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.
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/m2/day and fludarabine 30 mg/m2/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.
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.
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Kite Pharma Cynthia M. ButittaChief Financial Officer and Chief Operating Officer 310-824-9999 For Media: Justin JacksonFor Investor Inquiries: Lisa Burns Burns McClellan212-213-0006 email@example.com firstname.lastname@example.org
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