KTE-C19 is an investigational immunotherapy 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. Atezolizumab is an investigational monoclonal antibody designed to target and bind to a protein called PD-L1, which is expressed on tumor cells and tumor-infiltrating immune cells. PD-L1 interacts with PD-1 and B7.1, both found on the surface of T cells, causing inhibition of T cells. Use of the two compounds in combination could provide a synergistic effect since inhibiting PD-L1 with atezolizumab may enhance and prolong the activity and proliferation of KTE-C19.
“Kite is a pioneer in engineered T cell therapy, and we are excited to collaborate with Genentech, an industry leader with a history of developing transformative therapies for cancer,” said Arie Belldegrun, M.D., FACS, Chairman, President and Chief Executive Officer of Kite. “KTE-C19 is currently in four pivotal studies and early clinical findings have shown a potential for breakthrough efficacy in refractory, aggressive NHL and other B cell malignancies. The scientific rationale for combining KTE-C19 and atezolizumab in refractory, aggressive NHL is compelling, and could potentially lead to opportunities to advance this combination in other indications.”
A multi-center Phase 1b/2 study is expected to begin in 2016. The study will use the same KTE-C19 dose and regimen as Kite’s ongoing, potential registration study (ZUMA-1) in patients with refractory, aggressive NHL. Kite will be the sponsor of the study, and the results will be used to evaluate options for further development of the combination.
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 (FDA) has granted Breakthrough Therapy Designation status to KTE-C19, for the treatment of patients with refractory diffuse large B cell lymphoma (DLBCL), primary mediastinal B cell lymphoma (PMBCL), and transformed follicular lymphoma (TFL). 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 for KTE-C19
|Phase 2 Pivotal
|Refractory DLBCL, PMBCL, TFL||Phase 2 enrolling|
|Phase 2 Pivotal
|Relapsed/refractory MCL||Phase 2 enrolling|
|Phase 1/2 Pivotal
|Relapsed/refractory Adult ALL||Phase 1/2 enrolling|
|Phase 1/2 Pivotal
|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, Inc.
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 visitwww.kitepharma.com. Sign up to follow @KitePharma on Twitter athttp://www.twitter.com/kitepharma.
Kite Pharma, Inc. 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 timing of initiating the Phase 1b/2 combination study and expectations regarding the clinical effectiveness and safety of the combination therapy. 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-K for the year ended December 31, 2015. 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.