Securing Non-Clinical Data by 2026
Aiming for Phase 1 IND Approval
GC Cell announced on May 8 that its project to develop a systemic lupus erythematosus treatment using its new drug candidate 'CD19 CAR-NK' has been selected for the 2025 Pan-Ministerial Regenerative Medicine Technology Development Project led by the Pan-Ministerial Regenerative Medicine Technology Development Project Group.
The Pan-Ministerial Regenerative Medicine Technology Development Project is a national research and development initiative jointly promoted by the Ministry of Science and ICT and the Ministry of Health and Welfare. The project will invest a total of 595.5 billion KRW by 2030 to support the entire cycle from the discovery of core and fundamental technologies in the field of regenerative medicine to the clinical stage of therapeutics and treatment technologies.
This project (25C0201L1) targets the indication of systemic lupus erythematosus (SLE), aiming to secure non-clinical data and obtain domestic Phase 1 clinical trial IND approval by 2026. With this selection, GC Cell will receive a total of 1.25 billion KRW in research funding.
Systemic lupus erythematosus is an autoimmune disease in which increased autoantibodies, due to B cell activation, cause immune system abnormalities that attack healthy tissues in the body, leading to inflammation and tissue damage. There are more than 5 million patients worldwide, and over 40% of diagnosed adults progress to lupus nephritis (LN), a life-threatening complication, making it a refractory disease.
GC Cell's 'CD19 CAR-NK' is a CAR-NK cell therapy that maximizes CAR-NK cell activity with a patented CAR (chimeric antigen receptor) signaling domain and co-expresses interleukin 15 (IL-15) to enhance in vivo persistence and efficacy. By targeting CD19 on the surface of B cells, it effectively eliminates the B cells that cause the disease.
GC Cell has confirmed excellent efficacy, in vivo persistence, and safety through various non-clinical studies on 'CD19 CAR-NK.' The company has also secured technology for large-scale cultivation and long-term storage of 'off-the-shelf' cell therapies with guaranteed quality, achieving both price competitiveness and supply stability.
This pipeline was also selected last year as a non-clinical stage support project under the National New Drug Development Project, aiming to develop therapeutics for B-cell lymphoma.
Won Sungyong, CEO of GC Cell, stated, "With this selection, we will accelerate the development of CD19 CAR-NK and do our utmost to develop new treatments for patients with refractory autoimmune diseases." He added, "We plan to further solidify our leading position in both domestic and international markets by expanding our R&D competitiveness beyond hematologic cancers to the field of autoimmune diseases."
Meanwhile, in March, GC Cell announced a co-CEO system with Won Sungyong (R&D) and Kim Jaewang (Sales) through a board resolution, and has since focused on strengthening R&D capabilities under the leadership of CEO Won Sungyong.
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