YiPSCELL Receives Korean Patent Registration Decision for Low-Immunogenicity Universal iPSC Technology

Key Points

• YiPSCELL has received a domestic patent registration decision for low-immunogenicity universal induced pluripotent stem cell (iPSC) technology.
• The technology selectively lowers HLA-A, HLA-B, and HLA-DRA expression while keeping HLA-C, B2M, and CIITA expression from falling below parent-cell levels.
• YiPSCELL plans to apply the technology to a next-generation cartilage cell therapy and to link it with its clinical-grade iPSC cell line supply business.

YiPSCELL, an iPSC-based regenerative medicine company, announced on the 14th that it has received a domestic patent registration decision for low-immunogenicity universal iPSC technology. The patent covers methods for selectively regulating genes involved in immune recognition to reduce stem cell immunogenicity.

iPSCs can differentiate into many cell types and serve as a foundational cell source in regenerative medicine. However, when cells derived from another person are used therapeutically, immunological differences between patient and donor can trigger an immune response. Developing universal cells suitable for multiple patients requires technology that reduces this problem.

Rather than broadly suppressing immune-related genes, Ipsel’s approach distinguishes genes requiring regulation from those that should be maintained. Specifically, the technology is designed to lower expression of HLA-A, HLA-B, and HLA-DRA among human leukocyte antigen (HLA) genes, while keeping expression of HLA-C, B2M, and CIITA from falling below levels in the parent cells.

Findings from this research were published last March in Experimental & Molecular Medicine. The investigators confirmed that stem cell characteristics and differentiation capacity were maintained after gene editing, and in vitro immune cell evaluations produced results supporting reduced immunogenicity.

The work was supported by the Ministry of SMEs and Startups’ Scale-Up Tips program. Ipsel has been advancing low-immunogenicity foundational cell development and a next-generation chondrocyte cell therapy under research lead Nam Yu-jun, PhD, while preparing to connect the research results to an actual production process.

To that end, the company has secured GMP-grade plasmids for gene editing and established standard operating procedures for universal iPSC manufacturing, along with genetic stability assessment and quality testing systems. The aim is to move beyond functional cell research to a manufacturing base capable of repeatable production at consistent quality.

The technology also supports Ipsel’s ongoing cell line supply business. Last year, the company signed clinical-grade iPSC cell line distribution contracts with three institutions, Asan Medical Center, Etistem, and Celloid, totaling approximately 6 billion won including milestones. Separately, Ipsel reported cumulative revenue of 2 billion won from its cell line supply business over the past three years.

YiPSCELL is currently conducting clinical research on MIUChon, an osteoarthritis cell therapy candidate, and operating its clinical-grade iPSC supply business. The next-generation cartilage therapy using the patented technology is being pursued as a follow-on development program distinct from MIUChon, with plans to connect it to cell line supply, co-development, and technology transfer.

The reduced immunogenicity observed in this research reflects results from specific cell types and test conditions. Safety and efficacy as an actual therapeutic will require future verification in differentiated cells and by indication.

Nam Yu-jun, vice president of YiPSCELL, said: “We will expand the scope of the iPSC platform by connecting low-immunogenicity cell line technology to therapeutic development and cell line supply.”

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