VT-EBV-N / Boryung Group, ViGenCell - LARVOL DELTA

ViGenCell stumbles on survival data as Korea's NK-T cell therapy hopes dim (Chosun Biz) - "According to the final phase 2 results for the immune-oncology cell therapy 'VT-EBV-N,' disclosed on the 24th, the primary endpoint of 2-year disease-free survival (DFS) was 95% in the treatment arm, an improvement over the control group (77.58%). No deaths occurred in the treatment arm during the trial, while multiple deaths were reported in the control group. However, the secondary endpoint of OS did not achieve statistical significance. While the mortality rate in the control group was 16% and there were no deaths in the treatment arm, the trial failed to prove a statistically meaningful difference."

P2 data • Extranodal Natural Killer/T-cell Lymphoma

On December 2, VigenCell held a corporate briefing session at the Korea IR Council in Yeongdeungpo-gu, Seoul, and announced, "In February next year, we will proceed with the conditional approval process for our NK/T-cell lymphoma treatment candidate, 'VT-EBV-N,' and, in partnership with Boryung, begin domestic commercialization starting in 2027." (The Asia Business Daily) - "...VigenCell plans to apply for expedited review and conditional approval from the Ministry of Food and Drug Safety early next year."

Korea approval • Launch non-US • Extranodal Natural Killer/T-cell Lymphoma

ViGenCell posts statistically significant phase 2 results… (Chosun Biz) - "In the trial results, the primary efficacy endpoint, 2-year disease-free survival (DFS), was 95.0% in the treatment group and 77.58% in the control group. The difference between the two groups was analyzed as statistically significant (p=0.0347). In the treatment group, the incidence of relapse or death events was only 4.76% (1 patient). No serious adverse reactions were reported for safety."

P2 data • Extranodal Natural Killer/T-cell Lymphoma

Vigencell completes Phase 2 clinical trial for NK/T cell lymphoma treatment [Google translation] (HIT News) - P2 | N=48 | NCT03671850 | Sponsor: ViGenCell Inc. | "Vigencell...announced on the 26th that it has completed the administration of ‘VT-EBV-N (development code name)’ to 48 patients in phase 2 clinical trials for NK/T cell lymphoma...Vigencell plans to apply for expedited review designation and conditional product approval as soon as the phase 2 clinical trial is completed after two years of observation....'In a researcher-led clinical trial, VT-EBV-N achieved an overall survival rate of 100% and a 5-year disease-free survival rate of 90% for 11 patients with NK/T cell lymphoma.'"

P2 data • Trial status • Hematological Malignancies • Lymphoma • Oncology

Vigencell completes patient registration for phase 2 clinical trial of 'VT-EBV-N', immuno-oncology drug for lymphoma treatment [Google translation] (Health Korea News) - "Vigencell...is developing the flagship pipeline 'VT-EBV-N' for NK/T-cell lymphoma, a rare intractable hematological cancer. Phase 2 clinical trial patient enrollment was completed. If the clinical trial goes smoothly, it is expected to greatly contribute to Boryung's growth strategy specializing in anticancer drugs. According to the company on the 10th, 'VT-EBV-N', which has completed patient registration this time, is Epstein-Barr virus (EBV) positive based on ViTier™ platform technology, which is a development technology for antigen-specific killer T cell (CTL) treatment."

Enrollment closed • Hematological Malignancies • Lymphoma • Oncology