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Ono Pharmaceutical Exercises Option to Jointly Develop CAR T-Cell Therapy With Fate Therapeutics

NEW YORK – Fate Therapeutics on Monday said that Ono Pharmaceutical has exercised its option to the HER2-targeted CAR T-cell therapy, FT825/ONO-8250. 

Under the terms of the option agreement, Osaka, Japan-based Ono and San Diego-based Fate will jointly develop the off-the-shelf cell therapy in the US and Europe, while Ono will exclusively develop it elsewhere. In exchange, Fate will receive a milestone payment for an undisclosed amount and will be eligible for additional payments if it achieves certain clinical and regulatory milestone payments as well as tiered royalties if the treatment is commercialized outside the US and Europe. 

The partnered firms are aiming to submit an investigational new drug application with the US Food and Drug Administration and begin clinical evaluations for FT825/ONO-8250 in 2023. 

The CAR T-cell therapy is a multiplexed-engineered, induced pluripotent stem cell (iPSC)-derived therapy that targets solid tumor cells expressing HER2. FT825/ONO-8250 comprises Ono's antigen binder and Fate's iPSC product platform. The treatment, which is still in preclinical development, is designed to overcome challenges of treating solid tumors with CAR T-cell therapies, including inefficient CAR T-cell trafficking to cancer cells and immunosuppression in the tumor microenvironment. 

"The preclinical data indicate FT825/ONO-8250 has a highly differentiated therapeutic profile, including exhibiting anti-tumor activity against HER2-low tumor cells," Fate CEO and President Scott Wolchko said in a statement. "We are excited to initiate IND-enabling activities under our collaboration with Ono." 

Additionally, Fate and Ono recently expanded their collaboration to develop another treatment against a solid tumor antigen, though they did not provide further details.