GI Innovation Announces Clinical Trial Collaboration for GI-102 with KEYTRUDA in Resistant Liver Cancer, Melanoma, and Renal Cell Carcinoma

SEOUL, South Korea--The South Korean biotech firm GI Innovation has entered into a clinical trial collaboration and supply agreement with MSD, known as Merck & Co., Inc., Rahway, NJ, USA. This partnership aims to evaluate the combined treatment of GI-102 and MSD's anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), in patients who have shown resistance to immunotherapy for liver cancer, melanoma, and renal cell carcinoma.

This is the second collaboration between GI Innovation and MSD, following a prior clinical trial involving GI-101A. The upcoming Phase 2 clinical trial will focus on patients who have not responded to existing immuno-oncology treatments and have exhausted other treatment options. The primary targets of this trial are metastatic liver cancer, melanoma, and renal cell carcinoma, diseases with significant market potential and a likelihood of successful treatment outcomes.

GI Innovation has already achieved promising results with GI-102. In a monotherapy trial for melanoma patients unresponsive to standard treatments, the overall response rate (ORR) was 42.9%, with three partial responses out of seven patients. In preclinical studies, complete tumor regression was observed in 60% of mice treated with GI-102 monotherapy for liver cancer.

The Phase 2 trial will be conducted across fourteen hospitals in South Korea and internationally recognized medical centers in the United States. Participating institutions include the Mayo Clinic (with campuses in Rochester, Florida, and Arizona), Cleveland Clinic, and Memorial Sloan Kettering Cancer Center. In South Korea, leading hospitals such as Samsung Medical Center, Asan Medical Center, Seoul National University Hospital, Severance Hospital of Yonsei University, and St. Vincent’s Hospital will be involved.

Dr. Myung-Ho Jang, Chief Scientific Officer of GI Innovation, expressed enthusiasm about the partnership with MSD, highlighting the potential to enhance the therapeutic efficacy of GI-102 through its combination with KEYTRUDA, MSD’s renowned anti-PD-1 therapy. 

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