GI Innovation Advances Immunotherapy Pipeline with GI-101 and GI-102

GI Innovation, a biotechnology company focused on next-generation immunotherapies, is making significant strides in the development of its pipeline of fusion protein-based drugs. The company’s core programs include GI-101/GI-102 immunotherapies, alongside GI-301 for allergy treatment and GI-108 for metabolic immune treatment. Recent developments highlight progress in clinical trials and strategic partnerships, positioning GI Innovation for potential growth in the competitive immunotherapy landscape.

GI-101: Targeting CTLA-4 with a Novel Fusion Protein

GI-101 is a bispecific fusion protein designed to enhance anti-tumor activity. It combines CD80 and an interleukin-2 (IL-2) variant to target cytotoxic T-lymphocyte-associated protein 4 (CTLA4) and preferentially bind to the IL-2Rβ subunit. Preclinical studies have demonstrated strong anti-tumor efficacy, stimulating the proliferation of CD8+ T and NK cells [3].

A Phase 1/2 clinical trial is currently underway to evaluate the safety, tolerability, pharmacokinetics, and therapeutic activity of GI-101, both as a single agent and in combination with pembrolizumab, lenvatinib, or local radiotherapy. The study is evaluating GI-101/GI-101A across a range of advanced and/or metastatic solid tumors [2]. Regulatory approval for changes to the clinical trial plan has been secured from both the U.S. Food and Drug Administration and the Korean Ministry of Food and Drug Safety [3].

GI-102: Promising Results in Advanced Cancer

GI-102 has recently garnered attention following reports of a partial response in a terminal cancer patient in their 70s [4]. This positive outcome has spurred further investigation into its potential. Clinical trial plans are progressing, with approval received for a Phase 1/2 trial in Australia to assess GI-102 monotherapy and combinations with existing cancer treatments, including pembrolizumab and trastuzumab deruxtecan [4]. A clinical trial plan to evaluate aging-related biomarkers of GI-102 therapy in adults with lymphopenia and cancer survivors has been approved in Korea [4].

GI-SMART™ Platform and Future Outlook

GI Innovation utilizes its proprietary GI-SMART™ platform, a high-throughput screening system, to efficiently discover and develop lead product candidates and cell lines [1]. The company is actively exploring technology transfers, including those related to GI-102, as demonstrated by its participation in the J.P. Morgan Healthcare Conference [4].

As of February 26, 2026, GI Innovation’s stock showed a slight increase of 3.13%, closing at 15,290 KRW. The company continues to pursue multiple clinical trials and explore strategic partnerships, indicating a commitment to advancing its immunotherapy pipeline and addressing unmet medical needs.