Fate announces exercise by ONO of option to FT825/ONO-8250

Fate Therapeutics (FATE) announced that ONO Pharmaceutical (OPHLY) has exercised its option to FT825/ONO-8250, a multiplexed-engineered, iPSC-derived, chimeric antigen receptor T-cell product candidate targeting human epidermal growth factor receptor 2-expressing solid tumors. The preclinical product candidate incorporates multiple functional elements to enhance the activity and overcome unique challenges in treating solid tumors with cell-based cancer immunotherapies. Under the terms of the Collaboration and Option Agreement, Fate will receive a milestone payment in connection with ONO’s exercise of its option to FT825/ONO-8250. The parties will jointly develop and commercialize FT825/ONO-8250 in the U.S. and Europe, and ONO maintains exclusive development and commercialization rights for FT825/ONO-8250 in the rest of the world. Fate is eligible to receive clinical, regulatory and commercial milestone payments as well as tiered royalties on net sales outside of the United States and Europe by ONO. "Over the past four years, we have worked closely with ONO to discover and integrate novel functional elements into our iPSC-derived CAR T-cell product platform that are specifically designed to address challenges in treating solid tumors, including cell trafficking and immune cell suppression in the tumor microenvironment," said Scott Wolchko, President and Chief Executive Officer of Fate Therapeutics. "The preclinical data indicate FT825/ONO-8250 has a highly-differentiated therapeutic profile, including exhibiting anti-tumor activity against HER2-low tumor cells. We are excited to initiate IND-enabling activities under our collaboration with ONO with the goal of submitting an IND application to FDA in 2023."