GI Innovation’s Subcutaneous Immune-Oncology Therapy Enters Phase 1 Trial

Today, South Korean biotech company GI Innovation announced that the first patient had been treated in a phase 1 clinical trial for GI-102, its new immune-oncology drug delivered via a subcutaneous (SC) injection. While the specific conditions GI-102 will target, including melanoma, are still under review, this milestone marks a significant step for the company.

Notably, GI Innovation is the first Korean company to introduce SC administration for an immune-oncology drug, following the lead of MSD’s SC version of Keytruda (pembrolizumab), which combines Merck’s anti-PD-1 therapy with Alteogen’s hyaluronidase variant, berahyaluronidase alfa.

“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,”  stated Professor Kim Seung-tae from Samsung Medical Center, who administered the first dose.

GI Innovation began focusing on SC formulations in 2021, anticipating their advantages in line with a global shift. Major immune-oncology drugs like Keytruda, Roche’s Tecentriq (atezolizumab), and BMS’s Opdivo (nivolumab) are also transitioning to SC delivery as patents expire, with the SC format expected to dominate future treatment options. 

Jang Myung-ho, chief scientific officer at GI Innovation, mentioned, “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.”

The company believes GI-102’s SC formulation could offer superior benefits over intravenous (IV) methods. Earlier trials reported a 30% objective response rate (ORR) in metastatic melanoma patients without treatment options. Preclinical monkey tests showed that SC delivery effectively activated immune cells, matching IV results while maintaining a favourable safety profile.

For melanoma, a deadly form of skin cancer, SC administration is expected to improve patient convenience and treatment outcomes. The phase 1 trial is being conducted at 14 leading medical centres in Korea and the U.S., including Mayo Clinic, Cleveland Clinic, Memorial Sloan Kettering Cancer Center, Samsung Medical Center, and Seoul National University Hospital. Samsung Biologics manages GMP production to fast-track regulatory approvals.