SANTA MONICA, Calif., Dec. 7, 2015 (GLOBE NEWSWIRE) -- Kite Pharma, Inc. (Nasdaq: KITE ) today announced clinical biomarker data and product characteristics for anti-CD19 chimeric antigen receptor (CAR) T cell therapy in patients with relapsed/refractory non-Hodgkin lymphoma (NHL) enrolled in an ongoing phase 1-2 clinical trial at the National Cancer Institute (NCI), which is being conducted under a Cooperative Research and Development Agreement (CRADA) between Kite and the NCI. In this clinical trial, patients with a range of B cell cancers were conditioned with cyclophosphamide and fludarabine prior to receiving anti-CD19 CAR T cell therapy.
Two posters were presented at the ASH meeting from the NCI trial:
"Pharmacodynamic Profile and Clinical Response in Patients with B-Cell Malignancies of Anti-CD19 CAR T-Cell Therapy." Abstract #2042; Presenter: Dr. Adrian Bot, Kite Pharma; Saturday, December 5, 2015: 5:30 - 7:30 PM Eastern.
This study analyzed the product characteristics and biological activity of the anti-CD19 CAR T cells and concluded that anti-CD19 CAR T cells are polyfunctional, capable of producing a broad range of immune modulating cytokines, chemokines and effector molecules that peak sequentially.
This analysis included 17 patients treated with a low dose conditioning chemotherapy regimen (cyclophosphamide 300-500 mg/m 2 /day and fludarabine 30 mg/m 2 /day for 3 days) of which 10 received anti-CD19 CAR T cells that were manufactured under a new process, which was co-developed with Kite. The objective response rate was 71% (35% complete remission (CR)) overall and 70% (40% CR) among those treated with cells manufactured using the new process. Grade 3 or 4 cytokine release syndrome or neurotoxicity was observed in 59% of patients and was generally reversible.
"Cyclophosphamide and Fludarabine Conditioning Chemotherapy Induces a Key Homeostatic Cytokine Profile in Patients Prior to CAR T Cell Therapy." Abstract #4426; Presenter: Dr. Adrian Bot, Kite Pharma; Monday, December 7, 2015: 6:00 - 8:00 PM Eastern.
The clinical researchers found that the conditioning regimen of cyclophosphamide and fludarabine triggered changes in several key cytokines and chemokines that could drive expansion, activation, and trafficking of CAR T cells. Preliminary results suggest that the magnitudes of rise in interleukin-15 and reduction in perforin are associated with objective responses.
David Chang, M.D., Ph.D., Kite's Executive Vice President, Research and Development, and Chief Medical Officer, commented, "The results being reported at ASH provide meaningful insight into the importance of an optimized conditioning chemotherapy regimen, as well as the impact of the manufacturing approach on the effect of CAR T cell therapy. These findings have guided the design of Kite's ongoing program for KTE-C19 (anti-CD19 CAR T cell therapy), which is currently enrolling patients in multiple clinical trials to support product registration."
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 continued progress and success of the NCI's clinical trials under the CRADA between Kite Pharma and the NCI. 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.
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
