GI-108 / GI Innovation - LARVOL DELTA

A Study of GI-108, an Anti-CD73-IgG4 Fc-IL-2v Bispecific Fusion Protein, as Monotherapy in Patients With Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1/2 | N=76 | Recruiting | Sponsor: GI Innovation, Inc.

Monotherapy • New P1/2 trial • Genito-urinary Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

GI Innovation wins US patent for dual-action IL-2 therapy targeting cold tumors (Korea Biomedical Review) - "GI Innovation has secured U.S. patent protection for GI-108, its fourth-generation immunocytokine that targets CD73-driven tumors, where adenosine buildup suppresses immune responses and undercuts immunotherapy. The company said Wednesday it received a Notice of Allowance from the United States Patent and Trademark Office (USPTO), locking in exclusive rights to the drug’s bispecific fusion structure and mechanism of action....GI-108 is a bispecific fusion protein combining a CD73-targeting antibody, which blocks adenosine-mediated immune evasion, with a modified IL-2 variant that selectively activates CD8+ T cells, or cytotoxic lymphocytes."

Patent • Oncology

GI Innovation, 4th generation metabolic immune anticancer drug 'GI-108' published in the Journal of the American Society for Immuno-Oncology [Google translation] (BioTimes) - "GI Innovation Co., Ltd. announced on the 14th that a paper on the 4th generation metabolic immunotherapy cancer drug GI-108 was published in the Journal for ImmunoTherapy of Cancer (JITC), an academic journal of the Society for Immuno-Oncology (SITC)....According to the paper, in an experimental model simulating the tumor microenvironment, GI-108 showed CD8+ T cell activation about 8.6 times higher than AstraZeneca’s competing drug, Oleculumab. In particular, in a human triple-negative breast cancer model, which is a 'cold tumor,' GI-108 monotherapy confirmed superior anticancer activity compared to Keytruda, a third-generation immunotherapy drug with the world’s best-selling sales of 43 trillion won."

Preclinical • Oncology • Solid Tumor

GI Innovation, 4th generation metabolic immunotherapy cancer drug GI-108 clinical trial begins with ’complete remission in preclinical trials’ [Google translation] (BioTimes) - "GI Innovation Co., Ltd...announced on the 6th that patient registration for the phase 1/2a clinical trial of its 4th generation metabolic immunotherapy drug GI-108 has begun. The company plans to accelerate the clinical development of its follow-up pipeline following the immunotherapy drugs GI-101A and GI-102 in cooperation with MediRama, a clinical development research organization (CDRO)."

Trial status • Non Small Cell Lung Cancer • Pancreatic Cancer • Renal Cell Carcinoma

GI Innovation, Obtains Approval for Phase 1/2a of ’GI-108’, an Anticancer Drug for Metabolism [Google translation] (News1 Korea) - "According to industry sources on the 13th, GI Innovation recently received approval from the Ministry of Food and Drug Safety for the phase 1/2a clinical trial of its next-generation metabolic immunotherapy candidate, 'GI-108'...This clinical trial is a study to evaluate the efficacy and safety of GI-108 monotherapy in patients with advanced or metastatic solid tumors. It will be conducted in an open, multi-center, dose-escalation/dose-expansion manner. It is scheduled to be conducted at domestic medical institutions including Severance Hospital....In this clinical trial, GI Innovation plans to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (PR2D) of GI-108 monotherapy through the dose escalation phase. The dose expansion phase will evaluate the level of antitumor activity of GI-108."

New P1/2 trial • Oncology • Solid Tumor

A first-in-human, open-label, multicenter, phase 1/2a, dose-escalation and expansion study of GI-108, a novel immunocytokine combining anti-CD73-IL2v, in patients with metastatic solid tumors (SITC 2024) - "Preclinical studies have shown that GI-108 effectively reinvigorated CD8+ T cells even in the presence of AMP, unlike oleclumab.1 In Cynomolgus monkeys, intravenous administration of GI-108 resulted in robust increase of total lymphocytes and CD8+ T cells without significant toxicities. The primary objective of this study is to assess safety, and tolerability of GI-108 to define the MTD and/or RP2D in the dose escalation phase and to assess the anti-tumor activity of GI-108 in the dose expansion phase. Results This study is currently enrolling patients with advanced/metastatic solid tumors."

Clinical • Metastases • P1/2 data • Gastric Cancer • Oncology • Pancreatic Cancer • Solid Tumor • CD8 • NT5E

[SITC 2024] GI Innovation, 2 research results including 'GI-108' solid cancer clinical design, "announced at SITC" [Google translation] (eDaily) - "GI Innovation will disclose the mechanism of action and clinical design of GI-108, which is scheduled to proceed with phase 1/2a clinical trials for solid tumors, at the Society for Immuno-Oncology Conference (SITC 2024)...The clinical trial targets patients with advanced or metastatic solid cancer. The main clinical objectives are to evaluate the safety, tolerability, pharmacodynamics, and antitumor effects of GI-108 monotherapy....In addition, GI Innovation plans to present the preclinical study results of GI-101A in a lymphoma model as a poster."

Clinical protocol • Preclinical • Hematological Malignancies • Lymphoma • Oncology • Solid Tumor

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 Innovation, 'GI-108' monotherapy clinical phase 1/2a IND approval application [Google translation] (Yakup Shinmoon) - "On the 12th, GI Innovation applied to the Ministry of Food and Drug Safety for approval of a phase 1/2a clinical trial plan to evaluate the safety, tolerability, pharmacokinetics, and antitumor efficacy of GI-108 monotherapy in subjects with advanced or metastatic solid tumors...the clinical trial institution (target number of subjects: 60-80) has not been determined yet....In this clinical trial, the company plans to define the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of GI-108 monotherapy and evaluate the safety and tolerability (dose escalation phase) and evaluate the antitumor activity of GI-108 monotherapy (dose expansion phase)."

New P1/2 trial • Oncology • 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

[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