[Edaily Reporter KIM JI-WAN ] South Korea’s first advanced regenerative medicine treatment using “VT-EBV-N,” developed by ViGenCell Inc.(308080), will officially begin on the 1st.

This treatment is the “first advanced regenerative medicine treatment,” which was applied for by the Catholic University of Korea’s Yeouido St. Mary’s Hospital and approved by the Ministry of Health and Welfare last April; it is the first treatment plan approved since the advanced regenerative medicine treatment system was implemented in February of last year.

The treatment will be conducted at the Catholic University of Korea’s Yeouido St. Mary’s Hospital over the next two years and targets 15 patients with EBV-positive extranodal NK/T-cell lymphoma who have achieved complete remission but are at high risk of relapse. ViGenCell Inc. is responsible for the manufacturing and supply of “VT-EBV-N,” the product used in the treatment.

This treatment plan was advanced through a planned regulatory sandbox, which granted a regulatory exemption allowing the results of a commercial clinical trial—conducted with approval from the Ministry of Food and Drug Safety—to be used as the basis for the advanced regenerative medicine treatment plan. Previously, the standard procedure was to review treatment plans based on regenerative medicine technologies whose safety and efficacy had been confirmed through clinical studies of advanced regenerative medicine; however, under this regulatory exemption, the results of the commercial clinical trial for “VT-EBV-N” conducted by ViGenCell Inc. were used as the basis for assessing the safety and efficacy of the treatment plan.

Consequently, this is significant as it marks the first instance in which clinical evidence obtained from a drug clinical trial under the jurisdiction of the Ministry of Food and Drug Safety has been linked to an advanced regenerative medicine treatment under the jurisdiction of the Ministry of Health and Welfare. The government has also highlighted this case as the first approval of an advanced regenerative medicine treatment achieved through the use of the planned regulatory sandbox.

Prior to the treatment’s implementation, ViGenCell Inc. proactively secured the infrastructure necessary for the processing and supply of human cells and other materials required for advanced regenerative medicine treatments by obtaining a license for the cell processing facility at its “V-Cell Center”—the company’s advanced biopharmaceutical GMP center—in December 2024. Subsequently, while the treatment plan approval and administrative procedures by relevant government agencies were underway, the company completed manufacturing preparations at the V-Cell Center, establishing a system that allows it to begin production of “VT-EBV-N” as soon as the patient to be treated is confirmed.

“VT-EBV-N” is an antigen-specific T-cell derived from the patient’s own blood that recognizes a key antigen of EBV (Epstein-Barr virus).

In Phase 2 clinical trials, it achieved its primary endpoint by demonstrating a statistically significant improvement in 2-year disease-free survival (DFS) compared to the control group, and in the 4-year follow-up results presented in an oral presentation at the American Society of Clinical Oncology (ASCO 2026) on May 30, both the overall survival (OS) rate of 100% and the disease-free survival (DFS) rate of 95.0% were maintained.

With the start of treatment, ViGenCell Inc. is now able to accumulate additional real-world clinical data, supplementing the efficacy and safety data already obtained from previous clinical trials. Furthermore, by managing the entire process—from patient enrollment to cell manufacturing, quality control, and supply to medical institutions—in an actual treatment setting, the company plans to validate the supply capabilities necessary for future treatment expansion and commercialization.

Ki Pyeong-seok, CEO of ViGenCell Inc., stated, “Global interest in ‘preventing recurrence’—the ultimate goal of cancer treatment—is higher than ever, as evidenced by Moderna’s personalized mRNA cancer vaccine recently demonstrating efficacy in preventing recurrence and metastasis in a Phase 3 clinical trial for melanoma.” He added, “We expect this to serve as an opportunity for ‘VT-EBV-N,’ whose efficacy in suppressing recurrence has already been confirmed through long-term follow-up data, to once again draw attention.”

He went on to emphasize, “We will do our utmost to ensure stable manufacturing and supply by working closely with Yeouido St. Mary’s Hospital and government agencies so that patients can be freed from the fear of recurrence.”