Kite Pharma, Inc., a clinical-stage biopharmaceutical company focused on developing immunotherapies for the treatment of cancer, has amended its Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI), which includes optimizing new methods for manufacturing. Kite is focused on developing engineered autologous T cell therapy (eACT) therapies. In January 2015, the company also signed a research collaboration and license agreement with Amgen.

The amended NCI pact will encompass emerging areas of research in the immune response to tumor neo-antigens, truly tumor-specific antigens generated as tumors accumulate genetic mutations. In addition, new T cell receptor (TCR) and new chimeric antigen receptor (CAR) product candidates targeting solid tumors have been added to the collaboration. The amendment broadens Kite’s ongoing research collaboration with the Surgery Branch at the NCI, led by Steven A. Rosenberg, M.D., Ph.D. and provides additional product candidates for Kite’s growing pipeline.

Under Kite’s amended agreement with the NCI, the additional programs will encompass: methods of rapidly identifying and developing TCR product candidates targeted against neo-antigens; optimizing new methods to manufacture this new class of individualized therapies; and developing additional TCR product candidates retrovirally engineered to target tumor antigens, including for the treatment of colorectal and lung cancers.

Earlier this year, Kite Pharma, based in Santa Monica, California, formed a a strategic research collaboration and license agreement with Amgen to develop and commercialize CAR T cell immunotherapies based on Kite’s eACT platform and Amgen’s cancer targets. Under the agreement, Amgen is contributing cancer targets, and Kite is providing its proprietary CAR platform, research and development (R&D), and manufacturing capabilities. Under the deal, Kite received from Amgen an upfront payment of $60 million, as well as funding for R&D costs through investigational new drug (IND) filing. Kite is eligible to receive up to $525 million in milestone payments per Amgen program based on the successful completion of regulatory and commercialization milestones, plus tiered high single- to double-digit royalties for sales and the license of Kite’s intellectual property for CAR T cell products. Amgen is eligible to receive up to $525 million in milestone payments per Kite program, plus tiered single-digit sales royalties.

Earlier this year, Kite Pharma formed a lease agreement for a commercial manufacturing facility in El Segundo, California and also recently secured a lease for a clinical manufacturing facility in Santa Monica, California. The two facilities will support the planned clinical trials of Kite’s product candidates, but also will prepare Kite for the commercial launch and supply of its lead product candidate, KTE-C19, anticipated in 2017.

The Santa Monica facility has approximately 18,000 square feet and will provide space for clinical manufacturing, research and development, and offices upon completion. In addition, Kite plans to continue to use its contract manufacturer to support clinical trials of eACT-based product candidates. eACT are Kite’s proprietary peripheral blood product candidates, both CAR and TCR products, directed to a wide range of cancer indications. The El Segundo facility has approximately 44,500 square feet, and, under the lease agreement, Kite has an expansion option for an additional 17,000 square feet until July 1, 2017. Kite anticipates the El Segundo facility will be operational to support the planned commercial launch of KTE-C19 in 2017.

Kite’s manufacturing process for its lead product, KTE-C19. enables a patient’s T cells to be genetically modified using a gammaretroviral vector to express a chimeric antigen receptor  designed to target the antigen CD19, a protein expressed on the cell surface of B cell lymphomas and leukemias. Kite recently announced filing with the US Food and Drug Administration for an IND application to conduct a Phase I/II clinical trial of KTE-C19 for the treatment of patients with refractory aggressive non-Hodgkin lymphoma.

Source: Kite Pharma