GI-102 / GI Innovation - LARVOL DELTA

Keynote-G08: An Open-label, Multicenter, Dose Escalation and Expansion Phase 1/2 Study of GI-102 (CD80/IL2v3) in advanced solid tumors (Part A and D of GII-102-P101) (ESMO 2025) - No abstract available

Clinical • Metastases • P1/2 data • Oncology • Solid Tumor • CD80

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

GI Innovation Selected for 2 National New Drug Development Projects [Google translation] (HIT News) - "GI Innovation announced on the 26th that it had been selected for two projects in the 2nd National New Drug Development Project in 2024 by the National Drug Development Fund...The projects selected this time are 'New Drug Clinical Development Phase 2 Clinical Trial' and 'New Drug-Based Expansion Research Leading Material Phase'. For the New Drug Clinical Development Phase 2 Clinical Trial, we will receive research support for two years in cooperation with Professor Seung-Tae Kim of...Samsung Seoul Hospital, with the goal of obtaining GI-102 technology transfer and accelerated approval....In addition, the next-generation multi-target macrophage regulator GI-128 was selected for the new drug-based expansion research lead substance project. This project will receive research support for two years with the goal of developing an optimized lead candidate substance and quickly entering the non-clinical stage and early technology transfer."

Financing • New P2 trial • Oncology • Solid Tumor

A Study to Evaluate the Safety and Therapeutic Activity of GI-102 As a Single Agent and in Combination with Conventional Anti-cancer Drugs, Pembrolizumab or Trastuzumab Deruxtecan(T-DXd) in Patients with Advanced Solid Tumors (KEYNOTE-G08) (clinicaltrials.gov) - P1/2 | N=358 | Recruiting | Sponsor: GI Innovation, Inc. | N=92 ➔ 358 | Trial completion date: Jun 2025 ➔ Apr 2027 | Trial primary completion date: Apr 2025 ➔ Nov 2025

Combination therapy • Enrollment change • Metastases • Trial completion date • Trial primary completion date • Breast Cancer • Colorectal Cancer • Cutaneous Melanoma • Genito-urinary Cancer • Hepatocellular Cancer • Hepatology • HER2 Breast Cancer • HER2 Negative Breast Cancer • Melanoma • Oncology • Ovarian Cancer • Renal Cell Carcinoma • Sarcoma • Skin Cancer • Soft Tissue Sarcoma • Solid Tumor • CD4 • CD8

GI Innovation-IDivene, Differentiating New Drug Development through Collaboration Using AI [Google translation] (BioTimes) - "Innovative pharmaceutical company GI Innovation Co., Ltd. announced on the 24th that it signed a memorandum of understanding (MOU) for artificial intelligence (AI) cooperation for differentiation in new drug development with AI performance prediction solution company IDivine Co., Ltd....Through this agreement, the two companies will focus on establishing an optimal clinical development strategy for GI Innovation's core anticancer pipelines, GI-102 and GI-108, and discovering new targets, utilizing Idivine's AI technology."

Licensing / partnership • Oncology • Solid Tumor

GI-102 Monotherapy Shows Strong Results in ESMO 2024 Interview [Google translation] (HIT News) - P1 | N=NA | "In our meetings, we shared phase 1 data for GI-102 as a monotherapy. Some attendees mistook the results for a combination therapy due to the strong anticancer activity we observed. GI-102 showed a partial response in 43% of melanoma patients who had previously failed immunotherapy....This result stands out when compared to combination therapies like Opdivo with RP1, which showed an ORR of 34%, and nivolumab with ipilimumab, which demonstrated an ORR of 39%....'We're also focused on securing accelerated approval for GI-102 from the US FDA, following our productive meetings at ESMO. We hope to bring positive news soon.'"

