GI Innovation has dosed the first patient in a Phase 1 clinical trial of GI-102, a subcutaneous (SC) formulation of an immune-oncology drug. This marks the first time a Korean company has initiated SC administration for an immune-oncology drug, following MSD's SC version of Keytruda (pembrolizumab). The trial is evaluating GI-102's potential use in melanoma, among other indications.
Strategic Shift to Subcutaneous Delivery
GI Innovation began developing SC formulations in 2021, aligning with a global trend to transition blockbuster immune-oncology drugs like Keytruda, Roche’s Tecentriq (atezolizumab), and Bristol Myers Squibb’s Opdivo (nivolumab) to SC delivery methods. This strategic move is seen as a way to extend market presence as drug patents near expiration and to potentially dominate treatment protocols in the coming years.
Enhanced Efficacy and Patient Convenience
The company anticipates that GI-102's SC formulation will enhance efficacy compared to intravenous (IV) administration. Previous studies showed an objective response rate (ORR) of 30 percent in metastatic melanoma patients who had exhausted standard treatments. Preclinical trials in monkeys indicated that SC delivery activates immune cells as effectively as IV administration, with no safety concerns. For melanoma, the SC formulation is expected to improve both ease of administration and therapeutic outcomes.
Trial Details and Participating Institutions
The Phase 1 trial is being conducted at 14 medical institutions in Korea and the United States, including Mayo Clinic, Cleveland Clinic, Memorial Sloan Kettering Cancer Center, Samsung Medical Center, and Seoul National University Hospital. Samsung Biologics is handling GMP production to expedite regulatory approvals.
Professor Kim Seung-tae from Samsung Medical Center, who administered the first dose, stated, "The patient has shown stable progress one week after dosing. Given the strong patient preference for SC formulations, we expect the trial to progress swiftly."
Future Prospects
Jang Myung-ho, chief scientific officer at GI Innovation, noted that the Phase 1 trial is expected to conclude by February 2025. "Global pharmaceutical companies are showing significant interest in the clinical data for GI-102 SC, which we believe will greatly enhance our negotiating power for technology licensing," he said.
