBD)

Presenter Nirali Shah, M.D., Pediatric Oncology Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health
Date: Monday, December 11, 2017, 5:30 p.m. Eastern Time
Location: Georgia World Congress Center, Building C, Level 1, Hall C4

Intensification of Lymphodepletion Enhances CAR Expansion After Re-Infusion (Abstract #3889)

Presenter: Haneen Shalabi, D.O., Pediatric Oncology Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health
Date: Monday, December 11, 2017, 6:00 p.m. Eastern Time
Location: Georgia World Congress Center, Building A, Level 1, Hall A2

Presenter: Haneen Shalabi, D.O., Pediatric Oncology Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health
Date: Monday, December 11, 2017, 6:00 p.m. Eastern Time
Accepted for publication in Abstract Book

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 and multiple myeloma. 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, and business plans; Juno’s participation at ASH and the content of ASH presentations; the potential best-in-class profile for JCAR017 and the potential for outpatient administration; and the implications of clinical data. 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 ability to attract and retain key scientific, quality control/assurance, manufacturing or management personnel; 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 Therapeutics (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 the information Juno has included in its periodic reports and other documents 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.


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