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GEN News Highlights: January 10, 2017

Fosun, Daiichi Sankyo Ink Deals for Kite's CAR T-Cell Therapy in China and Japan

  • Kite Pharma has negotiated separate agreements with Fosun Pharma and with Daiichi Sankyo for the development of its lead CD19 chimeric antigen receptor (CAR) T-cell autologous cell therapy, axicabtagene ciloleucel (KTE-C19), in Japan and China, respectively.  In December 2016, Kite reported initiating a rolling submission of a Biologics License Application (BLA) to the FDA for KTE-C19 as a treatment for refractory, aggressive non-Hodgkin's lymphoma (NHL).

    Kite and Fosun are setting up a Shanghai-registered joint venture, with the proposed name Fosun Pharma Kite Biotechnology, to develop, commercialize, and manufacture KTE-C19, and potentially other Kite products, in China. The joint venture will be owned equally by the two partners. Kite will receive an up-front payment of $40 million from the joint venture, funded by Fosun, and another $20 million in funding from Fosun to support clinical development and manufacturing. Kite could receive up to $35 million in regulatory and commercial milestones relating to KTE-C19 development, plus future sales royalties. Profits from the joint venture will be shared 40/60 between Kite and Fosun respectively. 

    The joint venture will in addition have the option to license Kite’s KITE-439, a T-cell receptor (TCR) therapy directed against the human papillomavirus type 16 E7 oncoprotein, and KITE-718, a TCR therapy directed against melanoma-associated antigen 3 (MAGE-A3) and MAGE-A6. Opt-in and milestone payments for the two products could total $140 million, plus profit sharing and sales royalties. At the start of January 2017, Kite submitted an IND application with the FDA to start a Phase I trial with KITE-718 in solid tumors. Kite says KITE-718 builds on proof-of-concept work by the National Cancer Institutes and has been optimized through next-generation cell manufacturing technologies.

    "This joint venture allows us to access a critically important market and meet a major objective of expanding our global reach,” stated Arie Belldegrun, M.D., FACS, Kite’s chairman, president, and CEO. “Fosun Pharma is an innovator and market-maker, which makes them an ideal partner to develop and commercialize axicabtagene ciloleucel in China."

    Daiichi Sankyo is separately paying Kite $50 million upfront for the Japanese rights to KTE-C19 in Japan. Under terms of the strategic partnership deal, Daiichi Sankyo will develop and commercialize KTE-C19 in Japan. Kite could receive potentially $200 million in milestones, plus future sales royalties. Daiichi Sankyo also has an option, for an undisclosed period of time, to license additional Kite products for the Japanese market, including KITE-718 and other specific product candidates that reach U.S. IND filing over the next 3 years. Up-front and milestone payments for each additional Kite candidate licensed by Daiichi Sankyo could reach $200 million. Kite retains all development and commercialization rights to its products outside of Japan.

    "We are very enthusiastic about this partnership with Kite, which has the most advanced technology platform in this area and the potential for cell-based therapy to change the way in which we treat cancer in Japan," commented Koichi Akahane, Japan head of oncology R&D at Daiichi Sankyo. "We believe we can leverage the pioneering research conducted by Kite to potentially accelerate development and commercial availability of axicabtagene ciloleucel in Japan for those patients suffering from B-cell malignancies."

    "We have a strategic roadmap to commercialize axicabtagene ciloleucel globally while focusing Kite's development and commercialization efforts in the U.S. and Europe," Dr. Belldegrun stated. “Daiichi Sankyo's commitment to bring autologous T-cell therapy to patients in Japan will complement our strategy and demonstrates the significant value in our pipeline, as well as the commercial potential for autologous T-cell therapy globally."

    Kite is focused on developing engineered autologous cell therapies (eACT™) that restore the immune system's ability to recognize and eradicate tumors. Axicabtagene ciloleucel has been granted breakthrough therapy designation status by the FDA for diffuse large B-cell lymphoma (DLBCL), transformed follicular lymphoma (TFL), and primary mediastinal B-cell lymphoma (PMBCL), as well as priority medicines (PRIME) regulatory support for the DLBCL indication in the EU. Earlier this month Moffitt Cancer Center researchers reported promising data from the Phase I stage of the ZUMA-1 trial evaluating KTE-C19 in the treatment of B-cell lymphoma. In December 2016 Kite reported positive data from the Phase I ZUMA-3 and ZUMA-4 trials evaluating KTE-C19 in adult and pediatric relapsed/refractory acute lymphoblastic leukemia.