The aim is to conduct genomic profiling using tumor tissue samples in GI-101-P101, an open-label, dose-escalation, and expansion phase 1/2 clinical study to evaluate the safety, tolerability, pharmacokinetics, and therapeutic activity of GI-101 as a single agent, and in combination with KEYTRUDA® (pembrolizumab), LENVIMA® (lenvatinib), or local radiotherapy in 400 patients with advanced solid tumors. The study is being led by GI Innovation and run in collaboration with Merck, known as MSD outside the United States and Canada.

“As biomarkers are playing increasingly critical roles in the development of new immuno-oncology drugs, they are being incorporated earlier in the drug development pipeline – such as in early-phase trials,” said Dr. Su Youn Nam, CEO/CMO of GI Innovation. “We are excited to partner with Agilent, a global leader in diagnostics innovation, which gives us access to its genomic profiling capabilities in various tumor types. By utilizing Agilent’s innovative technology, we hope to better characterize patients who are likely to experience a favorable outcome with GI-101.”

This partnership with GI Innovation will help establish Agilent as a trusted clinical partner in Korea and promote NGS-based comprehensive biomarker profiling early on in clinical trials.

“Agilent actively seeks opportunities to partner with pharmaceutical companies worldwide to develop diagnostics for cancer therapy,” said Ryu Jae Soo, Agilent Korea Country General Manager. “We are pleased to support GI Innovation in this early-phase study to identify potential biomarkers for the novel compound GI-101, which will be our first partnership of this kind in Korea. GI Innovation’s commitment to incorporate biomarkers in early-phase trials to develop innovative medicine in areas of high unmet need aligns with our goal of enabling precision medicine through robust genomic profiling.”

The Agilent NGS panel tumor profiling assay that will be used enables genomic profiling of more than 500 cancer-related genes in a single assay with measurement of tumor mutational burden (TMB) including microsatellite instability-high (MSI-H), as well as variants characterization in tumor suppressor genes and genes involved in homologous recombinant repair (HRR), important emerging biomarkers in immuno-oncology.