Date: 2017-01-10
Type of information: Joint-venture agreement
Compound: axicabtagene ciloleucel (KTE-C19), KITE-439 and KITE-718
Company: Kite Pharma (USA - CA) Fosun Pharma (China)
Therapeutic area: Cancer - Oncology
Type agreement: joint-venture
Action mechanism: cell therapy/immunotherapy product/gene therapy/CAR-T cell therapy. KTE-C19 is Kite Pharma's lead product candidate in which a patient's T cells are genetically modified using a gammaretroviral vector to express a chimeric antigen receptor (CAR) designed to target the antigen CD19, a protein expressed on the cell surface of B cell lymphomas and leukemias.
Disease:
Details: * On January 10, 2017, Kite Pharma and Shanghai Fosun Pharmaceutical announced a joint venture, Fosun Pharma Kite Biotechnology, to develop, manufacture and commercialize axicabtagene ciloleucel in China with the option to include additional products, including two T cell receptor (TCR) product candidates from Kite. Axicabtagene ciloleucel (KTE-C19)is under development for the treatment of B-cell lymphomas and leukemias.
The joint venture will be registered in Shanghai and owned equally between Kite Pharma , a pioneer in the field of engineered T-cell therapy for cancer, and Fosun Pharma, a leading healthcare group in China .
The joint venture will initially focus on axicabtagene ciloleucel, Kite's lead CAR product candidate for the treatment of B-cell lymphomas and leukemias. Kite announced in December 2016 that it has initiated the rolling submission to the FDA of the Biologics License Application (BLA) for KTE-C19 as a treatment for patients with refractory aggressive B-cell NHL .
Financial terms: Under the terms of the agreement, Fosun Pharma will provide the RMB equivalent of $20 million in funding to support clinical development and manufacturing activities and Kite will provide certain technical transfer services to the joint venture. Each party will share in any profits from the joint venture with Kite Pharma receiving 40 percent and Fosun Pharma receiving 60 percent. Kite will also receive an upfront fee of $40 million from the joint venture, funded by Fosun Pharma, regulatory and commercial milestones totaling $35 million and mid-single digit sales royalties for axicabtagene ciloleucel (KTE-C19). The joint venture will also have the option to license additional product candidates including KITE-439, a TCR therapy directed against the human papillomavirus type 16 E7 oncoprotein and KITE-718, a TCR therapy directed against MAGE A3 and MAGE A6, antigens frequently found in solid tumors including bladder, esophageal, head and neck, lung and ovarian cancers. Opt-in and milestone payments for KITE-439 and KITE-718 could total $140 million plus profit sharing and mid-single digit sales royalties.
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