On March 20, 2017 Kite Pharma, Inc. (Nasdaq:KITE) reported new data presentations from multiple studies related to its lead investigational candidate, axicabtagene ciloleucel, at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in Washington D.C., April 1-5, 2017 (Press release, Kite Pharma, MAR 30, 2017, View Source [SID1234518324]). Kite will also present pre-clinical data relating to KITE-585, the company’s fully human anti-B cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T-cell product candidate. The full text for clinical trial abstracts will be available online March 31, 2017, at 4:30 p.m. Eastern Time, through the AACR (Free AACR Whitepaper) website at www.aacr.org. Schedule your 30 min Free 1stOncology Demo! "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 David Chang, M.D., Ph.D., Executive Vice President, Research and Development, and Chief Medical Officer. "We intend to apply the learnings from ZUMA-1, as well as our internal clinical development and manufacturing expertise, to accelerate the development of some of our most promising pipeline candidates such as KITE-585 into the clinic later this year."
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Oral Presentations
Primary results from ZUMA-1: a pivotal trial of axicabtagene ciloleucel (axicel; KTE-C19) in patients with refractory aggressive non-Hodgkin lymphoma (NHL)
Abstract # CT019
Presenter: Frederick L. Locke, M.D., Moffitt Cancer Center, Tampa, FL
Session: Immuno-oncology Biomarkers in Clinical Trials Plenary Session
Sunday, April 2, 2017: 4:05-4:14 PM EDT; Hall D-E, Level 2
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)
Abstract # CT020
Presenter: Frederick L. Locke, M.D., Moffitt Cancer Center, Tampa, FL
Session: Immuno-oncology Biomarkers in Clinical Trials Plenary Session
Sunday, April 2, 2017: 4:14-4:24 PM EDT; Hall D-E, Level 2
Polyfunctional anti-CD19 CAR T cells determined by single-cell multiplex proteomics associated with clinical activity in patients with advanced non-Hodgkin’s lymphoma
Abstract # 2990
Presenter: John M. Rossi, M.S., Kite Pharma
Session: Clinical Research, Clinical Biomarkers
Monday, April 3, 2017: 4:05-4:20 PM EDT; Room 151, Level 1
Development of KITE-585: A fully human BCMA CAR T-cell therapy for the treatment of multiple myeloma
Abstract # 4979
Presenter: Gregor B. Adams, Ph.D., Kite Pharma
Session: Immunology: Adoptive Cellular Therapy for Cancer
Tuesday, April 4, 2017: 3:35-3:50 PM EDT; Ballroom A-B, Level 3
Poster Presentations
Selectivity and specificity of engineered T cells expressing KITE-585, a chimeric antigen receptor targeting B-cell maturation antigen (BCMA)
Abstract # 2135
Presenter: Tassja Spindler, Kite Pharma
Session: Experimental and Molecular therapeutics: New Targets 2
Monday, April 3, 2017: 1:00-5:00 PM EDT; Halls A-C, Poster Section 6
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.
About KITE-585
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.