Kite Pharma has forged cancer immunotherapy alliances in Japan and China as it expands its business into Asian markets.
In China, Kite has formed a joint venture with Chinese drugmaker Fosun Pharma to develop lead chimeric antigen receptor T cell (CAR-T) therapy axicabtagene ciloleucel (also known as KTE-C19), which has been submitted for approval in the US via a rolling marketing application.
That deal nets the US biotech $40m in upfront payments, plus $20m of funding to support clinical development and manufacturing and $35m in regulatory and commercial milestones, and Kite will own 50% of the new company.
The Shanghai-based JV has also taken an option to develop two other candidates - KITE-718, a MAGE A3/A6-directed therapy for solid tumours, and KITE-439, which targets human papillomavirus type 16 E7 oncoprotein. Opt-in and milestone payments for these two candidates could reach $140m.
Kite's Japanese partnership is with Daiichi Sankyo and will see Kite receive $50m upfront and $200m in development and commercial milestone payments in return for rights to axicabtagene ciloleucel. Daiichi Sankyo is also taking an option to license KITE-718 plus "certain other product candidates that proceed to a US investigational new drug application filing over the next three years".
Kite has submitted axicabtagene ciloleucel as a treatment for patients with refractory aggressive non-Hodgkin lymphoma (NHL) in the US, and is vying with Novartis to be the first company to win marketing approval anywhere in the world for a CAR-T therapy.
The therapy involves harvesting patient's T cells and engineering them to express a chimeric antigen receptor (CAR) that targets CD19, an antigen expressed on the cell surface of B-cell lymphomas and leukaemias, which redirects the T cells to kill cancer cells.
The two new deals could unlock a sizeable new patient population for axicabtagene ciloleucel - there are approximately 73,000 newly-diagnosed cases of NHL in China each year, while Japan has around 9,300 new cases.