Juno Therapeutics Executes License for Phase I CAR T Product Candidate Targeting CD22 for Hematological Malignancies

SEATTLE--Juno Therapeutics, Inc. today announced that it has entered into an agreement to obtain a license from Opus Bio, Inc. for a CAR-T cell product candidate targeting CD22, a protein expressed on most B cell leukemias and lymphomas. The CD22-targeted CAR T cell product candidate was developed by the National Cancer Institute (NCI) under cooperative research and development agreement (CRADA) with Opus Bio. The NCI has begun enrollment in a Phase I trial evaluating pediatric and young adult patients with relapsed/refractory acute lymphoblastic leukemia (ALL) or non-Hodgkin's lymphoma (NHL).

"This fully-human CD22 directed product candidate complements our existing CD19 directed portfolio, representing another important opportunity to investigate an immunotherapy addressing B cell malignancies," said Juno CEO, Hans Bishop.

The NCI-sponsored trial is designed to enroll patients with CD22 positive cancers, with both CD19 positive and CD19 negative patients eligible for treatment.

CAR T cells therapy has the potential to address an important unmet need, according to Crystal Mackall, M.D., Chief, Pediatric Oncology Branch, National Cancer Institute, National Institutes of Health. There is still much to learn about these immunotherapies, but the early results are hopeful.

Financial terms were not disclosed. The license will not become effective until certain closing conditions are satisfied, including obtaining consent from the NCI.

About Juno's Chimeric Antigen Receptor and High-affinity T Cell Receptor Platform

Juno is developing cell-based immunotherapies based on its chimeric antigen receptor, or CAR, and high-affinity T cell receptor, or TCR, platform to genetically engineer T cells to recognize and kill cancer cells. T cells are a type of white blood cell that identify and kill infected or abnormal cells, including cancer cells, in healthy individuals. Juno leverages its CAR and TCR platform to activate a patient's own T cells so that they attack cancer cells. Through genetic engineering, a gene is inserted for a particular CAR or TCR construct into the T cell enabling it to better recognize cancer cells. The CAR technology directs T cells to recognize cancer cells based on the expression of specific proteins located on the cell surface, whereas the 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. CAR construct typically uses a single chain variable fragment, or scFv, to recognize a protein of interest. The modified T cells can be infused into the patient or frozen and stored for later infusion.

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.


About Opus Bio

Opus Bio (formerly Lentigen Corporation) is a diversified biologics company focused on the development and commercialization of breakthrough treatments for human disease. Lentiviral vectors (LV), the company's technology platform, are widely recognized by the scientific community as the most efficient method for delivery of genetic sequence information into cells to reprogram their function. The ability to efficiently and stably reprogram mammalian cells has numerous uses in biotechnology and biomedicine, including drug discovery, target validation, biologics manufacturing and cellular therapies.


Forward Looking Statements

This press release contains forward-looking statements, including statements regarding the clinical development of our product candidates, the potential for immunotherapy to address unmet needs, and effectiveness of the license agreement with Opus Bio. 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; risks of increased regulatory requirements; and the satisfaction of conditions to the effectiveness of the license agreements, some of which are beyond the control of Juno and Opus Bio; amongst others. These forward-looking statements speak only as of the date hereof. Juno Therapeutics disclaims any obligation to update these forward-looking statements.


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