Daiichi Sankyo has formed a partnership in Japan with Kite Pharma, a clinical-stage biopharmaceutical company headquartered in Santa Monica, California, for Kite’s lead product candidate, axicabtagene ciloleucel (formerly KTE-C19), an investigational chimeric antigen receptor T cell (CAR T) therapy under development for treating B-cell lymphomas and leukemias.

Under the agreement, Daiichi Sankyo will be responsible for development and commercialization of axicabtagene ciloleucel in Japan. The company 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. Kite’s lead product candidate, axicabtagene ciloleucel, is an investigational therapy in which a patient’s T cells are engineered to express a CAR to target the antigen CD19, a protein expressed on the cell surface of B-cell lymphomas and leukemias, and redirected to the cancer cells.

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 melanoma associated antigen 3/6 (MAGE-A3/A6) and certain other product candidates that proceed to a US 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.

Kite announced in December 2016 that it has initiated the rolling submission to the US Food and Drug Administration of the biologics license application for axicabtagene ciloleucel for treating patients with refractory aggressive non-Hodgkin lymphoma.

Source: Kite Pharma