Date: 2017-01-09
Type of information: Development agreement
Compound: axicabtagene ciloleucel (KTE-C19 (autologous T cells transduced with retroviral vector encoding an anti-CD19 CD28/CD3 zeta chimeric antigen receptor) and atezolizumab
Company: Kite Pharma (USA - CA) Daiichi Sankyo (Japan)
Therapeutic area: Cancer - Oncology - Rare diseases
Type agreement: development licensing commercialisation
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. 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 non-Hodgkin lymphoma (NHL).
Disease:
Details: * On January 9, 2016, Kite Pharma announced that it has entered into a strategic partnership with Daiichi Sankyo for axicabtagene ciloleucel (KTE-C19) in Japan . Under the terms of the partnership agreement, Daiichi Sankyo will be responsible for development and commercialization of axicabtagene ciloleucel in Japan . As part of the transaction, Kite will provide certain technical transfer services to Daiichi Sankyo. In addition, Daiichi Sankyo has a certain period of time to license additional Kite product candidates for Japan including KITE-718, Kite's T cell receptor product candidate targeting MAGE-A3/A6 and certain other product candidates that proceed to a U.S. investigational new drug application filing over the next three years. Upfront and milestone payments for each additional product candidate could equal up to $200 million plus low to mid double digit sales royalties. Kite retains all development and commercialization rights outside of Japan .
Financial terms: Daiichi Sankyo will make an upfront payment to Kite of $50 million and Kite will be eligible to receive future payments totaling up to $200 million for development and commercial milestones. Kite is also entitled to receive sales royalties in the low to mid double digit range.
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