Baijensel: Phase 2 Trial of NK/T-Cell Lymphoma Therapy Shows Significant Efficacy with No Deaths

2-year disease-free survival 95% vs. 77.6% in the control group

Baijensel announced on the 24th that it has received the final clinical study report (CSR) for its phase 2 trial of VT-EBV-N, a treatment for NK/T-cell lymphoma. Based on these results, the company plans to pursue an application for conditional product approval in the second half of the year.

Baijensel company logo image. Baijensel

In this phase 2 trial, the primary endpoint, 2-year disease-free survival (DFS), was 95.0% in the treatment group and 77.58% in the control group. The company explained that statistical significance was also achieved. During the trial period, no deaths were reported in the treatment group, and no serious adverse events were identified, according to the company.

This trial applied a randomized, double-blind design, which is rare for a cell therapy clinical study. The company stressed that this design enhanced the objectivity and reliability of the data.

Baijensel plans to seek designation for expedited processing as an advanced biopharmaceutical and to submit an application for Global Innovative product Fast Track (GIFT) review in the first half of the year, followed by an application for conditional product approval in the second half. The company also intends to simultaneously pursue overseas business expansion, focusing on China, along with technology transfer.

Baijensel CEO Pyeongseok Ki said, "We plan to proceed with the approval application and commercialization process based on the clinical results," adding, "We will work to provide a new option for patients with NK/T-cell lymphoma, for whom treatment options are limited."