- TCR product candidate targeting human papillomavirus (HPV)-16 E6 selectively kills cervical and head and neck cancer cells
- Phase 1/2 clinical trial of the HPV-16 E6 TCR is enrolling patients at the National Cancer Institute
SANTA MONICA, Calif., Oct. 1, 2015 (GLOBE NEWSWIRE) -- Kite Pharma, Inc., (NASDAQ:KITE), a clinical-stage biopharmaceutical company focused on developing engineered autologous cell therapy (eACT™) products for the treatment of cancer, today announced the publication of non-clinical findings describing the discovery and characterization of a novel T cell receptor (TCR) product candidate targeting HPV-16 E6. The findings published online by Clinical Cancer Research (a publication of the American Association for Cancer Research), doi:10.1158/1078-0432.CCR-14-3341, show that this TCR is highly selective and has high affinity for the HPV-16 E6, an oncoprotein that is associated with the majority of HPV-mediated cancers. The study also showed T cells engineered with HPV-16 E6 TCR selectively destroyed HPV-16 positive tumor cells. The National Cancer Institute (NCI) is conducting a Phase 1/2 clinical trial of this TCR product candidate under a Cooperative Research and Development Agreement (CRADA) between Kite and the NCI.
"HPV-16 E6 is a viral oncogene that is causally associated with cervical and other HPV-related cancers. Because E6 protein is expressed in cancer cells and absent in normal, healthy tissues, a TCR product candidate with high selectivity for this oncogene has the potential to become a novel cellular therapy directed against HPV-16 positive cancers," commented David Chang, M.D., Ph.D., Executive Vice President R&D and Chief Medical Officer. Dr. Chang added, "Kite is encouraged by the results of this important research, which has formed the basis for translating this novel approach to the clinic."
"HPV infection, responsible for diverse urogenital cancers and the fastest-growing type of cancers of the head and neck, represents an area of compelling unmet medical needs for patients," stated Arie Belldegrun, M.D., FACS, Kite's President and Chief Executive Officer. "Peer-reviewed publications, such as in AACR's Clinical Cancer Research, continue to add significant validation for our broad, advancing pipeline of candidates to treat patients with solid tumors."
In December 2014, Kite signed an exclusive, worldwide license with the National Institutes of Health (NIH) for the rights to develop and commercialize intellectual property related to TCR-based product candidates directed against HPV-16 E6 and E7 oncoproteins for the treatment of HPV-related cancers. Kite expects to file an IND for a Company-sponsored clinical trial of HPV-16 E6 TCR product candidate in the first half of 2016.
About HPV-Associated Cancers
There were over 500,000 new cases of and 275,000 deaths attributable to cervical cancer worldwide in 2008.1 Human papillomavirus (HPV) is the most common viral infection of the reproductive tract, and HPV-16 is believed to cause about 50-60% of cervical cancers. HPV-16 is also implicated in additional urogenital and head and neck cancer types,2 and is believed to cause 90% of HPV-mediated oropharyngeal cancers and the majority of HPV-mediated anal, penile, vaginal and vulvar cancers.
About TCR-based Immunotherapy
Kite's broadly enabling eACT™ technology platform allows a patient's T cells to be genetically modified to express cancer-targeting receptors, including 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 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.
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: the success of the NCI's ongoing HPV TCR product candidate clinical trial and obtaining results from the trial, and the ability and timing of filing a Kite IND on a HPV TCR product candidate. 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 June 30, 2015. 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.
1 CDC: Manual for the Surveillance of Vaccine-Preventable Diseases, Chapter 5: Human Papillomavirus (HPV), accessed 12/16/14.
2 World Health Organization, Human papillomavirus (HPV) and cervical cancer, Fact sheet N°380, accessed 12/16/14.