The Phase I clinical trial will enrol patients with advanced solid tumours who have received prior treatment. Credit: Peakstock / Shutterstock.

US-based biopharmaceutical company Fate Therapeutics has begun a Phase I clinical trial of its chimeric antigen receptor (CAR) T-cell therapy, FT825 / ONO-8250, to potentially treat advanced solid tumours.

A human epidermal growth factor receptor 2 (HER2) directed product candidate, FT825 / ONO-8250 is an induced pluripotent stem cell (iPSC) derived CAR T-cell treatment.

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The trial aims to assess the therapy’s tolerability and safety both as a single agent and in combination with monoclonal antibody therapy in subjects who have received prior treatment.

It will include dose escalation and dose expansion stages to assess FT825 / ONO-8250’s pharmacokinetics and anti-tumour activity.

Duration of response, overall response rate and disease control rate will be used as the metrics to evaluate anti-tumour activity.

Fate Therapeutics is carrying out the trial in partnership with Ono Pharmaceutical.

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The companies have signed a Collaboration and Option Agreement for the co-development and marketing of FT825 / ONO-8250 in the US and Europe.

Ono Pharmaceutical retains the sole rights for developing and commercialising the drug in other markets worldwide.

Fate Therapeutics stands to gain clinical, regulatory and commercial milestone payments, in addition to royalty payments on net product sales outside the agreed territories, from Ono.

The two companies are currently working together on the preclinical development of another solid tumour programme directed at an unnamed tumour-associated antigen.

Fate Therapeutics president and CEO Scott Wolchko said: “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 I study in collaboration with Ono and assess the potential to benefit patients with hard-to-treat advanced solid tumours who currently have limited treatment options.”

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