GI Innovation Receives US FDA Approval for Phase 1 and 2 Clinical Trials of Immuno-Oncology Drug

Simultaneous Clinical Trials in Korea and the United States Starting This Month

[Asia Economy Reporter Kim Ji-hee] GI Innovation announced on the 15th that it received approval from the U.S. Food and Drug Administration (FDA) on the 12th for the clinical trial plan (IND) of the immuno-oncology drug GI-101 for Phase 1/2 trials. Having already obtained IND approval for GI-101 from the Ministry of Food and Drug Safety in April, the company plans to conduct simultaneous clinical trials in the U.S. and Korea starting this month.

Despite being in the early stages, the GI-101 clinical trial will be conducted on approximately 400 patients with 12 types of solid tumors. Specifically, it consists of four parts: ▲GI-101 monotherapy ▲combination therapy with MSD's Keytruda (including combination cohorts for seven cancer types) ▲combination therapy with Lenvima, a multi-kinase inhibitor including VEGFR ▲combination therapy with radiotherapy. Among these, the combination therapy part with MSD's Keytruda includes free provision of Keytruda for 200 patients from MSD.

Notably, GI Innovation's clinical design differs from conventional Phase 1 trials that only confirm drug safety. It is designed as a ‘seamless’ protocol combining Phase 1 and 2 to simultaneously conduct monotherapy and combination therapy, a ‘basket’ design evaluating various cancer types, and an ‘adaptive’ design expanding to cancer types showing good drug response.

Yoon Nari, director who led the clinical approval, stated, “This approval is significant as it recognizes our technological capability in developing bispecific fusion proteins, which are known to be difficult due to their complex structure. The clinical trial was designed focusing on cancer types expected to show the best anti-cancer activity after numerous discussions with MSD Merck, a global leader in the oncology market. We also expect great results as we will jointly analyze data with MSD after the trial begins, actively utilizing MSD’s know-how in immuno-oncology drug development.”

To conduct this large-scale clinical trial, GI Innovation recently completed a pre-IPO (pre-initial public offering) investment round raising approximately 160 billion KRW. Preparing for a KOSDAQ listing in the second half of the year, GI Innovation secured 45 billion KRW in strategic investments (SI) from SK and Genexine following Yuhan Corporation and iMarket Korea, and 115.5 billion KRW in financial investments (FI) from NH Investment & Securities, DS Asset Management, Brain Asset Management, Anda Asset Management, Regainvestment, Cloud & K-Clavis, and AJU IB.

Through this investment, GI Innovation aims to accelerate global clinical expansion and new pipeline development. The company plans to focus on simultaneous Phase 1/2 trials of GI-101 in the U.S. and Korea, as well as the development of new immuno-oncology bispecific fusion proteins, antibody drugs, and substances for non-alcoholic steatohepatitis (NASH).

Jang Myung-ho, CEO of GI Innovation, said, “Ahead of the second half listing, we conducted the pre-IPO to solidify global clinical trials of our existing pipelines and build new pipelines. We will do our best to achieve successful global GI-101 immuno-oncology trials and additional technology transfer outcomes.”

This content was produced with the assistance of AI translation services.