Kite Pharma Announces Key Presentations on KTE-C19 and

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News Desk 2018
Kite Pharma Announces Key Presentations on KTE-C19 and Engineered Cell Therapy Pipeline Programs at the Annual Meeting of the American Association for Cancer Research (AACR)

SANTA MONICA, Calif., April 15, 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 the schedule of presentations and addresses related to its engineered cell therapy programs at the upcoming AACR Annual Meeting in New Orleans, Louisiana. Topics will include KTE-C19, Kite's lead chimeric antigen receptor (CAR) product candidate, as well as engineered T cell receptor (TCR) product candidates targeting solid tumors that express the MAGE-A3 and KRAS cancer proteins. KTE-C19 is currently being studied in four pivotal clinical trials. Clinical study of the MAGE-A3 TCR and pre-clinical study of KRAS TCRs are being advanced as part of a Cooperative Research and Development Agreement (CRADA) between Kite and the National Cancer Institute.

Oral Presentations

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: April 19, 2016, 4:00 - 4:15PM 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

A Phase 1 Study of an HLA-DPB1*0401-restricted T Cell Receptor Targeting MAGE-A3 for Patients with Metastatic Cancer Date:   April 17, 2016, 3:15 - 3:35PM Central Time Session:  Immuno-Oncology Clinical Trials I Abstract Number:  CT003 Location:  La Nouvelle Orleans Ballroom, Morial Convention Center Presenter:  Yong-Chen W. Lu, Ph.D., Surgery Branch, National Cancer Institute

Session Presentations

Plenary Session: T Cell Recognition of Human Cancer Date: April 17, 2016, 11:00 - 11:30AM Central Time Session: PL01 Opening Plenary - Breakthroughs in Cancer Research: Genomics, Epigenetics, and Immunomodulation Location: Hall F, Morial Convention Center Speaker: Ton Schumacher, Ph.D., Netherlands Cancer Institute

Targeting Cancers with Engineered T Cells or BiTES: Towards Broader Application Date: April 18, 2016, 5:00 - 6:30PM Central Time Session: Forum FO09 Location: La Nouvelle Orleans Ballroom, Morial Convention Center Invited Speaker: David Chang, M.D., Ph.D., Kite Pharma

Poster Presentations

Manufacturing and Characterization of KTE-C19 in a Multicenter Trial of Subjects with Refractory Aggressive Non-Hodgkin's Lymphoma (NHL) (ZUMA-1) Date:  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:  John M. Rossi, Kite Pharma

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:  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

Identification of T-cell Receptors Targeting KRAS-mutated Human Tumors Date: April 19, 2016, 8:00AM - 12:00PM Central Time Session: Late-Breaking Research: Experimental and Molecular Therapeutics 3 Abstract Number: LB-242 Location: Poster Hall, Section 11, Poster Board 22 Presenters: James C. Yang, M.D., National Cancer Institute, National Institutes of Health

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

 
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 National Cancer Institute to continue research and development activities relating to technologies 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 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.

 

CONTACT: Greg Mann         VP, Investor Relations gmann@kitepharma.com          For Media: Justin Jackson         Burns McClellan (212) 213-0006 jjackson@burnsmc.com

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