[Edaily Reporter KIM JI-WAN ] A “cancer vaccine” craze is sweeping the global anticancer drug market. This follows Moderna’s demonstration that its personalized mRNA cancer vaccine has the potential to suppress cancer recurrence.

Even before Moderna, there was a South Korean biotech company that had already achieved notable results with a cancer vaccine. That company is ViGenCell Inc.(308080). The company’s T-cell therapy, “VT-EBV-N,” recorded a 95% four-year disease-free survival (DFS) rate in Phase 2 clinical trials. This therapy is intended for patients with EBV-positive extranodal NK/T-cell lymphoma—a rare blood cancer—who have achieved complete remission (CR) after anticancer treatment but remain at high risk of recurrence. Typically, it is known that approximately 60–70% of patients with stage 3 or higher cancer experience a recurrence after achieving complete remission.

According to ViGenCell Inc. on the 14th, VT-EBV-N is set to begin treatment in its first patient. VT-EBV-N was approved last April by the Ministry of Health and Welfare as South Korea’s first advanced regenerative medicine therapy. Treatment began last month at Yeouido St. Mary’s Hospital, and the drug is currently being manufactured at a GMP facility.

Moderna’s Cancer Vaccine Sensation… The Essence Is ‘Preventing Recurrence’

Last August, Moderna and Merck (MSD) announced that an interim analysis of the Phase 3 clinical trial for the personalized mRNA cancer vaccine “Intismeran Autogen” (V940) met key endpoints related to the suppression of

recurrence

and distant metastasis. These results came from a comparison of “Keytruda” monotherapy versus combination therapy in high-risk melanoma patients who had undergone tumor resection.

This treatment is not a preventive vaccine designed to stop cancer from developing in healthy people. Moderna’s V940 analyzes a patient’s tumor genetic information to produce personalized mRNA. It then induces the patient’s immune system to recognize residual cancer cells. The focus is on preventing cancer recurrence, not on preventing cancer itself.

ViGenCell Inc.’s “VT-EBV-N” is also a treatment designed to prevent cancer recurrence. VT-EBV-N is an autologous T-cell therapy administered to patients with EBV-positive extranodal NK/T-cell lymphoma who have achieved complete remission following anticancer treatment. Its goal is to reduce the risk of recurrence by attacking invisible residual cancer cells.

While the two therapies differ in approach, they share the same goal of preventing cancer recurrence. Whereas Moderna trains the immune system using mRNA, ViGenCell Inc. directly cultivates the patient’s T cells to attack cancer cells. In other words, while the two therapies take different paths, they share the same destination: Seoul.

ViGenCell Inc. official emphasized, “Moderna’s results demonstrate that preventing recurrence can be evaluated as an independent treatment goal,” adding, “Whether the technology involves mRNA or immune cells, what matters is how long it can suppress recurrence in patients who have achieved complete remission.” The spokesperson continued, “If treatments that prevent cancer recurrence are called ‘cancer vaccines,’ then VT-EBV-N should also be called a ‘cell therapy’ in the narrow sense and a ‘cancer vaccine’ in the broader sense.”
95%

disease-free survival rate at 4 years… Relapse prevention efficacy comparable to Moderna’s cancer vaccine

VT-EBV-N’s core competitive advantage is complete prevention of relapse.

ViGenCell Inc. conducted a randomized, double-blind, placebo-controlled Phase 2 clinical trial involving 48 patients who achieved complete remission from EBV-positive extranodal NK/T-cell lymphoma at 13 medical institutions in South Korea, including Seoul St. Mary’s Hospital.

The primary efficacy endpoint, 2-year disease-free survival (DFS), was 95.0% in the treatment group and 77.58% in the placebo group. The difference of 17.42 percentage points was statistically significant (p=0.0347). DFS is the proportion of patients who survived without cancer recurrence or progression. Even during the 4-year long-term follow-up, DFS in the treatment group remained at 95.0%. In contrast, it decreased to 56.3% in the placebo group. Overall survival (OS) was 100% in the treatment group and 83.8% in the placebo group.

Moderna’s cancer vaccine was evaluated in a Phase 2b clinical trial involving 157 melanoma patients, with recurrence monitored over a 5-year period. The results showed that the 5-year recurrence-free survival rate for patients receiving the cancer vaccine in combination with Keytruda was 68.8%, which was 19.7 percentage points higher than the 49.1% rate observed in patients receiving Keytruda alone. Given that ViGenCell Inc.’s VT-EBV-N showed a 38.7 percentage point higher disease-free survival rate in the treatment group compared to the placebo group over a 4-year period, it is on par with Moderna’s cancer vaccine.

ViGenCell Inc. official emphasized, “VT-EBV-N maintained clear efficacy in preventing cancer recurrence during the 4-year follow-up,” adding, “This is highly significant because it confirms long-term suppression of recurrence, rather than merely temporary tumor shrinkage.”

Countdown to

First Dose… Simultaneous Push for Approval and Technology Transfer The first

patient

dosing

is now within sight.

According to the company, screening for the first patient has been completed, and VT-EBV-N is currently being manufactured at a GMP facility. Once the manufacturing and quality control procedures are finished, the drug will be administered to patients through medical institutions. The first administration is expected to take place as early as November, once drug production is complete.

The VT-EBV-N treatment involves culturing and proliferating EBV-specific T cells extracted from the patient’s own blood and then re-administering them intravenously. The treatment consists of weekly administrations for four weeks, followed by a four-week rest period, and then another four weeks of weekly administrations. It is administered over a total of eight sessions spanning approximately 12 weeks.

The cost of the VT-EBV-N advanced regenerative medicine treatment is 76.2 million won. However, patients initially pay only 40 million won at the start of treatment. If there is no recurrence within five years, they pay an additional 30 million won. Conversely, if a recurrence occurs within five years, the company will refund the full treatment cost to the patient. Note, however, that this treatment cost is limited to the amount specified under the Advanced Regenerative Medicine Act. The company has hinted that the price of the treatment will more than double after formal marketing authorization is granted.

ViGenCell Inc. is currently pursuing conditional marketing authorization for VT-EBV-N next year. To this end, the company applied for fast-track designation with the Ministry of Food and Drug Safety (MFDS) last July. It plans to submit an application for new drug approval as early as the fourth quarter of this year or, at the latest, in the first quarter of next year. Boryung will hold exclusive distribution rights for VT-EBV-N in South Korea.

According to the Health Insurance Review and Assessment Service (HIRA), the number of patients treated for T/NK-cell lymphoma (C86) in Korea in 2024 totaled approximately 1,900. The company projected that domestic sales of VT-EBV-N would start at 7.8 billion won next year and increase to 41.2 billion won by 2031. Cumulative sales over five years are estimated to reach 123.5 billion won.

The company is also actively pursuing technology transfer to China. The number of new patients with extranodal NK/T-cell lymphoma in China is estimated at approximately 11,600 this year and is projected to reach about 13,400 by 2029.

ViGenCell Inc. official stated, “We are actively pursuing technology transfers overseas, including in China, where the patient population is relatively large,” adding, “To this end, we have signed a contract with a Chinese consulting firm specializing in therapeutic technology transfers.” The official continued, “If VT-EBV-N receives conditional approval next year, both technology transfer and commercialization will be accelerated.”