09 November 2020 | News
Collaboration for Biomarker Profiling in Phase 1/2 Study of Cancer Immunotherapy GI-101
Image credit- Agilent
Agilent Technologies Inc. has announced the signing of a memorandum of understanding (MOU) with GI Innovation (GII), a Korean clinical-stage biopharmaceutical company. The MOU establishes a framework in which the two companies will enter into a strategic partnership to explore potential genomic biomarkers of the tumor microenvironment in an early-phase trial of the investigational compound GI-101.
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.