On October 16, 2012 Kite Pharma reported that it has entered into a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI) for the development and commercialization of novel engineered peripheral blood autologous T cell therapeutics (eACT) for the treatment of multiple cancer indications. The collaboration with the Surgery Branch at NCI, led by Steven A. Rosenberg M.D., Ph.D., provides Kite with exclusive access to the current and future clinical product pipeline of autologous peripheral blood T cells, engineered with the NCI’s proprietary tumor-specific T Cell Receptors (TCRs) and Chimeric Antigen Receptors (CARs), directed to multiple hematological and solid tumor types.

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Clinical evidence has demonstrated that patients’ peripheral blood T cells engineered with TCRs or CARs that recognize tumor specific molecules can traffic directly to the tumor, become activated upon engagement with the tumor antigen, and selectively eradicate tumors. Clinical studies using these types of engineered peripheral blood T cells, performed at NCI, have been associated with highly significant and durable objective clinical responses in cancer patients with advanced metastatic disease, including those with refractory melanoma, sarcoma, lymphoma and leukemia. These encouraging results highlight eACT/TCR/CARs as an emerging therapeutic modality that could provide new personalized targeted therapy options for cancer patients spanning the spectrum of disease from its early stages to the salvage setting.

"We are very pleased to partner with Dr. Rosenberg and his team, whose vision, innovation, and groundbreaking work in the field of cancer immunotherapy was instrumental in the development of autologous cell therapy and realization of its potential for cancer treatment," said Dr. Aya Jakobovits, President and CEO of Kite. "We regard eACT/TCR/CAR as a potential game-changing therapeutic approach to treat cancer patients. Kite will focus its efforts and resources to advance the NCI clinical product pipeline into multi-center studies aimed at successful registration and commercialization."

The CRADA will focus on:

(1) evaluation of the clinical safety and efficacy of current and future NCI proprietary eACT/TCR/CAR products in relevant cancer indications and the development of optimized clinical protocols;

(2) optimization of eACT/TCR/CAR product manufacturing and characterization in compliance with cGMP, suitable for large multi-center trials and commercialization to broad patient populations; and

(3) generation and advancement to clinical trials of additional eACT/TCR/CAR products and the development of technologies to enhance eACT/TCR/CAR product potency and durability of clinical response.

"I am excited to again join forces with Dr. Rosenberg whose pioneering and lifelong work in adoptive T cell therapy has demonstrated its potential for the treatment of incurable cancers" said Arie Belldegrun, M.D., Founder and Executive Chairman of Kite. "Combining the basic and translational research expertise at the Surgery Branch with Kite’s development expertise and capabilities positions us well to accomplish our goal of becoming a leader for innovative cancer immunotherapy products."