GI-102 / GI Innovation - LARVOL DELTA

GI-102 Alone or With Pembrolizumab Before Surgery for Treatment of Recurrent or Progressive IDH Wildtype Glioblastoma and IDH Mutated Grade 4 Astrocytoma (clinicaltrials.gov) - P2 | N=36 | Recruiting | Sponsor: Mayo Clinic | Suspended ➔ Recruiting

Enrollment open • Anaplastic Astrocytoma • Astrocytoma • Brain Cancer • Glioblastoma • Gliosarcoma • Oncology • Sarcoma • Solid Tumor

Prediction of pharmacokinetics and pharmacodynamics profile for a fixed dosing and body weight-based dosing of GI-102 based on cell-level pharmacodynamics-mediated drug disposition model in patients with advanced or metastatic solid tumors (AACR 2026) - "In addition, simulations for fixed-dose regimen of 10, 20, and 30 mg showed increased immune cell proliferation, largely comparable to corresponding weight-based doses of 0.12, 0.24, and 0.35 mg/kg, respectively. Our modeling and simulation provides preliminary prediction of PD effect at tested doses and fixed-dose regimens, serving as reference for determining optimal dose and dosing regimen."

Clinical • First-in-human • Metastases • PK/PD data • Oncology • Solid Tumor • CD80 • IL2

GI Innovation said on the 24th that it received approval from the Ministery of Food and Drug Safety for a phase 2 clinical trial to evaluate the combination therapy of the immuno-oncology candidate 'GI-102' and 'Keytruda' in patients with metastatic melanoma (skin cancer) (Chosun Biz) - "The trial will target treatment-naive patients with metastatic melanoma and compare, in a randomized design, the standard-of-care monotherapy of Merck (MSD)'s immunotherapy Keytruda with the combination therapy of GI-102. Following U.S. Food and Drug Administration (FDA) approval, approval of the phase 2 plan in Korea is expected to accelerate the global phase 2 development....The trial will be conducted at major global medical institutions, including Mayo Clinic, Cleveland Clinic, MD Anderson Cancer Center, Memorial Sloan Kettering Cancer Center, Samsung Medical Center, and Asan Medical Center."

New P2 trial • Melanoma

GI Innovation announced on 19th that it has entered into a clinical supply agreement with Johnson & Johnson to evaluate a combination therapy in patients with metastatic castration-resistant prostate cancer (mCRPC) in a phase 1b clinical trial (PRNewswire) - "This trial aims to evaluate the combination of GI Innovation's immuno-oncology agent GI-102 with pasritamig (KLK2-CD3), a first-in-class bispecific T-cell engager....Under the terms of the clinical supply agreement, Johnson & Johnson will provide pasritamig to GI Innovation, who will be the sponsor of the Phase 1b clinical trial. The study will be conducted in both Korea and the United States."

Commercial • New P1 trial • Castration-Resistant Prostate Cancer

The intravenous (IV) formulation of GI-102 as monotherapy demonstrated an objective response rate (ORR) of 25% and a disease control rate (DCR) exceeding 80% in a Phase 1 clinical study involving patients with melanoma patients. (BioNews) - "'In the case of GI-102, no DLTs were observed and no deaths were reported.'"

P1 data • Melanoma

GI-102 Alone or With Pembrolizumab Before Surgery for Treatment of Recurrent or Progressive IDH Wildtype Glioblastoma and IDH Mutated Grade 4 Astrocytoma (clinicaltrials.gov) - P2 | N=36 | Suspended | Sponsor: Mayo Clinic | Not yet recruiting ➔ Suspended

Trial suspension • Anaplastic Astrocytoma • Astrocytoma • Brain Cancer • Glioblastoma • Gliosarcoma • Oncology • Sarcoma • Solid Tumor

GIANTS-1: A Study to Evaluate the Effects of the Combination of GI-102 With GIB-7 on Biomarkers of Aging in Healthy Adults and Cancer Survivors (clinicaltrials.gov) - P2 | N=15 | Recruiting | Sponsor: GI Innovation, Inc.

