Kite Pharma Announces Review of National Cancer Institute’s Manufacturing Facilities

- Kite’s four ongoing multi-center clinical trials of its lead product candidate, KTE-C19, are continuing -

- Kite remains on track to file an investigational new drug application (IND) with the Food and Drug Administration (FDA) by the end of this year for a T cell receptor (TCR)-based product candidate targeting a MAGE antigen for the treatment of certain solid tumors -

SANTA MONICA, Calif., April 16, 2016 -- Kite Pharma, Inc., (Nasdaq:KITE) ("Kite") a clinical-stage biopharmaceutical company focused on developing engineered autologous T cell therapy (eACT™) products for the treatment of cancer, today announced that the cell therapy manufacturing facilities at the National Cancer Institute (NCI) are undergoing a voluntary internal review by the National Institutes of Health (NIH) in connection with the NIH’s review of all NCI facilities involving sterile material. 

Kite and the NCI are advancing multiple clinical trials under Cooperative Research and Development Agreements (CRADAs) for the treatment of both hematological and solid tumors.  Patients currently enrolled in the ongoing NCI clinical trials will receive therapy, but no new patients will be enrolled until the review is complete.  The NCI’s ongoing clinical trial of a fully human anti-CD19 chimeric antigen receptor (CAR)-based product candidate is not affected by the review.  

The review of the NCI’s manufacturing facilities is not related to KTE-C19 or Kite’s manufacturing capabilities.  Kite’s four ongoing multi-center clinical trials of KTE-C19 are continuing.  Kite also remains on track to file an IND with the FDA by the end of this year for a TCR-based product candidate targeting a MAGE antigen for the treatment of certain solid tumors. 

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 ability and timing of filing an IND for a TCR-based product candidate, and the ability and willingness of the NCI to continue research and development activities pursuant to the CRADAs. 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 Kite's Annual Report on Form 10-K filed with the SEC on February 29, 2016. 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: Greg Mann         
VP, Investor Relations
[email protected]
         
For Media: Justin Jackson         
Burns McClellan
(212) 213-0006
[email protected]