Kite Pharmaceuticals, Inc.
May 31, 2016

Kite Pharma to Highlight Key Data from Engineered CAR T Cell Therapy Pipeline at the 2016 American Society of Clinical Oncology Annual Meeting

SCHOLAR-1, a retrospective meta-analysis of patient outcomes from two observational databases and two Phase 3 studies, highlights unmet medical need in chemorefractory diffuse large B-cell lymphoma

Study of anti-CD19 chimeric antigen receptor (CAR) T cells in advanced lymphoma patients, conducted in partnership with the National Cancer Institute

Updated Phase 1 data from KTE-C19 ZUMA-1 study in chemorefractory aggressive non-Hodgkin lymphoma

SANTA MONICA, Calif.--(BUSINESS WIRE)-- 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 four presentations relating to its clinical programs will be delivered at the upcoming 2016 American Society of Clinical Oncology (ASCO) Annual Meeting.

"Our presence at this year's ASCO reinforces our progress toward delivering a breakthrough personalized cell therapy for patients with refractory hematological malignancies who have limited or no treatment options," said Arie Belldegrun, M.D., FACS, Chairman, President, and Chief Executive Officer of Kite. "These data represent a key milestone in our trajectory to advance personalized T cell immuno-oncology and ultimately address critical unmet medical needs."

Data to be presented include results from Kite's SCHOLAR-1 study, the first and largest meta-analysis of outcomes in patients with chemorefractory diffuse large B-cell lymphoma (DLBCL), an aggressive non-Hodgkin lymphoma (NHL). Patients with chemorefractory DLBCL have not responded to prior treatment with chemotherapy or have relapsed within a year after autologous stem cell transplantation.

Data from a Phase 1-2a study evaluating anti-CD19 CAR T cell therapy after low-dose chemotherapy in people with advanced lymphoma will be presented in a Late-Breaking Abstract oral session by James N. Kochenderfer, M.D., an investigator in the Experimental Transplantation and Immunology Branch of the National Cancer Institute (NCI) Center for Cancer Research. This study is being conducted as part of a Cooperative Research and Development Agreement (CRADA) between Kite and the NCI.

Kite will also provide an update on patients with chemorefractory aggressive NHL from the Phase 1 portion of the ZUMA-1 study and present a poster on the study design of ZUMA-4, an ongoing Phase 1/2 study of KTE-C19 in children and young adults with previously treated acute lymphoblastic leukemia.

Presentations at the 2016 ASCO Annual Meeting:

Oral Presentation

Anti-CD19 chimeric antigen receptor T cells preceded by low-dose chemotherapy to induce remissions of advanced lymphoma

Date: Monday, June 6, 2016, 4:42-4:54 PM CDT
Location: Hall D2
Abstract Number: LBA3010
Presenter: James Kochenderfer, M.D., Experimental Transplantation and Immunology Branch, National Cancer Institute, Bethesda, MD

Poster Discussion

Outcomes in refractory aggressive diffuse large b-cell lymphoma (DLBCL): results from the international SCHOLAR-1 Study

Date: Monday, June 6, 2016, 1:15-2:45 PM CDT
Location: E354b
Abstract Number: 7516
Presenter: Michael Crump, M.D., FRCPC, Princess Margaret Cancer Centre, Toronto, Ontario, Canada

Poster Presentations

Ongoing complete remissions (CR) in the phase 1 of ZUMA-1: a phase 1-2 multicenter study evaluating the safety and efficacy of KTE-C19 (anti-CD19 CAR T cells) in subjects with refractory aggressive B-cell Non-Hodgkin Lymphoma (NHL)

Date: Monday, June 6, 2016, 8:00-11:30 AM CDT
Location: Poster Board 115, Hall A
Abstract Number: 7559
Presenter: Sattva Swarup Neelapu, M.D., The University of Texas MD Anderson Cancer Center, Houston, TX

ZUMA-4: A phase 1/2 multicenter study evaluating the safety and efficacy of KTE-C19 (anti-CD19 CAR T cells) in pediatric and adolescent subjects with relapsed/refractory B-precursor acute lymphoblastic leukemia (r/r ALL)

Date: Monday, June 6, 2016, 8:00-11:30 AM CDT
Location: Poster Board 65a, Hall A
Abstract Number: TPS7075
Presenter: Alan S. Wayne, M.D., Children's Hospital Los Angeles, Los Angeles, 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 Kite's ZUMA Clinical Programs for KTE-C19

KTE-C19 is an investigational therapy in which a patient's T cells are genetically modified to express a CAR that is 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 FDA 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 Designations in the U.S. and the EU for diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma, mantle cell lymphoma, acute lymphoblastic leukemia, and chronic lymphocytic leukemia.

 
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

NCT02625480

  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
 

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 the ability and willingness of the NCI to continue research and development activities pursuant to the CRADA. 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 Quarterly Report on Form 10-Q filed with the SEC on May 9, 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.

Kite Pharma
Greg Mann
VP, Investor Relations
gmann@kitepharma.com
or
For Media:
inVentiv Health
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Source: Kite Pharma, Inc.

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