Biomarker • New P2 trial • Oncology

GI-102 Alone or in Combination With Pembrolizumab Before Surgery for the Treatment of Recurrent or Progressive IDH Wildtype Glioblastoma and IDH Mutated Grade 4 Astrocytoma (clinicaltrials.gov) - P2 | N=36 | Not yet recruiting | Sponsor: Mayo Clinic

New P2 trial • Anaplastic Astrocytoma • Astrocytoma • Brain Cancer • Glioblastoma • Gliosarcoma • Oncology • Sarcoma • Solid Tumor

Trial in progress: A Phase 2a Study of GI-102 (CD80/IL2v3) as a consolidation therapy in patients with relapsed/refractory diffuse large B-cell lymphoma following anti-CD19 chimeric antigen receptor T-cell therapy (CARNATION trial) (ASH 2025) - P1/2 | "By evaluating GI-102 as a consolidation therapy, we aim to address the critical need for improvedlong-term outcomes in this challenging patient population. The results of this trial may pave the way fornew strategies to optimize CAR T therapy in hematologic malignancies."

CAR T-Cell Therapy • Clinical • IO biomarker • P2a data • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Large B Cell Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Solid Tumor • CD8 • CD80

Novel immunocytokine CD80/IL2v synergizes with α-PD-1 for treatment of preclinical murine glioblastoma models (SNO 2025) - "GI-101 and GI-102 are novel CD80/IL-2v immunocytokines designed to selectively activate immune cells by targeting IL-2Rβγ while minimizing IL-2Rα binding. Furthermore, through immune depletion strategies, we determined that both CD4+ T cells and CD8+ T cells were the critical immune cell type required for these therapeutic effects. These findings imply that anti-PD-1 checkpoint blockade supplemented with fusion protein that includes CD80, and engineered IL-2 cytokine could be effective in treating human GBM."

Preclinical • Brain Cancer • Glioblastoma • Glioma • Solid Tumor • CD4 • CD8 • CD80 • IL2 • TRB

Lee explains GI Innovation’s GI-102 CAR-T persistence study to an ASH 2025 attendee during the poster session. (Korea Biomedical Review) - "He explained that the team first ran a Daudi-Luc lymphoma xenograft model in which CAR-T cells alone produced tumor regression between day 15 and day 21, but many animals experienced tumor regrowth by day 32. When GI-102 was added to CAR-T cells, he said the combination maintained tumor clearance even at day 32, and, importantly, showed durable memory function when the animals were re-challenged with new tumors on day 56."

Preclinical • Diffuse Large B Cell Lymphoma

[ASH 2025] GI Innovation examines GI-102 to revive CAR-T cell persistence in relapsed or refractory DLBCL (Korea Biomedical Review) - "The study features a safety run-in evaluating 0.12 and 0.24 mg/kg doses using a 3+3 design before moving into dose expansion. According to the poster, the primary objective is to measure CAR-T cell pharmacokinetics over time after GI-102 administration, while secondary endpoints include overall response rates, duration of response, progression-free survival, and overall survival. The protocol also incorporates immune monitoring through flow cytometry, circulating tumor DNA, single-cell RNA sequencing, and T-cell receptor repertoire analysis."

Clinical protocol • Diffuse Large B Cell Lymphoma

Novel immunocytokine CD80/IL2v synergizes with α-PD-1 for treatment of preclinical murine glioblastoma models (WFNOS 2025) - "GI-101 and GI-102 are novel CD80/IL-2v immunocytokines designed to selectively activate immune cells by targeting IL-2Rβγ while minimizing IL-2Rα binding. Furthermore, through immune depletion strategies, we determined that both CD4+ T cells and CD8+ T cells were the critical immune cell type required for these therapeutic effects. These findings imply that anti-PD-1 checkpoint blockade supplemented with fusion protein that includes CD80, and engineered IL-2 cytokine could be effective in treating human GBM."

