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

GI Innovation has unveiled the latest research data on 'GI-102' and 'GI-101A', which are immunotherapy candidates being developed as best-in-class drugs. GI-102 is an interleukin (IL)-2-based immunotherapy agent. In high doses, it increased the number of lymphocytes by sixfold after administration, significantly enhancing progression-free survival (PFS) compared to the competing drug Proleukin. These findings come from phase 1·2a clinical trials. GI-101A, used in combination therapy with Keytruda (pembrolizumab), has secured promising data, including partial remission (PR) in patients with pancreatic cancer, which is known to be particularly challenging to treat. 출처 : 더바이오(https://www.thebionews.net)

GI Innovation, a company specializing in innovative new drug development, announced on July 3 the registration of a material patent in China for their immunotherapy drugs ‘GI-101A and GI-102 (development code name)’.After successfully registering its patent in the United States, Europe, and Japan, Gi Innovation has now completed the registration of its material patent in China. This achievement grants the company exclusive rights to GI-101A and GI-102 in major countries within the global biopharmaceutical market. Patent rights play a critical role in the development and commercialization of novel drugs, influencing technology transfer and commercialization based on the regions where these patents are secured.출처 : 더바이오(https://www.thebionews.net)

GI Innovation, an innovative novel drug development company, revealed on May 27 its approval by the U.S. Food and Drug Administration (FDA) to develop a subcutaneous injection (SC) formulation of 'GI-102 (development code name)', a next-generation immunotherapy drug. This approval also involves a modification in the clinical trials (Investigational New Drug application) for phase 1/2 trials, combining both chemical and immune-cancer drugs. 더바이오(https://www.thebionews.net)

GI Innovation is accelerating the development of a subcutaneous (SC) formulation of its immuno-oncology candidate GI-102. 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. KBR(https://www.koreabiomed.com)

Developed by GI-Innovation, GI-301 is a dual-fusion protein new drug candidate designed using a platform that enhances drug safety by maintaining prolonged half-life function in the body while eliminating the antibody's inherent cell-killing function. In July 2020, the company signed a global technology transfer agreement, excluding Japan, with Yuhan Pharmaceuticals for preclinical stages, amounting to a total of $1.1 billion. In October 2023, GI-Innovation further signed a technology transfer agreement with the Japanese pharmaceutical company Maruho for development and commercialization within Japan, totaling $239 million, during the Phase 1 clinical trial stage. 히트뉴스(http://www.hitnews.co.kr)

GI Innovation, an innovative novel drug development company, revealed on February 27 that its allergy treatment 'GI-301' won the Technology Export Award at the 25th Korea New Drug Award (KNDA).Compared to Roche-Novartis' omalizumab, GI Innovation's allergy treatment 'GI-301' fills critical gaps in the allergy market. It provides robust and sustained suppression of IgE activity, effectively inhibits autoantibody activity responsible for allergies in patients with high blood IgE levels, and offers minimal side effects, particularly in children under the age of 6.출처 : 더바이오(https://www.thebionews.net)