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

GI Innovation outlined ambitious plans to transfer at least five additional technologies within the next five years at its initial public offering (IPO) briefing session at the Conrad Hotel in Yeouido, Seoul, Monday.Established as a bio-venture in 2017, GI Innovation researches and develops next-generation immunotherapy drugs based on dual fusion proteins. The company's major pipelines include dual fusion immuno-cancer drugs GI-101 and GI-102, and allergy treatment GI-301 which are in clinical trials alongside other preclinical drug candidates GI-104, GI-108, and GI-305.https://www.koreabiomed.com/news/articleView.html?idxno=20640

GI Innovation said Thursday that it has won approval in the preliminary screening to be listed on the Kosdaq market from the Korea Exchange (KRX). The approval came eight months after the company applied for a preliminary review in April. Read More

Preliminary results of GII-101-P101 (Keynote-B59): GI-101 (CD80-IgG4 Fc-IL2v) as a single agent and in combination with pembrolizumab in patients with advanced and/or metastatic solid tumors

Local drug developer GI Innovation said Thursday its Merkel cell cancer drug GI-101, used to treat a rare type of skin cancer, has received orphan drug designation from the United States Food and Drug Administration.The designation is given to drugs that treat rare diseases that affect less than 100,000 people. The status gives tax cuts during clinical trials, and waives certain restrictions and fees. It also allows market monopolization for seven years after the drug is launched.Merkel cell cancer appears between the dermis and epidermis of the skin and mostly affects those over 50. The five-year survival rate is less than 20 percent.GI Innovation said it hopes the designation will accelerate clinical trials for its Merkel cell cancer drug. Read More

SEOUL -- A material patent for GI-301, an allergy treatment drug candidate developed by South Korea's bio-venture company GI Innovation, has been registered in Japan where pollen allergy diseases are widespread. The company would try to accelerate technology transfer to Japanese pharmaceutical companies.GI-301 is a biologic for the treatment of allergic diseases, including atopic dermatitis and chronic idiopathic. Yuhan, a pharmaceutical and chemical company in South Korea, signed a contract worth some 20 billion won ($15 million) in 2020 to co-develop and sell GI-301 in overseas markets except for Japan. Read More

GI-101, an immunotherapy agent being developed by South Korea's bio-venture company GI Innovation, has been selected for a government-initiated drug development program to receive financial support at clinical stages. GI Innovation said it would get up to seven billion won ($5.5 million) in research support for two years from the Korea Drug Development Fund (KDDF), which supports the investment, nurture and development of promising drugs. KDDF's move is seen as a symbolic recognition of GI Innovation's technological prowess. Read More