Preclinical • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Oncology • Solid Tumor • CD4 • CD8 • CD80 • IL2 • TRB

Keynote-G08: An open-label, multicenter, dose escalation and expansion phase I/II study of GI-102 (CD80/IL2v3) in advanced solid tumors (part A and D of GII-102-P101) (ESMO 2025) - P1/2 | "Clinical trial identification NCT05824975. Early data from combination with pembrolizumab suggest encouraging activity in IO-refractory or resistant tumors. The study is ongoing with continued enrollment."

Clinical • Metastases • P1/2 data • Lung Cancer • Melanoma • Merkel Cell Carcinoma • Non Small Cell Lung Cancer • Non-melanoma Skin Cancer • Oncology • Ovarian Cancer • Renal Cell Carcinoma • Skin Cancer • Solid Tumor • CD8 • CD80 • IL2

[ESMO 2025] GI Innovation’s IL-2 therapy shows tumor response in ICB-resistant cancers (Korea Biomedical Review) - "According to interim results from the phase 1/2 KEYNOTE-G08 (GII-102-P101) trial presented at the European Society for Medical Oncology (ESMO) Annual Congress 2025 in Berlin, Germany, from Friday to Tuesday, GI-102 achieved an objective response rate (ORR) of 18 percent and a disease control rate (DCR) of 64 percent in monotherapy. In combination therapy with pembrolizumab (Keytruda), it achieved an ORR of 40 percent and a DCR of 70 percent."

P1/2 data • Solid Tumor

Korean biotech company GI Innovation said Monday it has received Fast Track Designation from the US Food and Drug Administration for GI-102, its next-generation immuno-oncology therapy targeting advanced or metastatic melanoma. (The Investor) - "GI-102, delivered as a subcutaneous injection, showed encouraging results in a Phase 1 trial involving 14 patients who had previously been treated with other immunotherapies. The study reported an objective response rate of 25 percent and a disease control rate of 83 percent, both significantly higher than the approved standard therapy Opdualag."

Fast track • Melanoma

GI Innovation and AimedBio collaborate on glioblastoma treatment research in South Korea (Chosun Biz) - "GI Innovation announced on the 22nd that it has signed a memorandum of understanding (MOU) with AimedBio, a company specializing in the development of antibody-drug conjugates (ADCs), to collaborate on clinical research for treating glioblastoma (GBM). The MOU aims to obtain accelerated approval through clinical research of the combination therapy using GI Innovation's immune anticancer drug GI-102, targeting patients with recurrent glioblastoma who have undergone radiation surgery or treatment."

Licensing / partnership • Glioblastoma

GI Innovation targets FDA approval for melanoma immunotherapy by 2028 (Chosun Biz) - P1/2 | N=358 | KEYNOTE-G08 (NCT05824975) | Sponsor: GI Innovation, Inc. | "During an online briefing on the 30th, CEO Jang noted that in a Phase 2 clinical trial using the immuno-oncology candidate 'GI-102' in combination with Merck's (MSD) immuno-oncology drug 'Keytruda' (active ingredient pembrolizumab), they confirmed a more than 30% reduction in cancer cells of four patients with immune-oncology resistant or refractory cancer (kidney cancer and melanoma) and announced this plan....GI Innovation sets sights on expedited FDA endorsement for cutting-edge melanoma treatment by 2028."

FDA approval • P1/2 data • Kidney Cancer • Melanoma

GI Innovation and GI Biome Advance to the Semi-finals of XPRIZE Healthspan with Anti-Aging Potential of GI-102 and GIB-7 Combination Therapy (PRNewswire) - "Clinical studies have shown that GI-102 potently activates CD8+ T cells and NK cells at high doses, allowing those immune cells to safely attack a range of tumor types including melanoma, kidney, lung and bladder cancers. However, at a low dose, it selectively expands and activates NK cells, which are critical for clearing senescent cells and cellular debris, playing a vital role in delaying aging and maintaining physiological functions. Based on this mechanism, GI Innovation is pursuing the use of low-dose GI-102 as an NK cell enhancer."

