December 19, 2016
Kite Pharma Announces Successful Defense of Roberts Patent and Intent to Appeal U.S. Patent and Trademark Office Decision on a Narrow Patent Focused on Select CD28 CAR-T Products
- Kite to Appeal USPTO Declining to Revoke Narrow Patent Against Certain CAR-T Constructs having a Single Specified CD28 Sequence
- Kite Successfully Defeats 3rd Party Challenge to Kite CAR-T Patent which Covers Methods for Using Modified T cells Containing scFv Binding Elements and Other Key CAR-T Features
SANTA MONICA, Calif.--(BUSINESS WIRE)-- Kite Pharma, Inc. (Nasdaq:KITE) today announced several updates to its broad intellectual property portfolio relating to the use of chimeric antigen receptors (CARs) to harness the power of a patient's immune cells. These updates include a recent U.S. Patent and Trademark Office (USPTO) decision concerning one narrow patent related to CAR products containing a pre-specified CD28 costimulatory domain, and a recent favorable result in a challenge at the USPTO to one of Kite's important CAR-T patents, U.S. Patent Number 6,319,494.
In August 2015, Kite preemptively filed a petition with the U.S. Patent and Trademark Office (USPTO) to institute an inter partes review (IPR) of U.S. Patent No. 7,446,190 owned by Sloan Kettering Institute for Cancer Research and licensed by Juno Therapeutics, Inc. The IPR was aimed at invalidating the ‘190 patent, which has a narrow scope directed to CAR products containing a pre-specified CD28 costimulatory domain. The USPTO's recent ruling in this matter did not revoke the patent. However, Kite continues to believe the patent to be invalid and plans to appeal the USPTO decision to the U.S. Court of Appeals for the Federal Circuit. This patent does not have any counterpart patents outside of the United States.
The USPTO's decision will have no impact on the timing of the rolling submission or review of the Biologics License Application for Kite's lead product candidate, axicabtagene ciloleucel (KTE-C19), a potentially lifesaving investigational therapy that has demonstrated the most advanced utilization of the CD28 costimulatory domain in a CAR-T therapy to date. Axicabtagene ciloleucel is currently being developed for the treatment of CD19 positive B cell malignancies, including non-Hodgkin lymphoma and acute lymphoblastic leukemia.
Separately, Kite recently defeated an anonymous challenge filed against U.S. Patent Number 6,319,494, developed by Kite's Senior Vice President of Discovery Research, Margo Roberts, Ph.D. and colleagues. This patent, which covers methods for treating a viral disease or malignancy using modified T cells that contain single-chain variable fragment (scFv) binding elements and other key CAR-T features, impacts multiple competitor CAR-T cell product candidates under development.
In addition to the Roberts patent, Kite's growing intellectual property portfolio encompasses more than 150 patent assets including an exclusive license to U.S. Patent No. 7,741,465, a leading and widely significant patent directed to CAR-T constructs, developed by Dr. Zelig Eshhar and colleagues. This patent, currently under reexam by the USPTO, potentially impacts CAR-T products under development by multiple Kite competitors.
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. 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 successfully appeal the USPTO decision not to revoke the ‘190 patent, 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. 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 release.
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SVP, Corporate Communications & Investor Relations
VP, Investor Relations
Source: Kite Pharma, Inc.
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