Fate Therapeutics initiates phase 1 trial for solid tumour treatment

Betsy Goodfellow | January 9, 2024 | News story | Research and Development Fate Therapeutics, Oncology, solid tumours 

Fate Therapeutics has announced that it has begun enrollment for the phase 1 clinical trial of FT825/ONO-8250, a multiplexed-engineered, chimeric antigen receptor (CAR) T-cell product candidate which targets human epidermal growth factor receptor 2 (HER2).

This CAR T-cell candidate is intended to overcome challenged in the treatment of solid tumours.

The phase 1 trial of this candidate is being conducted as part of a strategic collaboration with Ono Pharmaceutical. The trial will investigate a single dose of the therapy as a monotherapy and in combination with monoclonal antibody therapy in previously-treated patients with advanced solid tumours.

Scott Wolchko, president and chief executive officer of Fate Therapeutics, commented: “Since the formation of our partnership with Ono in 2018, we have worked closely together to pioneer the manufacture of CD8 alpha-beta T-cells from iPSCs and to discover and integrate novel synthetic controls of cell function into our iPSC-derived CAR T-cell product platform for safe and effective treatment of solid tumours, including functional elements designed to promote cell trafficking, resist immune suppression in the tumour microenvironment and preferentially target cancer cells. The preclinical data for FT825/ONO-8250 indicate a highly-differentiated therapeutic profile across a broad range of solid tumours, with the novel HER2-targeted antigen binding domain demonstrating selective targeting of cancer cells expressing HER2 including those with low expression. We are excited to initiate the phase 1 study in collaboration with Ono and assess the potential to benefit patients with hard-to-treat advanced solid tumors who currently have limited treatment options.”

Betsy Goodfellow

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