SEOUL, December 23 (AJP) - South Korean biotechnology company GI Innovation announced on Monday that it has dosed the first patient in a Phase 1 clinical trial of its subcutaneous (SC) immunotherapy drug, GI-102. This marks a significant milestone for the company, as it is the first domestic company to administer an SC formulation of its own immunotherapy.
The Phase 1 trial is being conducted at 14 medical institutions across South Korea and the United States. Samsung Biologics Co. is responsible for the good manufacturing practice (GMP) production of the drug.
Previous clinical trials of GI-102's intravenous formulation demonstrated a 30 percent objective response rate in patients with metastatic melanoma who had failed standard treatments. The new SC formulation is expected to significantly reduce administration time from several hours to approximately 10 minutes, while potentially enhancing therapeutic efficacy.
"The patient who received the GI-102 subcutaneous injection has shown stable conditions up to one week after administration," said Kim Seung-tae, Professor at Samsung Seoul Hospital's Department of Oncology.
The trial, which comprises two cohorts, is anticipated to be completed by the end of February 2025.
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