Kite Pharmaceuticals, Inc.
Mar 16, 2016

Kite Pharma Announces Clinical and Manufacturing Updates on KTE-C19 and MAGE-A3 Product Candidates at the Annual Meeting of the American Association for Cancer Research (AACR)

SANTA MONICA, Calif., March 16, 2016 (GLOBE NEWSWIRE) -- Kite Pharma, Inc., (Nasdaq:KITE) ("Kite") a clinical-stage biopharmaceutical company focused on developing engineered autologous T cell therapy (eACT™) products for the treatment of cancer, today announced two oral presentations and two poster presentations to be delivered at the upcoming American Association for Cancer Research (AACR) Annual Meeting in New Orleans, Louisiana. The oral presentations will address KTE-C19, Kite's lead chimeric antigen receptor (CAR) product candidate, and, separately, an engineered T cell receptor (TCR) product candidate targeting the cancer testis antigen MAGE-A3. The TCR product candidate is currently being studied as part of a Cooperative Research and Development Agreement (CRADA) between Kite and the National Cancer Institute.

Oral Presentations:

Title:  Updated Phase 1 Results from ZUMA-1: A Phase 1-2 Multi-Center Study Evaluating the Safety and Efficacy of KTE-C19 (Anti-CD19 CAR T Cells) in Subjects with Refractory Aggressive Non-Hodgkin Lymphoma (NHL)

Date: Tuesday, April 19, 2016 3:00-5:00PM Central Time
Session: Early Clinical Trials Evaluating Cell-based, Checkpoint Inhibitors, and Novel Immunotherapeutics
Abstract Number: CT135
Location: Room 343, Morial Convention Center
Presenter: Armin Ghobadi, M.D., Washington University, St. Louis, MO

Title: A Phase 1 Study of an HLA-DPB1*0401-restricted T Cell Receptor Targeting MAGE-A3 for Patients with Metastatic Cancer

Date:   Sunday, April 17, 2016 2:15-4:00PM Central Time
Session:  Immuno-Oncology Clinical Trials I
Abstract Number:  CT003
Location:  La Nouvelle Ballroom, Morial Convention Center
Presenter:  Yong-Chen W. Lu, Ph.D., Surgery Branch, National Cancer Institute

Poster Presentations:

Title:  Manufacturing and Characterization of KTE-C19 in a Multicenter Trial of Subjects with Refractory Aggressive Non-Hodgkin's Lymphoma (NHL) (ZUMA-1)

Date:  Monday, April 18, 2016 1:00-5:00PM Central Time
Session:   Adoptive Cell Therapy
Abstract Number:   2308
Location:  Poster Hall, Section 25, Poster Board 20
Presenter:  Marc Better, Ph.D., Kite Pharma, Santa Monica, CA

Title:  Comparative Evaluation of Peripheral Blood T cells and Resultant Engineered Anti-CD19 CAR T Cell Products from Relapsed/Refractory Non-Hodgkin's Lymphoma (NHL) Patients

Date:  Monday, April 18, 2016 1:00-5:00PM Central Time
Session:  Adoptive Cell Therapy
Abstract Number:  2305
Location:  Poster Hall, Section 25, Poster Board 17
Presenter:  Timothy J. Langer, Kite Pharma, Santa Monica, CA

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.

About KTE-C19

KTE-C19 is an investigational therapy in which a patient's T cells are genetically modified to express a CAR designed to target the antigen CD19, a protein expressed on the cell surface of B cell lymphomas and leukemias.  Kite is currently enrolling four pivotal studies (also known as ZUMA studies) for KTE-C19 in patients with various B cell malignancies.  The U.S. Food and Drug Administration has granted Breakthrough Therapy Designation status to KTE-C19, for the treatment of patients with refractory diffuse large B cell lymphoma, primary mediastinal B cell lymphoma, and transformed follicular lymphoma. KTE-C19 has also secured Orphan Drug Designation in the U.S. for DLBCL and in the EU for various hematological indications. 

About Kite's ZUMA Clinical Programs

 
StudyPhaseIndicationStatus
ZUMA-1
NCT02348216
Phase 2 Pivotal
(N=112)
Refractory DLBCL, PMBCL, TFLPhase 2 enrolling
ZUMA-2
NCT02601313
Phase 2 Pivotal
(N=70)
Relapsed/refractory MCLPhase 2 enrolling
ZUMA-3
NCT02614066
Phase 1/2 Pivotal
(N=75)
Relapsed/refractory Adult ALLPhase 1/2 enrolling
ZUMA-4
NCT02625480
Phase 1/2 Pivotal
(N=75)
Relapsed/refractory Pediatric ALLPhase 1/2 enrolling
 
DLBCL = diffuse large B cell lymphoma
PMBCL = primary mediastinal B cell lymphoma
TFL = transformed follicular lymphoma
MCL = mantle cell lymphoma
ALL = acute lymphoblastic leukemia


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. We 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 our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: the ability to advance multiple clinical trials of KTE-C19. 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 Kite's Annual Report on Form 10-K filed with the SEC on February 29, 2016. Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.


Greg Mann

VP, Investor Relations

gmann@kitepharma.com



For Media: Justin Jackson

Burns McClellan

(212) 213-0006

jjackson@burnsmc.com

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Source: Kite Pharma, Inc.

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