P1 data • Melanoma

GI Innovation Announces New Clinical Trial Collaboration and Supply Agreement to Evaluate GI-102 in Combination with KEYTRUDA (pembrolizumab) in Patients with Immunotherapy-Resistant Liver Cancer, Melanoma, and Renal Cell Carcinoma (Businesswire) - "The South Korean biotech company GI Innovation announced today that it has signed a clinical trial collaboration and supply agreement with MSD...to evaluate the combination of GI-102 and MSD’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab) in patients with immunotherapy-resistant liver cancer, melanoma, and renal cell carcinoma...The Phase 2 clinical trial including GI-102 in combination with KEYTRUDA will enroll patients with resistance or non-response to immuno-oncology treatments, leaving them with no further treatment options."

Licensing / partnership • Genito-urinary Cancer • Kidney Cancer • Liver Cancer • Melanoma • Oncology • Renal Cell Carcinoma • Skin Cancer • Solid Tumor

GI Innovation, which increased capital by 20 bi llion won, is likely to raise additional funds [Google translation] (Pharm E Daily) - "Nevertheless there is an analysis, that is important to keep an eye on it, as operating expenses are expected to decrease in the future and there is a possibility that technology transfer will be successful in the second half of the year...The company is currently pursuing a global technology transfer for 'GI-101A' and 'GI-102', which are currently under development as immune-oncology drugs....The company plan to submit a domestic phase 1 clinical trial plan (IND) for the 4th generation immunotherapy drug 'GI-108' this month."

Licensing / partnership • New P1 trial • Oncology • Solid Tumor

GI Innovation decides to issue 20 billion won worth of CB and CPS… First fundraising after listing [Google translation] (HIT News) - "GI Innovation announced on the 30th that it had decided to raise a total of KRW 20 billion through KRW 10 billion in convertible stocks (CPS) and KRW 10 billion in convertible bonds (CB). This is the first capital infusion since its listing in March 2023....The company plans to use the funds for the subcutaneous injection (SC) monoclinical clinical trials of the immunotherapy anticancer drugs 'GI-101A' and 'GI-102' and combination clinical trials with Enhertu and Keytruda, the metabolic anticancer drug 'GI-108'..."

Financing • Oncology • Sarcoma • Solid Tumor

GI Innovation, Registers Material Patent for Immune Anticancer Drugs 'GI-101A·GI-102' in China [Google translation] (HIT News) - "Innovative new drug development company GI Innovation...announced on the 3rd that the material patent for the immune anticancer drug 'GI-101A·GI-102' has been registered in China...Following the US, Europe, and Japan, the company has successfully registered a material patent for GI-101A/GI-102 in China, securing exclusive rights in major countries in the global biopharmaceutical market....'Since patent registration is proceeding smoothly in other countries where we have applied, such as Russia and Australia, we expect successful registration in other countries where the patent is currently in the review stage. This will be advantageous in future licensing agreement negotiations.'" "

Patent • Oncology • Solid Tumor

[KOSDAQ CEO Interview] GI Innovation President Jang Myeong-ho: "Immuno-oncology drug, following US FDA, completes Chinese material patent… technology transfer possible within the year" [Google translation] (Nate) - "President Jang expressed confidence in the technology transfer within the year...'We are discussing technology transfer for GI-101 and GI-102 with four of the top 10 global pharmaceutical companies.'....'We are also discussing with several domestic and foreign pharmaceutical companies about the new drug candidate GI-108, which is in the preclinical stage.'"

Licensing / partnership • Preclinical • Oncology • Solid Tumor

GI Innovation's cancer immunotherapy candidate 'GI-102' designated as orphan drug by FDA [Google translation] (HIT News) - "GI Innovation...announced on the 11th that it has received orphan drug (ODD) designation for advanced or metastatic sarcoma for its next-generation immunotherapy candidate 'GI-102' from the U.S. Food and Drug Administration (FDA)....Following the approval, the company is expected to gain more momentum in GI-102's global expansion."

