ViGenCell’s cell therapy product VT-EBV-N is being used to begin South Korea’s first advanced regenerative medicine treatment for patients at Catholic University Yeouido St. Mary’s Hospital.
The treatment, approved by the Ministry of Health and Welfare in April, will run for two years and involve 15 patients with Epstein-Barr virus (EBV)-positive extranodal NK/T-cell lymphoma who are in complete remission but at high risk of relapse.
ViGenCell will manufacture and supply VT-EBV-N, a personalized cell therapy made from patients’ own T cells and engineered to target specific EBV antigens.
The treatment is the first approved under South Korea’s advanced regenerative medicine treatment system, which was introduced in February 2024. It also represents the first case in which results from a commercial clinical trial approved by the Ministry of Food and Drug Safety are being used as evidence for an advanced regenerative medicine treatment plan under the Ministry of Health and Welfare.
ViGenCell has prepared its V-Cell Center, which received approval as a cell-processing facility for advanced biopharmaceuticals in December 2024, allowing the company to begin manufacturing VT-EBV-N once patients are confirmed.
The therapy previously achieved its primary endpoint in a Phase 2 clinical trial by significantly improving two-year disease-free survival compared with the control group. Four-year follow-up data presented at ASCO 2026 showed an overall survival rate of 100% and a disease-free survival rate of 95.0%.
ViGenCell plans to use real-world treatment data from the program alongside existing clinical trial results while testing its ability to manage the entire process from patient confirmation and cell manufacturing to quality control and hospital delivery.