ViGenCell's VT-EBV-N to treat rare lymphoma patients over two years

South Korea has launched its first treatment under the country's advanced regenerative medicine framework, targeting patients with a rare form of lymphoma at high risk of relapse.

ViGenCell said Wednesday the treatment began using its VT-EBV-N therapy. The Catholic University of Korea's Yeouido St. Mary's Hospital applied for and received approval from the Ministry of Health and Welfare in April.

Over the next two years, 15 patients in complete remission from EBV-positive extranodal NK/T-cell lymphoma — a rare lymphoma with a high risk of relapse — will receive the treatment. ViGenCell is responsible for manufacturing and supplying VT-EBV-N for the program.

VT-EBV-N is an autologous blood-derived antigen-specific T-cell therapy that targets key antigens of the Epstein-Barr virus. In a Phase 2 trial, it met its primary endpoint by demonstrating a statistically significant improvement in two-year disease-free survival compared with a control group. Four-year follow-up data presented in an oral session at the American Society of Clinical Oncology annual meeting (ASCO 2026) on May 30 showed an overall survival rate of 100 percent and a disease-free survival rate of 95 percent.

The treatment plan advanced through a planned regulatory sandbox that granted a special exemption, allowing results from a commercial clinical trial approved by the Ministry of Food and Drug Safety to serve as the evidentiary basis for the advanced regenerative medicine treatment plan. Previously, treatment plans under the framework were reviewed based on regenerative medicine technologies whose safety and efficacy had been confirmed through advanced regenerative medicine clinical research. Under the new exemption, the commercial clinical trial results for VT-EBV-N were accepted as the basis for evaluating its safety and efficacy.

With treatment now under way, ViGenCell said it will be able to accumulate real-world clinical data on top of the efficacy and safety data already gathered from its earlier clinical trials.

"Interest in preventing cancer recurrence — the ultimate goal of cancer treatment — has grown, as seen recently with Moderna's personalized mRNA cancer vaccine," ViGenCell Chief Executive Ki Pyeong-seok said. "We expect VT-EBV-N, which has already demonstrated its relapse-suppression effect through long-term follow-up data, to draw renewed attention."


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