VigenCell: "New Cell Lymphoma Drug to Be Commercialized in 2027... 120 Billion Won in Sales Expected Over 5 Years"

VT-EBV-N to Apply for Conditional Approval in February Next Year
Phase 2 Clinical Trial Shows 95% Two-Year Disease-Free Survival Rate
Aiming for Domestic Launch with Boryung in 2027

VigenCell, a company specializing in immune cell therapy, is moving toward early commercialization after presenting significant results in Phase 2 clinical trials of its treatment for the rare blood cancer, cell lymphoma.

Kipyeong Seok, CEO of VigenCell, held a corporate briefing session on the 2nd at the Korea IR Council in Yeongdeungpo-gu, Seoul, explaining the cell lymphoma treatment under development. Photo by VigenCell

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."

According to the topline data from Phase 2 clinical trials for VT-EBV-N, VigenCell's main pipeline, the two-year disease-free survival (DFS) rate was 95%, with zero deaths reported. This is a statistically significant figure (p-value 0.0347) compared to the control group (77%). Notably, all patients in the treatment group survived for two years, and the event rate, such as recurrence, was only 4.76% (1 patient). In contrast, the event rate in the control group reached 32% (8 patients). For the secondary endpoint of overall survival (OS), there were also no deaths in the treatment group, and the two-year DFS after the last patient enrollment showed superior trends in the treatment group. No serious adverse reactions or side effects were observed.

This Phase 2 clinical trial was conducted using a randomized, double-blind method at 13 medical institutions nationwide, including Seoul St. Mary's Hospital. It targeted 48 patients with NK/T-cell lymphoma, with dosing completed in September 2023, followed by a two-year observation period.

Based on these results, VigenCell plans to apply for expedited review and conditional approval from the Ministry of Food and Drug Safety early next year. Previously, VT-EBV-N was designated as an orphan drug in development by the ministry in 2019.

The company aims to begin domestic commercialization in the first half of 2027 in collaboration with its partner, Boryung. Ki Younguk, Executive Director of VigenCell, stated, "VT-EBV-N is the world's only immune cell therapy for NK/T-cell lymphoma, with no competing drugs. As a first-line treatment, we expect to achieve a market penetration rate of 80-90%, generating sales of 120 billion won in Korea alone over the next five years."

VigenCell is also renewing its efforts for global technology licensing, targeting the Chinese market, where the number of patients is more than 30 times higher than in Korea. The number of NK/T-cell lymphoma patients in China is estimated at 11,660, with the market size reported to be approximately 1.06 trillion won.

Kipyeong Seok, CEO of VigenCell, said, "These topline results are a very meaningful achievement after seven years of extensive research. They demonstrate the potential future role of cell therapies." He further emphasized, "While the bio market in the past was centered on antibody therapies, cell and gene therapies will now take the lead. We aim to develop cell therapies that not only target blood cancers but also address solid tumors in the future."