Orphan drug • Oncology • Sarcoma • Solid Tumor

A first-in-human, phase 1/2a study of GI-102 (CD80-IL2v3) in patients with advanced or metastatic solid tumors: Initial results from dose escalation. (ASCO 2024) - P1/2 | "GI-102 was well tolerated up to dose of 0.45 mg/kg Q3W with meaningful monotherapy activity, regardless of previous ICB experience, in patients who failed on standard of care. The dose-escalation is currently ongoing to identify RP2D."

Clinical • Metastases • P1/2 data • Cutaneous Melanoma • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • CD8 • CD80 • IL2

GI Innovation announces clinical results of single-use 'GI-102' at 'ASCO' [Google translation] (Yakup Shinmoon) - P1/2a | N=92 | NCT05824975 | Sponsor: GI Innovation, Inc. | "GI Innovation announces clinical results of ‘GI-102’ monotherapy at ‘ASCO2024’ (poster session)...According to the abstract, an objective response was observed in 17.4% (4/23) of 23 patients (7 cutaneous melanoma, 4 non-small cell lung cancer, 3 ovarian cancer, etc.) who underwent tumor evaluation at least once after treatment...In addition, the overall response rate (ORR) and disease control rate (DCR) were 42.9% (3/7) and 85.7% (6), respectively, including 3 confirmed partial responses (cPRs) in patients with metastatic melanoma who had previously undergone ICB. It was /7)....In vivo studies combining GIC-102 and GI-101 demonstrated antitumor activity lasting up to 4 weeks and enhanced NK cell proliferation in vivo."

P1/2 data • Cutaneous Melanoma • Gynecologic Cancers • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Skin Cancer • Solid Tumor

GI Innovation speeds up development of immuno-oncology drug in SC formulation (Korea Biomedical Review) - "The company said Tuesday that it has applied for approval to change the IND (investigational new drug) application for the GI-102 phase 1/2a clinical trial to the Ministry of Food and Drug Safety (MFDS). It did so more than a year after the clinical trial was approved in February last year. Through this IND change, GI Innovation plans to change the clinical phase from phase 1/2a to phase 1/2 while expanding the expiration date of GI-102 from 24 months to 36 months. In particular, under the revised clinical design, GI Innovation will evaluate the safety and tolerability of the SC formulation monotherapy and the existing intravenous (IV) formulation monotherapy....If MFDS accepts the application for clinical approval, the company will conduct a five-year clinical trial for 340 patients with advanced/metastatic solid cancer at six domestic medical institutions..."

Clinical protocol • Solid Tumor

GI Innovation registers European substance patent for immunotherapy drugs ‘GI-101A·102’ [Google translation] (HIT News) - P1/2a | N=92 | NCT05824975 | Sponsor: GI Innovation, Inc. | "GI Innovation...announced on the 14th that material patents for immune anti-cancer drugs GI-101A and GI-102 (development code names) have been registered in Europe...the company explains that European patent registration for GI-101A and GI-102 means strong protection for all commercialization areas of the materials, and will greatly improve the technology's attractiveness in the global market....Meanwhile, clinical trials for both GI-101A (phase 1/2 clinical trial) and GI-102 (phase 1/2a clinical trial) are progressing smoothly. In particular, in the case of GI-102, partial responses (PRs) have been confirmed in five patients without serious toxicity so far in monotherapy dose-escalation clinical trials."

P1/2 data • Patent • Trial status • Oncology • Solid Tumor

GI Cell, GI Innovation to collaborate on cancer treatment development (Korea Biomedical Review) - "GI Cell, an affiliate of GI Innovation, has submitted an application to the Ministry of Food and Drug Safety for phase 1/2a clinical trials to evaluate the safety and efficacy of a combination therapy between GI Cell's allogeneic NK cell therapy, T.O.P. NK and GI-101A, in patients with recurrent and refractory solid tumors...,The companies plan to extend their collaboration to include clinical trials for a combination therapy involving T.O.P. NK and another drug, GI-102, in the future."

Licensing / partnership • New P1/2 trial • Oncology • Solid Tumor