NKGen Biotech has dosed the first patient in a Phase I clinical trial of SNK02, an allogeneic blood-derived natural killer (NK) cell therapy to treat solid tumours.
The initiation is based on the approval from the US Food and Drug Administration to NKGen’s investigational new drug application of SNK02 in October last year.
The dose-escalation, open-label, multi-centre study will assess the tolerability and safety of SNK02 in pathologically confirmed solid tumour patients refractory to standard of care therapy.
They will receive the study drug weekly for eight weeks as an intravenous infusion.
NKGen CEO Paul Song said: “SNK02 seeks to be one of the first cryopreserved allogeneic NK cell therapy for solid tumours that does not require lymphodepletion before administration.
“We believe the lack of lymphodepletion has the potential to better preserve the already fragile immune function of heavily pre-treated cancer patients with advanced disease.
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“If successful, this therapy may lead to better overall synergy in future combination regimens with immune checkpoint inhibitors where a robust T-cell response is needed.”
SNK02 is produced using NKGen’s proprietary allogeneic manufacturing process. It is expected to possess 99% purity and high receptor expression rates.
The cryopreservation process allows to maintain cytotoxicity further making SNK02 an off-the-shelf candidate for trials.
It can also produce several potential doses of NK cell therapies from materials collected from a single donor.
In June this year, the company reported preclinical and Phase I/IIa clinical data of SNK01 along with cytotoxic chemotherapy to treat non-small cell lung cancer patients who failed prior tyrosine kinase inhibitor treatment.
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