Clinical • Bladder Cancer • Lung Cancer • Melanoma • Renal Cell Carcinoma

GI Innovation, Approval of Change in Clinical Trial Plan [Google translation] (HIT News) - "The company received approval from the US Food and Drug Administration for a change in the Phase 1/2 clinical trial plan to evaluate the safety, tolerability, pharmacokinetics, and antitumor efficacy of GI-102 monotherapy and combination therapy with existing anticancer treatment or pembrolizumab or trastuzumab deruxtecan. The reasons for the change request are the addition of a dosage cohort for Part B (subcutaneous administration) (0.45 mg/kg, 0.65 mg/kg) and a change in the concentration of the GI-102 clinical trial drug (2 mg/mL → 8 mg/mL)."

Clinical protocol • Solid Tumor

GI Innovation-Lanova Medicine, MOU for Combination Therapy for Pancreatic Cancer [Google translation] (HIT News) - "GI Innovation...signed a business agreement (MOU) with LaNova Medicines for research and development of a combination therapy of the immunotherapy drug 'GI-102' and the antibody-drug conjugate (ADC) 'LM-302' for the treatment of pancreatic cancer...The two companies have been conducting a combination therapy study of GI-102 and LM-302 targeting Claudin18.2, and recently emphasized that they confirmed high anticancer efficacy in a preclinical model of pancreatic cancer....Through this agreement, the two companies plan to begin clinical development targeting patients with terminal pancreatic cancer."

Commercial • Pancreatic Cancer

GI Innovation, Immune Oncology Drug 'GI-102' Designated as Orphan Drug by Ministry of Food and Drug Safety [Google translation] (BioTimes) - "GI Innovation Co., Ltd...announced on the 16th that its next-generation immune anticancer drug 'GI-102' was designated as an orphan drug in the development stage. This orphan drug designation targets the treatment of inoperable or metastatic melanoma, and was designated as an orphan drug in the development stage by the Ministry of Food and Drug Safety on the 15th..."

Orphan drug • Melanoma

GI Innovation "Participating in US JPM to Promote Technology Transfers including GI-102" [Google translation] (Hankyung) - "GI Innovation will be participating in the JP Morgan Healthcare Conference held in San Francisco, USA from the 13th to the 16th (local time)....At this event, GI Innovation will discuss the transfer of blood cancer technology through the combination of T cell-based treatment with the company's main pipeline 'GI-101A/GI-102', and solid cancer technology transfer following the acquisition of clinical results for the subcutaneous injection (SC) formulation."

Commercial • Hematological Malignancies • Solid Tumor

GI Innovation decides to increase capital by allocating 80 billion won to shareholders [Google translation] (Hankyung) - "GI Innovation is conducting a paid-in capital increase with shareholder allocation of 80 billion won...The new share allocation base date is February 12, 2025, the listing date is April 10, 2025, and Korea Investment & Securities will be the lead manager for the paid-in capital increase....The company plans to use the raised funds for Korean/US phase 1/2 clinical trials of immunotherapy drugs GI-101A and GI-102, clinical trials of metabolism-modulating anticancer drug GI-108, R&D of new pipelines such as GI-305, GI-213, and GI-128 other operating funds, etc."

Financing • Solid Tumor

GI Innovation completes 1st patient dosing of subcutaneous immunotherapy potentially for melanoma (Korea Biomedical Review) - "The company said this marks the first time a Korean firm has initiated SC administration for an immune-oncology drug, following MSD’s SC version of Keytruda (pembrolizumab), which pairs Merck’s anti-PD-1 therapy with Alteogen’s hyaluronidase variant, berahyaluronidase alfa....The phase 1 trial is being conducted at 14 medical institutions in Korea and the United States, including Mayo Clinic, Cleveland Clinic, Memorial Sloan Kettering Cancer Center, Samsung Medical Center, and Seoul National University Hospital....Jang Myung-ho, chief scientific officer at GI Innovation, noted that the phase 1 trial is expected to conclude by February 2025."

Trial status • Melanoma