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)

GI Innovation's affiliate, GI Cell, announced on February 2 the submission of an application to the Ministry of Food and Drug Safety for phase 1 and 2a clinical trials to evaluate the safety and efficacy of GI's next-generation combination cancer therapy. The clinical trial is designed to assess the safety and potential efficacy of combining GI Cell's allogeneic NK cell therapy, 'T.O.P. NK,’ with GI Innovation's next-generation immunotherapy agent, 'GI-101A,' in patients with relapsed or refractory solid tumors. In the future, the two companies plan to expand their collaboration and are set to commence clinical trials for a combination therapy of T.O.P. NK and GI-102. The company describes T.O.P. NK as a next-generation NK cell therapy that can be mass-produced and is optimized to enhance its ability to target tumors and efficiently kill cancer cells. https://www.thebionews.net/news/articleView.html?idxno=3050

Samsung Biologics and Celltrion, the two leading pharmaceutical and biotech companies in Korea, will present their upcoming projects at the ‘JP Morgan Conference)' in San Francisco, USA, taking place from January 8 to 11, 2024 (local time). As a representative of Korea’s biotech sector, GI Innovation has received an official invitation from JP Morgan for three consecutive years, participating in one-on-one (1:1) meetings. In total, 9 Korean companies, including these three, have received official invitations from JP Morgan. The JP Morgan Conference, now in its 42nd year, is recognized as the largest global investment event for the pharmaceutical and biotechnology industries. Held annually at the Westin St. Francis Hotel in downtown San Francisco, investors, industry experts, government officials and world-renowned companies gather to share insights and discuss the latest market trends and medical innovations. As a major investment conference, the event has witnessed a number of significant mergers and acquisitions (M&A) and technology transfers both during and after the event. More than 8,000 people attended the 41st event held in January this year. https://www.thebionews.net/news/articleView.html?idxno=2146

GI Innovation said it licensed out GI-301, its allergy treatment candidate, to Maruho, a Japanese pharmaceutical company specializing in dermatology.Under the accord, GI Innovation is eligible for $221 million, including non-refundable upfront payments, development and commercial milestone payments, and royalties on further sales of GI-301 in Japan.Maruho will lead both the clinical development and commercialization efforts for GI-301 within the Japanese market.출처 : KBR(https://www.koreabiomed.com)

South Korea's bio-venture company GI Innovation has registered GI-301, an allergy treatment drug, and a microbiome-based combination therapy, at the European Patent Office. Through patent registration, the company can prevent other pharmaceutical firms from commercializing the microbiome by incorporating it into a fusion protein in Europe. GI-301 is a fusion protein capable of effectively handling allergic reactions with its Immunoglobulin E (IgE), a type of antibody that travels to cells. Because IgE overreacts to an allergen by producing antibodies, it can cause severe allergic diseases such as asthma and atopic dermatitis. According to GI Innovation CEO Rhee Byung-geon, GI-301 showed about 70 times higher lgE binding power than other competitive drugs and significant blood lgE reduction effect only with a single administration. https://www.ajudaily.com/view/20230727165321750

GI Innovation expressed its intention to pursue a license out deal for GI-301, an allergy treatment, with Japanese companies at a press conference at the Grand InterContinental Seoul Parnas Hotel, in southern Seoul, on Monday. "We are currently in talks with three Japanese pharmaceutical companies to transfer technology for GI-301, and we will finalize the transfer within this year," said GI Innovation CEO and Chairman Rhee Byung-gun.https://www.koreabiomed.com/news/articleView.html?idxno=21609

SEOUL -- South Korea's bio-venture company GI Innovation will adopt a new production process for the company's immune-oncology candidate substance called "GI-101." GI-101 is a dual fusion protein with the functions of CD80 and IL-2, proteins that play important roles in the immune system. Through a joint clinical trial with global pharmaceutical companies including America's MSD and Britain's AstraZeneca, the first patient treatment was launched in February 2023. According to the bio-venture on April 10, GI-101 produced through the new production process can increase the proliferation of anti-cancer immune cells in monkey models by about three times compared to the agent created through the existing process. https://www.ajudaily.com/view/20230410165240775