"We are excited to present the primary analysis of ZUMA-1. The results
demonstrate the promise of anti-CD19 CAR T-cell therapy to transform
treatment of B-cell malignancies," said
Primary results from ZUMA-1: a pivotal trial of axicabtagene ciloleucel (axicel; KTE-C19) in patients with refractory aggressive non-Hodgkin lymphoma (NHL)
Immune signatures of cytokine release syndrome and neurologic events in a multicenter registrational trial (ZUMA-1) in subjects with refractory diffuse large B cell lymphoma treated with axicabtagene ciloleucel (KTE-C19)
Polyfunctional anti-CD19 CAR T cells determined by single-cell multiplex proteomics associated with clinical activity in patients with advanced non-Hodgkin's lymphoma
Development of KITE-585: A fully human BCMA CAR T-cell therapy for the treatment of multiple myeloma
Selectivity and specificity of engineered T cells expressing KITE-585, a chimeric antigen receptor targeting B-cell maturation antigen (BCMA)
About axicabtagene ciloleucel
Kite's lead product candidate, axicabtagene ciloleucel, is an investigational therapy in which a patient's T cells are engineered to express a chimeric antigen receptor (CAR) to target the antigen CD19, a protein expressed on the cell surface of B-cell lymphomas and leukemias, and redirect the T cells to kill cancer cells. Axicabtagene ciloleucel has been granted Breakthrough Therapy Designation status for diffuse large B-cell lymphoma (DLBCL), transformed follicular lymphoma (TFL), and primary mediastinal B-cell lymphoma (PMBCL) by the U.S. Food and Drug Administration (FDA) and Priority Medicines (PRIME) regulatory support for DLBCL in the EU.
KITE-585 is an investigational therapy in which a patient's T cells are engineered to express a chimeric antigen receptor (CAR) to target the B cell maturation antigen (BCMA), a protein expressed on the cell surface of multiple myelomas (MM), and redirect the T cells to kill cancer cells. In 2016, there were an estimated 30,330 new cases of MM and 12,650 disease related deaths in the US1. Current treatments, including multi-therapy combinations, require chronic care and most patients will eventually relapse2. Kite expects to file an Investigational New Drug Application (IND) for KITE-585 in 2017.
Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit www.kitepharma.com. Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma.
Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements for purposes of
the safe harbor provisions of the Private Securities Litigation Reform
Act of 1995. The press release may, in some cases, use terms such as
"predicts," "believes," "potential," "proposed," "continue,"
"estimates," "anticipates," "expects," "plans," "intends," "may,"
"could," "might," "will," "should" or other words that convey
uncertainty of future events or outcomes to identify these
forward-looking statements. Forward-looking statements include
statements regarding intentions, beliefs, projections, outlook, analyses
or current expectations concerning, among other things: the promise of
anti-CD19 CAR T cell therapy to transform treatment of B-cell
malignancies and the ability to accelerate the development of Kite's
pipeline candidates such as KITE-585 into the clinic later this year.
Various factors may cause differences between Kite's expectations and
actual results as discussed in greater detail in Kite's filings with the
2 NCCN and Rajkumar and Kumar,
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