[Edaily Reporter Kim Ji-wan] #BigenCell announced on the 15th that it successfully completed an oral presentation on “VT-EBV-N,” a treatment for NK/T-cell lymphoma, at the European Hematology Association (EHA) Congress.

Biogencell presented the results of the Phase 2 clinical trial for ‘VT-EBV-N,’ a treatment for NK/T-cell lymphoma, via an oral presentation at the European Hematology Association (EHA) Congress held in Stockholm, Sweden, from June 8 to 11 (local time).

The presentation was delivered by Professor Yang Deok-hwan, a professor in the Department of Hematology at Chonnam National University Hwasun Hospital and Chair of the Lymphoma Research Committee of the Korean Society of Hematology.

This presentation is significant because it demonstrated overwhelming efficacy compared to the control group based on long-term follow-up data spanning four years, utilizing a rigorous clinical design that included randomization, double-blind testing, and a placebo-controlled approach in patients with Epstein-Barr virus (EBV)-positive extranodal NK/T-cell lymphoma (ENKTL).

The results of the four-year long-term follow-up showed that ‘VT-EBV-N’ achieved a four-year disease-free survival (DFS) rate of 95.0%. In the treatment group (21 patients), aside from one relapse confirmed at the two-year follow-up, no additional relapses or deaths occurred by the four-year mark.

In contrast, in the control group, the DFS rate, which was 77.6% at the 2-year follow-up, dropped sharply to 56.3% as recurrence and death events increased.

For the secondary endpoint, Overall Survival (OS), the VT-EBV-N group maintained a 100% OS rate at both the 2-year and 4-year marks, whereas the control group’s OS rate declined from 88% at 2 years to 83.8% at 4 years. The p-value was 0.0205, meeting the threshold for statistical significance.

No serious adverse drug reactions were observed, and serious adverse events commonly associated with CAR-T therapies, such as cytokine release syndrome (CRS) or neurotoxicity (ICANS), did not emerge as major issues.

A representative from VigenCell stated, “These study results represent a unique achievement in the treatment of intractable rare blood cancers characterized by chronic relapse and high mortality rates,” adding, “This confirms the drug’s potential as a dominant treatment in ‘consolidation therapy,’ which blocks minimal residual disease that remains in the body after complete remission and causes relapse.”

Ki Pyung-seok, CEO of VigenCell, said, “Based on the positive clinical results of ‘VT-EBV-N,’ we are seeing interest in our pipeline not only in the Chinese market—our primary target—but also in other countries such as Europe and Asia.” He added, “We will strive to gradually advance discussions at global academic conferences and partnering events to achieve the goal of technology export.”