GI Innovation announced on the 10th that it has received approval from the Ministry of Food and Drug Safety (MFDS) of South Korea to amend the Investigational New Drug (IND) application for a Phase 1/2a clinical trial of 'GI-108,' a bispecific fusion protein candidate. The actual event date is the approval date of July 10, 2026.

Scope of Application and Clinical Structure This amendment applies to the ongoing monotherapy clinical trial of GI-108 in patients with advanced or metastatic solid tumors. It is an open-label, multi-center Phase 1/2a trial being conducted at Yonsei University Severance Hospital, Samsung Medical Center, and Seoul Asan Medical Center, evaluating safety, tolerability, pharmacokinetics (PK), and anti-tumor efficacy.

Key Changes: Patient Enrollment Expansion and Introduction of Adaptive Design The company adjusted the number of enrollees by adding cohorts during the dose escalation phase and expanding supplementary cohorts. It also incorporated adaptive design elements enabling a step-up dosing strategy. The revised target number of trial participants is up to 102, and the trial is expected to run for approximately three years, concluding on December 11, 2029.

Evaluation Direction for GI-108 GI-108 is an anti-CD73-IgG4 Fc-IL-2v bispecific fusion protein, a pipeline asset being co-developed with Medirama. During the dose escalation phase, the trial will determine the maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) and evaluate safety. In the dose expansion phase, anti-tumor activity will be evaluated primarily based on the objective response rate (ORR).

Investment Considerations The company noted that the statistical probability of an investigational drug receiving final marketing approval is known to be approximately 10%. It added that if results during the clinical trial and product approval process fall short of expectations, commercialization plans may be revised or discontinued. The company urged investors to carefully consider their investments by comprehensively reviewing the investment risks disclosed through periodic filings and business reports.