Kite Pharmaceuticals, Inc.
Dec 7, 2015

Kite Pharma Initiates the ZUMA-4 Study to Support Registration of KTE-C19 for Relapsed or Refractory (r/r) Acute Lymphoblastic Leukemia (ALL) in Children and Young Adults

SANTA MONICA, Calif., Dec. 7, 2015 (GLOBE NEWSWIRE) -- Kite Pharma, Inc. (Nasdaq:KITE) today announced that it has initiated a phase 1/2 clinical study of KTE-C19 (ZUMA-4) for the treatment of pediatric and young adult patients with r/r ALL. KTE-C19 is an investigational therapy in which a patient's T cells are genetically modified to express a chimeric antigen receptor designed to target the antigen CD19, a protein expressed on the cell surface of B cell lymphomas and leukemias.

"With the commencement of ZUMA-4, Kite has achieved its goal of initiating four company-sponsored trials this year for its lead product candidate, KTE-C19," said David Chang, M.D., Ph.D., Kite's Executive Vice President, Research and Development, and Chief Medical Officer. "Our ZUMA trials are investigating critical needs in non-Hodgkin lymphoma (NHL) and ALL in patients with advanced, relapsed or refractory disease who have few or no other treatment options."

"We are enthusiastic about the possibility that KTE-C19 could safely put children and young adults who have persistent ALL despite multiple prior standard therapies into complete remissions," said internationally recognized leukemia expert Leonard S. Sender, M.D., Medical Director and Division Chief, and ZUMA-4 trial investigator, at Children's Hospital of Orange Country. "Kite has done an outstanding job advancing immunotherapy for testing in multiple multi-center trials, and we are thrilled to offer this trial to our young patients and their families."

ZUMA-4 will proceed as a single-arm, open-label, multi-center study in patients with ALL whose disease is refractory to or has relapsed following standard chemotherapy or hematopoietic stem cell transplantation. The phase 1 portion of ZUMA-4 will assess the safety of KTE-C19, and the phase 2 portion will assess efficacy and safety. The study will target to enroll a total of 75 patients. Additional details about this study will be available on ClinicalTrials.gov.

About Kite's ZUMA Clinical Programs

 
Study Phase Indication Status
ZUMA-1
NCT02348216
Phase 2 Pivotal
(N=112)
Refractory DLBCL, PMBCL, TFL Phase 2 enrolling
ZUMA-2
NCT02601313
Phase 2 Pivotal
(N=70)
Relapsed/refractory MCL Phase 2 enrolling
ZUMA-3
NCT02614066
Phase 1/2 Pivotal
(N=75)
Relapsed/refractory Adult ALL Phase 1/2 enrolling
ZUMA-4 Phase 1/2 Pivotal
(N=75)
Relapsed/refractory Pediatric ALL Phase 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

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. 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 and to obtain regulatory approval based on the studies 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 its Form 10-Q for the quarter ended September 30, 2015. 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.

CONTACT: Kite Pharma

         Cynthia M. Butitta

         Chief Financial Officer and Chief Operating Officer

         310-824-9999



         For Media: Justin Jackson

         For Investor Inquiries: Lisa Burns

         Burns McClellan

         212-213-0006

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Source: Kite Pharma, Inc.

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