GI Innovation said it would begin patient enrollment for its phase 1/2a clinical trial of GI-108, a fourth-generation metabolic immunotherapy.The company is collaborating with contract development and research organization (CDRO) MediRama to accelerate the clinical development of its pipeline, following the progress of its other immunotherapy candidates GI-101A and GI-102.https://www.koreabiomed.com/news/articleView.html?idxno=26845

GI Innovation announced on February 3 that it has successfully registered the material patent for its allergy treatment candidate substance, 'GI-301 (development code name, Yuhan Corporation development code name YH35324),' in Europe. This registration ensures that the material patent for GI-301 is protected until 2039, with the potential for an extension until 2044 once the drug is approved. The company views this registration decision as an important milestone in securing a strong foothold in the European allergy treatment market. https://www.thebionews.net/news/articleView.html?idxno=12519

Innovation (KQ:358570) announced that it signed a Memorandum of Understanding (MOU) with LaNova Medicines (LaNova) for the development of GI-102 and ADC pancreatic cancer combination therapy.This MOU was held on January 15th, local time, during JP Morgan Healthcare Conference (San Francisco, USA). The two companies have been conducting combination therapy study of the immuno-oncology drug GI-102 and ADC LM-302 targeting Claudin18.2 and recently observed excellent anticancer activity in a preclinical pancreatic cancer model. https://finance.yahoo.com/news/gi-innovation-lanova-medicines-signs-130000201.html?guccounter=1

GI Innovation announced on January 16 that its next-generation immunotherapy candidate, GI-102, has been designated as an orphan drug during its development stage.This orphan drug designation applies to the treatment of unresectable or metastatic melanoma, granted by the Ministry of Food and Drug Safety on January 15. The official announcement will be made on the official website and other platforms.https://www.thebionews.net/news/articleView.html?idxno=12177

GI Innovation, a Korean biotech company, announced its participation in the 2025 J.P. Morgan Healthcare Conference from Jan. 13-16 in San Francisco, Calif., U.S. The company plans to engage in discussions regarding the technology transfer of its flagship pipelines, GI-101A and GI-102, which are T cell-based therapies that aim to treat hematologic cancers and solid tumors. T cell-based therapies, such as T cell engagers and CAR-T treatments, represent a groundbreaking modality in the $120 billion global hematologic cancer market.https://www.koreabiomed.com/news/articleView.html?idxno=26259

GI Innovation announced on Dec. 23 the successful completion of the first patient dosing in the Phase 1 clinical trial of the subcutaneous (SC) formulation of its immuno-oncology drug "GI-102." This milestone marks the first instance of SC administration for an independently developed immuno-oncology drug in South Korea, a significant step forward in cancer treatment innovation. The clinical trial for the GI-102 subcutaneous injection is being conducted at approximately 14 medical institutions, including renowned global institutions such as the Mayo Clinic, Cleveland Clinic, and Memorial Sloan Kettering Cancer Center. Domestically, the trial is taking place at leading institutions like Samsung Medical Center, Asan Medical Center, Seoul National University Hospital, Yonsei University Severance Hospital, and St. Vincent's Hospital. https://www.businesskorea.co.kr/news/articleView.html?idxno=232421

BG Rhee walks us through GI Innovation's programs and describes what he would like to see improve about Korea's biotech sector, including an idea to create BIO Asia. https://www.biotechtv.com/post/gi-innovation-november-26-2024

GI Innovation said it has signed a memorandum of understanding (MOU) with i-Divine, a local company specializing in AI-based performance prediction solutions, to enhance clinical development strategies for its new drug pipelines through artificial intelligence (AI) collaboration. https://www.koreabiomed.com/news/articleView.html?idxno=25212

The 2024 ESMO Annual Congress, held from September 13th to 17th in Barcelona, Spain, showcased key advancements in cancer treatments. GI Innovation, focused on next-generation immuno-oncology therapies, shared their experience at the event and discussed their evolving pipeline.GI Innovation is known for developing protein-based drugs through their GI-SMART platform, targeting immuno-oncology, allergies, and non-alcoholic steatohepatitis (NASH). Their pipeline includes several drug candidates in immuno-oncology, including GI-101, GI-102, GI-108, and GI-10N.http://www.hitnews.co.kr/news/articleView.html?idxno=57820

GI Innovation said it has signed a memorandum of understanding (MOU) with i-Divine, a local company specializing in AI-based performance prediction solutions, to enhance clinical development strategies for its new drug pipelines through artificial intelligence (AI) collaboration. Through this partnership, the two companies will focus on optimizing clinical development strategies for GI Innovation’s key cancer immunotherapy pipelines, GI-102 and GI-108, using i-Divine’s advanced AI technology.https://www.koreabiomed.com/news/articleView.html?idxno=25212

GI Innovation has confirmed the application for orphan drug designation (ODD) in the U.S. for its immunotherapy candidate, 'GI-102 (development code name).' The application targets 'refractory or resistant melanoma to immunotherapy' as the lead indication (or primary indication), aiming for expedited commercialization. This marks the second application following the orphan drug designation granted by the FDA on June 10 for 'metastatic sarcoma'. On September 2, GI Innovation revealed that it applied for orphan drug designation for GI-102 with the U.S. Food and Drug Administration (FDA) on July 29, targeting melanoma stage 2B and 3~4. The company plans to conduct a phase 2 clinical trial to test the combination therapy of GI-102 and 'Keytruda (pembrolizumab)' with the goal of securing this indication. A supply agreement for Keytruda has already been signed with the multinational pharmaceutical company MSD(Merck). https://www.thebionews.net/news/articleView.html?idxno=8365

South Korean biotech company GI Innovation announced Monday a new partnership with Merck Sharp & Dohme, a subsidiary of pharmaceutical company Merck & Co., to test its drug GI-102 in combination with MSD’s anti-PD-1 therapy Keytruda (pembrolizumab) for treating patients with immunotherapy-resistant liver cancer, melanoma and renal cell carcinoma. https://news.koreaherald.com/view.php?ud=20240826050479&md=20240829003341_BL