ViGenCell(308080)'s cell therapy "VT-EBV-N" will be used to treat patients starting on the 1st.
The treatment follows Korea's first advanced regenerative medicine treatment plan approved by the Ministry of Health and Welfare in Apr. It is the first treatment plan approved since the advanced regenerative medicine treatment system was implemented in Feb. 2025.
According to the company, The Catholic University of Korea Yeouido St. Mary's Hospital will begin VT-EBV-N treatment from the day for patients with Epstein-Barr virus (EBV)-positive extranodal NK/T-cell lymphoma at high risk of recurrence. The treatment period is two years, and the number of target patients is 15. ViGenCell will handle the manufacturing and supply of the cell therapy needed for treatment.
It is also the first case in which clinical evidence obtained from a drug clinical trial under the Ministery of Food and Drug Safety has led to treatment under advanced regenerative medicine overseen by the Ministry of Health and Welfare. The government is presenting this case as the first approval outcome for advanced regenerative medicine treatment using a planned regulatory sandbox. Until now, advanced regenerative medicine treatment has, in principle, reviewed treatment plans based on regenerative medicine technologies whose safety and efficacy were verified through advanced regenerative medicine clinical research.
ViGenCell established a manufacturing base before treatment. In Dec. 2024, it obtained approval for the cell processing facility of the V-Cell Center, an advanced biopharmaceutical GMP center. It completed manufacturing readiness to produce VT-EBV-N immediately once patients are confirmed.
VT-EBV-N is an antigen-specific T-cell therapy designed to recognize key antigens of EBV using cells obtained from the patient's own blood. In phase 2, it met the primary endpoint by improving the two-year disease-free survival (DFS) compared with the control group. In four-year follow-up results disclosed at the American Society of Clinical Oncology (ASCO 2026) in May, the overall survival (OS) remained at 100% and the disease-free survival at 95.0%.
The treatment is also expected to be another test for ViGenCell. In addition to data obtained in clinical trials, real-world treatment data will accumulate in actual clinical settings. By operating the entire real treatment process—from patient selection to cell manufacturing and quality control to supply to medical institutions—the company can also verify the production and supply capabilities needed for future treatment expansion and commercialization.
Chief Executive Ki Pyeong-seok of ViGenCell said, "Interest is growing in treatments to prevent cancer recurrence, such as personalized mRNA cancer vaccines," and added, "We expect this to be an opportunity to reaffirm the value of VT-EBV-N, which has demonstrated recurrence-suppression effects through long-term follow-up data."
He added, "We will work closely with Yeouido St. Mary's Hospital and government agencies to ensure stable manufacturing and supply so that patients can be freed from anxiety about recurrence."