NKMAX Completes First Patient Dosing in US Solid Tumor Clinical Trial of Same-Type NK Cell Therapy

NKMAX has started the first administration of the allogeneic NK cell therapy (SNK02) Phase 1 clinical trial in the United States.

NKMAX announced on the 25th that its subsidiary, NKGEN Biotech, has completed the first patient dosing in the SNK02 Phase 1 clinical trial in the U.S., targeting patients with solid tumors.

The patient is scheduled to receive intravenous administration of SNK02 weekly for 8 weeks. This clinical trial evaluates the safety and tolerability of SNK02 in patients with advanced solid tumors who have failed at least one standard treatment.

SNK02, cultured from healthy donor NK cells, is a high-purity, high-activity allogeneic NK cell therapy incorporating NKMAX’s unique technology. NKMAX also possesses technology that maintains excellent purity and activity even after the cryopreservation process. The U.S. Food and Drug Administration (FDA) highly evaluated the safety of SNK02 and approved skipping the dose escalation process to administer the maximum dose of 6 billion cells.

Paul Y. Song, CEO of NKGEN Biotech, said, “We are pleased to administer SNK02 to the first patient in the Phase 1 clinical trial targeting patients with solid tumors who have limited treatment options,” adding, “SNK02 is the first allogeneic NK cell therapy for solid tumors that does not require lymphodepletion before administration.”

He continued, “Omitting lymphodepletion may help preserve immune function in patients with advanced solid tumors who have already undergone many treatments,” emphasizing, “The SNK02 therapy could bring higher synergy effects in combination therapies with immune checkpoint inhibitors that require strong T cell responses in the future.”

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