Korean biopharmaceutical company GI Innovation said Monday that the first patient has been dosed in a phase 1 clinical trial of GI-102, an immune-oncology drug in a subcutaneous injection (SC) formulation. The drug’s indications, including its potential use for melanoma, have not yet been confirmed.

The company said this marks the first time a Korean firm has initiated SC administration for an immune-oncology drug, following MSD’s SC version of Keytruda (pembrolizumab), which pairs Merck’s anti-PD-1 therapy with Alteogen’s hyaluronidase variant, berahyaluronidase alfa.

GI Innovation began working on SC formulations in 2021, anticipating their advantages and aligning with a global trend to transition blockbuster immune-oncology drugs—including Keytruda, Roche’s Tecentriq (atezolizumab), and Bristol Myers Squibb’s (BMS) Opdivo (nivolumab)—to SC delivery methods.

These formulations are seen as a strategy to extend market presence as drug patents near expiration and are expected to dominate treatment protocols in the coming years.

According to the company, GI-102’s SC formulation is expected to 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, a type of skin cancer, the SC formulation is anticipated to improve both ease of administration and therapeutic outcomes, according to a GI Innovation official.

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.

“The patient has shown stable progress one week after dosing,” said Professor Kim Seung-tae from Samsung Medical Center, who administered the first dose. “Given the strong patient preference for SC formulations, we expect the trial to progress swiftly.”

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.