T-cell therapeutics specialist Kite Pharma and the National Cancer Institute established a Cooperative Research and Development Agreement (CRADA) to develop and commercialize engineered peripheral blood autologous T-cell therapeutics (eACT) for treating multiple cancer indications. The deal gives Kite exclusive access to NCI’s current and future clinical pipeline of autologous peripheral blood T cells engineered using the latter’s tumor-specific T-cell receptors (TCRs), and chimeric antigen receptors (CARs), which are designed to target multiple blood and solid tumor types. The technology has been developed by team at NCI’s Surgery Branch, led by Steven A. Rosenberg. M.D.

More specifically, the CRADA will focus on evaluating the clinical safety and efficacy of NCI’s eACT/TCR/CAR products in relevant cancer indications, generating an optimized large-scale cGMP manufacturing process for the products to allow multicenter trials and commercialization, and progressing new eACT/TCR/CAR products to clinical and developing technologies to further improve product potency.

NCI-conducted clinical trials evaluating peripheral blood T cells engineered with TCRs or CARs have already demonstrated significant, durable clinical responses in cancer patients with advanced metastatic cancers, including refractory melanoma, sarcoma, lymphoma, and leukemia. “We regards eACT/TCR/CAR as a potential game-changing therapeutic approach to treat cancer patients,” comments Kite president and CEO Aya Jakobovits, M.D. “Kite will focus its efforts and resources to advance the NCI clinical product pipeline into multicenter studies aimed as successful registration and commercialization.”

Kite was founded to work in partnership with Dr. Rosenberg’s team at NCI’s Surgery Branch to develop and commercialize the adoptive T-cell therapeutics platform. The firm raised $15 million in an initial round of private financing back in March 2011.

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