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Fate Therapeutics Initiates Enrollment for Phase 1 Clinical Trial of FT825/ONO-8250


Shares of Fate Therapeutics rise by 13% on announcement of Phase 1 clinical trial enrollment

Fate Therapeutics has commenced enrollment for its Phase 1 clinical trial of FT825/ONO-8250, a groundbreaking cancer treatment developed in collaboration with Ono Pharmaceutical. The potential treatment for solid tumors was created using Fate Therapeutics’ innovative iPSC Product Platform.

Investigating the Efficacy of FT825/ONO-8250

The Phase 1 study aims to investigate the effectiveness of a single dose of FT825/ONO-8250 as monotherapy and in combination with monoclonal antibody therapy in previously-treated patients with advanced solid tumors. The trial will encompass both dose escalation and dose expansion portions, offering insights into safety, tolerability, and pharmacokinetics. Additionally, the study will evaluate anti-tumor activity through overall response rate, duration of response, and disease control rate.

Collaborative Development and Commercialization

Under the collaboration and option agreement with Ono, Fate will collaborate with Ono in jointly developing and commercializing FT825/ONO-8250 in the United States and Europe. In the remaining regions of the world, Ono will hold exclusive development and commercialization rights for FT825/ONO-8250. This partnership opens up avenues for global impact through a combined effort.

Potential Benefits for Fate Therapeutics

In recognition of their contributions, Fate is eligible to receive clinical, regulatory, and commercial milestone payments. Additionally, tiered royalties on net sales outside of the United States and Europe will further reward Fate for their valuable work.

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