GI Inno "Allergy Treatment Technology Export to Japan Within the Year... 5 Global Technology Transfers in 5 Years"

Chairman Byung-gun Lee of GI Innovation is speaking at a press conference held on the morning of the 17th at the Grand InterContinental Parnas in Gangnam-gu, Seoul. Photo by GI Innovation

GI Innovation has announced its goal to license its allergy treatment to Japan within this year and to license an additional five pipelines globally within five years.

At a press conference held on the 17th at a hotel in Gangnam-gu, GI Innovation stated, "We are currently in discussions with three Japanese pharmaceutical companies for the licensing of the allergy treatment (GI-301). Once negotiations on the contract size are finalized, we will complete the technology transfer as soon as possible."

GI-301 is a compound that GI Innovation licensed to Yuhan Corporation in July 2020 for approximately 1.4 trillion KRW. This compound, being developed as an allergy treatment, is currently undergoing Phase 1b clinical trials in South Korea, and global rights excluding Japan were also transferred. Japan, where GI Innovation retains the rights, is a major market with a combined market size of about 4.4 trillion KRW for allergy diseases such as pollen allergy, asthma, chronic obstructive pulmonary disease (COPD), and atopic dermatitis. The current allergy treatment market is dominated by Novartis's Xolair and Sanofi's Dupixent (with sales of 11 trillion KRW). Lee Byung-geon, Chairman of GI Innovation, said, "Due to the characteristics of the Japanese market, there is significant interest in allergy treatments, and negotiations are progressing smoothly. We will strive to enter the Japanese market as quickly as possible."

GI Innovation explained that it is collaborating with Yuhan Corporation in clinical and business development fields aiming for global licensing of GI-301. The immuno-oncology agents ‘GI-101’ and ‘GI-102’ are also accelerating their global clinical trials. Executive Director Yoon Nari said, "GI-101 is currently in Phase 1/2 clinical trials, and as a monotherapy, it has achieved one complete remission (CR) and three partial remissions (PR) so far," adding, "Even as a monotherapy, it has shown efficacy in patients resistant to immuno-oncology agents, suggesting the possibility of overcoming resistance to immuno-oncology treatments." GI-101 is a bispecific fusion protein with functions of both ‘CD80’ and an ‘IL-2’ mutant, which activates immune cells and immune responses within cancer patients to treat cancer.

GI-101 recently introduced a new manufacturing process, received approval for clinical trial amendments, and is preparing for patient dosing. The new manufacturing process increases sialic acid content, which delays protein aging and enhances half-life and activity duration. Jang Myung-ho, Chief Strategy Officer (CSO), emphasized, "We expect strong anticancer activity results from the new GI-101 clinical trial with increased sialic acid content," and added, "We will do our best to quickly achieve technology transfer and conditional approval through additional clinical trials." Meanwhile, GI-102 has started domestic clinical trials and is preparing to enter clinical trials in the U.S. at two local hospitals. GI-102 is a candidate treatment for cancer patients with insufficient immune cells, where immuno-oncology agents show reduced efficacy.

The company also plans to submit an Investigational New Drug (IND) application for a new pipeline, the metabolic immuno-oncology agent ‘GI-108’, in the first half of next year. GI-108 is a bispecific fusion protein linking a ‘CD73’ neutralizing antibody, a fourth-generation anticancer agent, with an immune enhancer. It targets CD73-overexpressing cancers and inhibits the production of adenosine, a metabolic immune suppressor in the tumor microenvironment, thereby restoring the suppression of T cell and NK cell activation caused by adenosine. Specifically, the company explained that GI-108 showed about three times improved CD73 inhibition compared to AstraZeneca’s Oleclumab, which is in Phase 3 clinical trials. Compared to existing immune enhancers, GI-108 increased infiltration of CD8+ T cells and NK cells into tumors while reducing infiltration of regulatory T cells that interfere with anticancer effects.

Ko Young-jun, Head of Translational Strategy, said, "GI-108 has already completed clinical-grade drug substance production in collaboration with Samsung Biologics, and we expect to submit the IND application in the first half of next year," adding, "We plan to establish a product approval strategy with Medirama and conduct global clinical trials specialized for specific cancer types."

Chairman Lee Byung-geon also revealed the goal of five technology transfers within five years. He explained, "We have completed two technology transfers at the preclinical stage and aim for five additional technology transfers within five years," adding, "After promoting global licensing of GI-101 and GI-102, we will pursue licensing of GI-108."

He particularly emphasized, "Korean bio companies are overly focused on technology transfers, but technology transfer is only an intermediate step," and stressed, "The licensed products must obtain approval, be marketed, and generate royalties." He continued, "Domestic companies are only focused on the global market. Although domestic bio ventures have good technology, they lack experience," and said, "Even domestic companies should collaborate through ‘open innovation.’"

This content was produced with the assistance of AI translation services.