Directed Against a Validated TCR Target in Solid Tumors
Built on the National Cancer Institute Proof of Concept Work and
Optimized to Include Next Generation T-cell Manufacturing Technologies
SANTA MONICA, Calif.--(BUSINESS WIRE)--
Kite Pharma, Inc. (Nasdaq:KITE)
today announced that it has submitted an Investigational New Drug (IND)
application with the U.S. Food and Drug Administration (FDA) to initiate
a Phase 1 trial of KITE-718, a T cell therapy engineered to express T
cell receptors (TCRs) that target MAGE A3 and MAGE A6. MAGE A3/A6 are
frequently found in common tumors including bladder, esophageal, head
and neck, lung and ovarian cancers. KITE-718 recognizes the MAGE A3 and
MAGE A6 fragments bound to a Class II HLA (DPB1*04:01) and therefore has
the potential to kill tumor cells both directly and indirectly through
activation of the immune system given it incorporates a class II TCR.
Class II HLA (DPB1*04:01) is found in 50 percent to 70 percent of
Caucasians. The trial is designed to assess the safety and anti-tumor
effect of KITE-718 on these solid tumors.
"Submission of this IND is an important milestone for our solid tumor
strategy utilizing engineered T cell therapy based on both TCR and CAR
platform technology," said David Chang, M.D., Ph.D., Executive Vice
President of Research and Development and Chief Medical Officer of Kite.
"TCRs have the potential to access a broad spectrum of tumor targets and
we have incorporated our next generation cell manufacturing technologies
into KITE-718 to exploit targets naturally expressed in common solid
tumors for which there is a great unmet medical need."
KITE-718 is built on the proof of concept data established by the
National Cancer Institute's (NCI) MAGE A3/A6 TCR program (NCT02111850).
No off-target toxicity was observed in the NCI study, and evidence of
tumor regression was seen in patients with multiple types of solid
tumors. KITE-718 has been optimized from the foundational work at the
NCI by streamlining the manufacturing process through advanced
technologies and next-generation cell manufacturing conditions.
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 http://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. 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 ability to
advance and the success of KITE-718 directed against MAGE A3/A6
antigens. 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, 2016.
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
View source version on businesswire.com: http://www.businesswire.com/news/home/20170103005437/en/
SVP, Corporate Communications &
VP, Investor Relations
Source: Kite Pharma, Inc.
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