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Press Release

Kite Pharma to Present KTE-C19 Data from Interim Analysis of the ZUMA-1 Pivotal Trial in Patients with Chemorefractory Primary Mediastinal B-Cell Lymphoma (PMBCL) and Transformed Follicular Lymphoma (TFL) at the 2016 American Society Hematology Annual Meeting

Kite Pharma,Inc.
Posted on: 03 Nov 16

Kite Pharma, Inc. (Nasdaq:KITE) today announced that new data will be presented from multiple studies related to its lead investigational candidate, KTE-C19, at the American Society of Hematology (ASH) 58th Annual Meeting in San Diego, CA, December 3-6, 2016.

“In the last year alone, Kite has made significant advancements in our efforts to transform the treatment of cancer and deliver the first, and potentially transformative, personalized CAR-T cell therapy,” said David Chang, M.D., Ph.D., Executive Vice President, Research and Development, and Chief Medical Officer of Kite. “At this year’s ASH meeting, we will show additional detail from the interim analysis from ZUMA-1 as well as new KTE-C19 data and reproducibility in our manufacturing process from our ZUMA-3 and ZUMA-4 trials. The additional data sets continue to provide deeper insights into the therapy’s potential to transform the treatment of B-cell malignancies.”

Oral Presentations

A Phase 2 Multicenter Trial of KTE-C19 (anti-CD19 CAR T Cells) in Patients with Chemorefractory Primary Mediastinal B-Cell Lymphoma (PMBCL) and Transformed Follicular Lymphoma (TFL): Interim Results From ZUMA-1

This oral presentation will feature initial results from Cohort 2 of the pivotal ZUMA-1 Phase 2 trial. Cohort 2 focuses on patients with chemorefractory PMBCL and TFL, both forms of aggressive non-Hodgkin lymphoma (NHL). In September 2016, Kite announced interim positive topline results from ZUMA-1 in both Cohort 1 (chemorefractory diffuse large B-cell lymphoma (DLBCL)) and Cohort 2.

Production of Anti-CD19 CAR T Cells for ZUMA-3 and -4: Phase 1/2 Multicenter Studies Evaluating KTE-C19 in Patients with Relapsed/Refractory B-Precursor Acute Lymphoblastic Leukemia (R/R ALL)

This presentation will describe the robust and reliable manufacturing process utilized in the multicenter ZUMA-3 and -4 studies for the production of KTE-C19 for patients with R/R ALL.

T cells Expressing a Novel Fully-human Anti-CD19 Chimeric Antigen Receptor Induce Remissions of Advanced Lymphoma in a First-in-humans Clinical Trial

This presentation will review a Phase 1 dose-escalation trial conducted to investigate the safety and efficacy of engineered T cells with a fully-human anti-CD19 chimeric antigen receptor for the treatment of advanced lymphoma. This investigational therapy is being evaluated pursuant to Kite’s Cooperative Research and Development Agreement with the NCI.

Poster Presentation

High Rates of Minimal Residual Disease-Negative (MRD−) Complete Responses (CR) in Adult and Pediatric and Patients with Relapsed/Refractory Acute Lymphoblastic Leukemia (R/R ALL) Treated With KTE-C19 (Anti-CD19 Chimeric Antigen Receptor [CAR] T Cells): Preliminary Results of the ZUMA-3 and ZUMA-4 Trials

This poster will review the preliminary safety and efficacy data from the Phase 1 portion of ZUMA-3 and ZUMA-4 trials of KTE-C19 in adult and pediatric patients with R/R ALL.

About KTE-C19

Kite Pharma's lead product candidate, KTE-C19, is an investigational therapy in which a patient's T cells are engineered to express a 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. KTE-C19 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 Pharma

Kite Pharma, Inc. is a clinical-stage biopharmaceutical company engaged in the development of novel cancer immunotherapy products, with a primary focus on engineered autologous cell therapy (eACT™) designed to restore the immune system's ability to recognize and eradicate tumors. Kite is based in Santa Monica, CA. For more information on Kite Pharma, 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 progress and success of the ZUMA clinical program. Various factors may cause differences between Kite's expectations and actual results as discussed in greater detail in Kite's filings with the Securities and Exchange Commission, including without limitation in its Form 10-Q for the quarter ended June 30, 2016. Any forward-looking statements that are made in this press release speak only as of the date of this press release. Kite assumes no obligation to update the forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.

View source version on businesswire.com: http://www.businesswire.com/news/home/20161103005966/en/

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Last updated on: 03/11/2016

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