Kite Pharma, Inc. (KITE) today announced that it has entered into a new Cooperative Research and Development Agreement (CRADA) with the Experimental Transplantation and Immunology Branch (ETIB) of the National Cancer Institute (NCI) for the research and clinical development of T-cell receptor (TCR) product candidates directed against human papillomavirus (HPV)-16 E6 and E7 oncoproteins for the treatment of HPV-associated cancers.
Under the CRADA, NCI will evaluate a novel TCR therapy candidate targeting HPV-16 E7 as a monotherapy and in combination with a checkpoint inhibitor in HPV-16 associated solid tumors. This Phase 1/2 clinical study will be led by Christian S. Hinrichs, M.D., from the ETIB and lead investigator of this CRADA. The NCI will also continue to advance a separately designed TCR therapy candidate targeting HPV-16 E6, currently in a Phase 1/2 clinical trial, under an existing CRADA between Kite and the Surgery Branch of the NCI, led by Steven A. Rosenberg, M.D., Ph.D.
“TCR therapies allow targeting of viral oncoproteins that are not effectively addressed with other existing therapeutic modalities. HPV-16 E6 and E7 TCR therapies hold the potential to address the significant unmet medical need that exists in HPV-associated cancers,” said Arie Belldegrun, M.D., FACS, Kite’s Chairman, President, and Chief Executive Officer. “We are excited to collaborate with the network of talented investigators at the NCI as we advance our HPV-associated cancer therapy pipeline.”
About HPV-Associated Cancers
Human papillomavirus (HPV) has a causal role in nearly all cervical cancers, and in many head and neck, and anogenital malignancies. HPV-16 is the most commonly found strain in these cancers. More than 33,000 cases of HPV-associated cancers are diagnosed each year in the US, and more than 11,000 annual deaths are attributed to the diseases, according to the Centers for Disease Control and Prevention. Current therapies for advanced HPV-associated tumors have low response rates and poor response duration.
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. 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 potential of TCR cell therapy for HPV-associated cancers, the ability to begin a Phase 1/2 clinical study 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 Quarterly Report on Form 10-Q filed with the SEC on May 9, 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.