GI Innovation is actively advancing efforts to expand the scope of its global Phase 2 clinical trial for its immuno-oncology candidate GI-101A. On January 30, GI Innovation announced in a public disclosure that it had submitted an amendment to the Investigational New Drug (IND) application for its Phase 1/2 clinical trial evaluating GI-101A as monotherapy and in combination with Keytruda (pembrolizumab) to the U.S. Food and Drug Administration (FDA). The amendment principally encompasses the adoption of the international nonproprietary name (INN) ‘efdelikofusp alfa,’ the introduction of a randomized study design for metastatic urothelial carcinoma, and the selection of Phase 2 target indications, including urothelial carcinoma, clear cell renal cell carcinoma, squamous cell non-small cell lung cancer, and microsatellite-stable (MSS) colorectal cancer. https://www.thebionews.net/news/articleView.html?idxno=21936

GI Innovation is actively advancing the development of a ‘next-generation allergy treatment’ optimized through the integration of artificial intelligence (AI) technologies. The company announced on January 20 that it has recently filed a patent application for a next-generation dual-fusion pipeline targeting atopic dermatitis. The next-generation dual-fusion allergy pipeline is engineered to concurrently inhibit the interleukin (IL)-4 and interleukin (IL)-13 signaling pathways, which are central mediators of allergic inflammation, while addressing the multifactorial pathophysiology of atopic dermatitis. In light of the competitive landscape, GI Innovation stated that it will refrain from disclosing additional details regarding other aspects of Dupixent's mechanism of action. https://www.thebionews.net/news/articleView.html?idxno=21625

On Tuesday, GI Innovation announced that it is ramping up development of a next-generation allergy treatment optimized using artificial intelligence (AI) technology. The company's novel dual fusion pipeline is designed to modulate the IL-4/IL-13 signaling pathway involved in allergic inflammation while simultaneously targeting the complex underlying causes of atopic dermatitis. Due to competitive considerations, GI Innovation has opted not to disclose specifics about mechanisms beyond that of Dupixent. The company initiated this pipeline over three years ago, beginning with the lead candidate GI-305, and has since made continuous structural improvements and functional validations. Notably, it has focused on enhancing antibody binding affinity, building on the same mechanism as Regeneron's blockbuster drug Dupixent, which generates annual sales of approximately $15 billion. https://en.news1.kr/lifestyle/5919552

GI Innovation is advancing the treatment of malignant brain tumors through an investigator-initiated clinical trial led by researchers at the Mayo Clinic, which ranked first in Newsweek's U.S. hospital rankings last year. The study is designed to assess the therapeutic potential of GI Innovation's bispecific Fc fusion protein, GI-102 (development code), administered either as monotherapy or in combination with MSD's immunotherapy Keytruda (pembrolizumab), in both neoadjuvant and adjuvant treatment settings. The clinical program targets high-grade malignant brain tumors, including glioblastoma and astrocytoma. https://www.thebionews.net/news/articleView.html?idxno=21401

This year's Nobel Prize in Physiology or Medicine was awarded to Professor Shimon Sakaguchi of Osaka University, in recognition of his groundbreaking discovery of regulatory T cells (Tregs), a finding that revolutionized the global paradigm of immune tolerance. Jang Myoung-ho, CEO of GI-Innovation and a former professor at the University of Osaka, who previously conducted research alongside Professor Sakaguchi, expressed deep emotion and admiration upon learning of the award. Over a decade ago, Jang co-authored a research paper with Sakaguchi [screenshot of the paper below] reflecting their shared contribution to the field of immunology. https://www.thebionews.net/news/articleView.html?idxno=18731

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 FDA’s fast track program is designed to speed the review of treatments for serious conditions with limited options. The designation allows for closer consultation with the agency, rolling data submissions and potential benefits such as priority review or accelerated approval, which can shorten the process to as little as six months. https://www.koreaherald.com/article/10585851?ref=naver

GI-Innovation, a Korean biotechnology company, reported that its next-generation cytokine-based immunotherapy candidate, GI-102, demonstrated complete remission (CR) as a monotherapy in a Phase 1 clinical trial. This represents the first public disclosure of interim data from the ongoing Phase 1b clinical trial evaluating the subcutaneous (SC) formulation of GI-102. The achievement of a single complete remission (CR) with a cytokine-based agent is a rare achievement and is anticipated to serve as a catalyst for advancing technology transfer negotiations with global pharmaceutical companies.The clinical trial is being conducted at the Mayo Clinic, a globally recognized medical institution in the United States. Notably, earlier this year, the Mayo Clinic was ranked first in the World's Best Hospitals 2025 list, published by the renowned U.S. weekly magazine Newsweek with the global research organization Statista.https://www.thebionews.net/news/articleView.html?idxno=17635​

The Korean biotechnology company GI Innovation has been added to the Morgan Stanley Capital International (MSCI) Korea Index, alongside Doosan Robotics and CJ CheilJedang. MSCI announced on August 7 (local time) that, following its regular review, a total of 17 stocks have been newly included in the KOREA INDEX. The index rebalancing (adjustment of constituent stocks) is scheduled to take place after the market closes on August 26. https://www.thebionews.net/news/articleView.html?idxno=17073

GI Innovation has secured a ‘substance patent’ in the U.S., following the earlier registration of a ‘high-content sialic acid patent,’ thereby affirming the innovativeness of ‘GI-301’ (lesigercept, Yuhan Corporation development code: YH35324) in both composition and quality. GI-301 is part of the company's pipeline of next-generation allergy treatment candidates. In particular, establishing patent protection in the U.S., the world's largest pharmaceutical market, has positioned GI-301 advantageously for global technology transfer to international companies. https://www.thebionews.net/news/articleView.html?idxno=16889

GI Innovation announced on July 28 that it has secured a U.S. material patent for the protein structure combination of its next-generation allergy treatment candidate substance, ‘GI-301’ (lesigercept, Yuhan Corporation development code: YH35324). The company stated that this patent is particularly significant as it secures the rights to the main ingredient of GI-301 itself, thereby establishing an intellectual property rights system capable of providing ‘dual’ protection of GI-301, both in terms of its ingredient composition and quality, complementing that high-content sialic acid patent registered in the U.S. last May. https://www.thebionews.net/news/articleView.html?idxno=16821

GI Innovation announced on July 22 the signing of a memorandum of understanding (MOU) with Aimed Bio, a company specializing in the development of antibody-drug conjugates (ADCs), to establish a clinical research collaboration focused on glioblastoma multiforme (GBM) treatment. This MOU aims to pursue ‘Accelerated Approval’ through clinical research on combination therapy involving GI Innovation’s immunotherapy candidate, ‘GI-102 (development code),’ for patients with relapsed GBM who have undergone radiosurgery or other treatments. GI-102 has already demonstrated anticancer activity in preclinical glioblastoma models. https://www.thebionews.net/news/articleView.html?idxno=16719

GI Innovation has reported promising early clinical outcomes from the combination therapy of its immunotherapy candidate ‘GI-102 (development code)’ and MSD (Merck, USA)’s immune checkpoint inhibitor ‘Keytruda’ in patients who were refractory or resistant to prior immunotherapy. As of July 6, the objective response rate (ORR) for the ‘GI-102 + Keytruda’ combination therapy reached 75% (3 out of 4 patients), with one patient achieving complete remission (CR). https://www.thebionews.net/news/articleView.html?idxno=16243