SANTA MONICA, Calif.--(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.
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.