January 07, 2015
Kite Pharma Announces Exclusive License With the National Institutes of Health for T Cell Receptor (TCR)-Based Products to Treat HPV-Associated Cancers
SANTA MONICA, Calif., Jan. 7, 2015 (GLOBE NEWSWIRE) -- Kite Pharma, Inc. (Nasdaq: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 Company has entered into an exclusive, worldwide license with the National Institutes of Health (NIH) for intellectual property related to T Cell Receptor (TCR)-based product candidates directed against human papillomavirus (HPV)-16 E6 and E7 oncoproteins for the treatment of cancers associated with HPV infection. The National Cancer Institute (NCI) has recently initiated a Phase 1/2 clinical trial of one of these TCR product candidates, targeting the HPV-16 E6 oncoprotein, under a Cooperative Research and Development Agreement (CRADA) between Kite and the NCI. Pursuant to the terms of the license agreement, Kite will make to NIH certain clinical, regulatory, and sales milestone payments and royalties on net sales of products covered by the license.
"This agreement with NIH further extends our growing therapeutic pipeline, allowing us to enter an area of medicine with extensive and growing unmet needs worldwide," stated Arie Belldegrun, M.D., FACS, Kite Pharma's president and chief executive officer. "We believe that our TCR technology holds great promise to improve outcomes for patients with solid tumors, such as cervical cancer and head and neck cancer, and we are pleased to announce this license with NIH."
About HPV-Associated Cancers
Human papillomavirus (HPV) is the most common viral infection of the reproductive tract, with two viral strains - HPV-16 and HPV-18 - believed to cause 70% of cervical cancers and precancerous cervical lesions, as well as other urogenital cancers.1
There were over 500,000 new cases of and 275,000 deaths attributable to cervical cancer worldwide in 2008.2 Additionally, HPV infection is causally associated with oral and oropharyngeal squamous cell carcinomas (OSCC). Estimates by the Centers for Disease Control and Prevention attribute 9,000 new cases of oropharyngeal cancers in the U.S. each year to HPV infection, nearly three-quarters of all new cases.3 In the European Union, more than half of OSCC patients are estimated to have tumor tissue infected with HPV.4
About TCR-based Immunotherapy
Kite Pharma's broadly enabling eACT™ technology platform allows a patient's T cells to be genetically modified to express cancer-targeting receptors, including T cell receptors (TCRs). Engineered TCR T cells express alpha and beta chains of the T cell receptor, which recognize and bind to MHC-presented tumor antigens. Once modified, the T cells can traffic directly to tumor sites and become activated upon engagement with the target tumor antigen, selectively eradicating the tumor cells.
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 eACT™ designed to restore the immune system's ability to recognize and eradicate tumors. In partnership with the NCI Surgery Branch through a Cooperative Research and Development Agreement (CRADA), Kite is advancing a pipeline of proprietary eACT™ peripheral blood product candidates, both CAR (chimeric antigen receptor) and TCR (T cell receptor) products, directed to a wide range of cancer indications. Kite is based in Santa Monica, CA. For more information on Kite Pharma, please visit www.kitepharma.com.
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 willingness of the NCI to continue research and development activities relating to eACT™ pursuant to the CRADA; our expectations regarding the clinical effectiveness and safety of our product candidates and results of the NCI's clinical trials; the timing of and our ability to obtain and maintain U.S. Food and Drug Administration or other regulatory authority approval of, or other action with respect to, our product candidates; the potential for TCR-based product candidates to safely and effectively treat solid tumors and HPV-related cancers; and our ability to protect our proprietary technology and enforce our intellectual property rights. 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, 2014. 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.
1 World Health Organization, Human papillomavirus (HPV) and cervical cancer, Fact sheet N°380, accessed 12/16/14.
2 CDC: Manual for the Surveillance of Vaccine-Preventable Diseases, Chapter 5: Human Papillomavirus (HPV), accessed 12/16/14.
3 CDC: How Many Cancers Are Linked with HPV Each Year?, accessed 12/26/14.
4 Marur S. et al. HPV-associated head and neck cancer: a virus-related cancer epidemic. Lancet Oncol. 2010;11:781-9 10.1016/S1470-2045(10)70017-6
CONTACT: Kite Contacts:
Cynthia M. Butitta
Chief Financial Officer and Chief Operating Officer
For Media: Justin Jackson
For Investor Inquiries: Nancy YuBurns McClellan
Kite Pharma, Inc.
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