Kite Pharma Announces Clinical Biomarker Results of Anti-CD19 CAR T Cell Therapy at the 57th American Society of Hematology A...
December 07 2015 - 12:00PM
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/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. 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.
CONTACT: 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
jjackson@burnsmc.com
lburns@burnsmc.com
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