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Cell & Gene Therapy Insights

Cell & Gene Therapy Insights

First cancer patient treated with iPSC-derived natural killer cells

Fate Therapeutics has announced that the first patient treated with its lead product candidate, FT500 has successfully completed its Phase 1 safety assessment. This universal, off-the-shelf natural killer (NK) cell product candidate is the first cell therapy derived from an induced pluripotent stem cell (iPSC) administered to a patient in the US.

FT500 was developed by researchers, Dr Dan Kaufman of UC San Diego Health and Dr Jeffrey S. Miller of the Masonic Cancer Center in collaboration with Fate Therapeutics.

The first patient, Derek Ruff with a stage IV colon cancer received FT500 in February this year as part of a Phase I clinical trial at Moores Cancer Center at UC San Diego Health. Derek received three once weekly doses of FT500, 1×108 cells per dose.

The treatment was well-tolerated with no serious adverse events reported during the initial 28-day observation period. Two additional patients have also been treated with FT500 as a monotherapy in the first dose cohort of 1×108 cells per dose and are currently in the initial 28-day observation period.

The ongoing Phase 1 trial is designed to evaluate the safety and clinical outcome of three once weekly doses of FT500 as a monotherapy and in combination with one of three FDA-approved checkpoint inhibitor therapies – nivolumab, pembrolizumab or atezolizumab – in patients with advanced solid tumors where previous treatments have not worked or who have confirmed disease progression on checkpoint inhibitor therapy. Patients who are clinically stable following the initial 28-day observation period will be eligible to receive a second dose of FT500. Upto 64 patients will receive one of the treatments. The trial was initiated following successful approval of the IND by the FDA in November last year.

Data from preclinical studies conducted in cells and mouse models revealed that the treatment was effective in killing cancer cells. NK cells are specialized immune cells that have been shown to possess anti-tumor effect. Whereas other studies use NK cells isolated from patients’ blood, the present trial uses NK cells derived from human iPSCs. Since human iPSCs can differentiate into potentially any cell type in the body, using them as starting materials to produce NK cells would be a significant achievement in terms of cost and time, if proven to be a success in forthcoming trials.

Dr Dan Kaufman commented: “This is a landmark accomplishment for the field of stem cell-based medicine and cancer immunotherapy. This clinical trial represents the first use of cells produced from human induced pluripotent stem cells to better treat and fight cancer. We are continuing to collaborate with Fate Therapeutics to develop additional versions of iPSC-derived cancer immunotherapies, including the first engineered iPSC-derived product candidates to move into clinical testing later in 2019.”

Source: Fate Therapeutics Announces FDA Clearance of Landmark IND for FT500 iPSC-derived, Off-the-Shelf NK Cell Cancer Immunotherapy; Press Release

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