U.S. Patent Office to Confirm Kite’s Seminal Eshhar CAR-T Patent
June 28 2017 - 8:30AM
Business Wire
Kite Pharma, Inc., (Nasdaq:KITE), a leading cell therapy
company, today announced that the United States Patent and
Trademark Office (USPTO) has provided a Notice of Intent to issue
an Ex Parte Reexamination Certificate that confirms the
patentability of amended claims presented in U.S. Patent No.
7,741,465, known as the Eshhar ‘465 patent. The Eshhar ‘465 patent,
exclusively licensed by Kite in 2013, protects the axicabtagene
ciloleucel franchise and may impact competitive CAR-T
therapies.
“This notice by the USPTO outlining its intent to confirm the
Eshhar patent further asserts the pioneering role of Dr. Zelig
Eshhar in developing CAR-T technology,” said Arie Belldegrun, MD,
FACS, Chairman, President and Chief Executive Officer of Kite. “Our
significant patent portfolio, combined with our positive data and
industry-leading manufacturing process, reinforces our position as
one of the foremost companies in cell therapy.”
The Eshhar ‘465 patent term continues to June 2027, not
including certain potential extensions. Kite’s growing intellectual
property portfolio now encompasses more than 200 patent assets
relating to its broad cell therapy pipeline and manufacturing
excellence.
Axicabtagene ciloleucel is the first engineered cell therapy to
be reviewed by the U.S. Food and Drug Administration (FDA) in
aggressive non-Hodgkin’s lymphoma (NHL). The FDA has set a
Prescription Drug User Fee Act (PDUFA) target action date of
November 29, 2017.
About axicabtagene ciloleucel
Kite's lead product candidate, axicabtagene ciloleucel, is an
investigational therapy in which a patient's T cells are engineered
to express a chimeric antigen receptor (CAR) to target the antigen
CD19, a protein expressed on the cell surface of B-cell lymphomas
and leukemias, and redirect the T cells to kill cancer cells.
Axicabtagene ciloleucel has been granted Breakthrough Therapy
Designation status for diffuse large B-cell lymphoma (DLBCL),
transformed follicular lymphoma (TFL), and primary mediastinal
B-cell lymphoma (PMBCL) by the U.S. Food and Drug Administration
(FDA) and Priority Medicines (PRIME) regulatory support for DLBCL
in the EU.
About Kite
Kite is a biopharmaceutical company engaged in the development
of innovative cancer immunotherapies with a goal of providing
rapid, long-term durable response and eliminating the burden of
chronic care. The company is focused on chimeric antigen receptor
(CAR) and T cell receptor (TCR) engineered cell therapies designed
to empower the immune system's ability to recognize and kill
tumors. Kite is based in Santa Monica, CA. For more
information on Kite, 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. 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: Kite's ability to enforce its patents and
Kite's expectations regarding its ability to obtain and maintain
intellectual property protection for its product candidates, and
the timing and ability of obtaining regulatory approval and
commercially launching axicabtagene ciloleucel. 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 March 31, 2017. 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.
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version on businesswire.com: http://www.businesswire.com/news/home/20170628005430/en/
Kite Pharma, Inc.Christine CassianoSVP, Corporate Communications
& Investor Relationsccassiano@kitepharma.comorGreg MannVP,
Investor Relationsgmann@kitepharma.com
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