[Bio Story] 1. ViGenCell Sees Potential in Immune Cells' Evolutionary Power, Reports Success with the "First Advanced Regenerative Medicine Treatment"

Interview with ViGenCell CEO Ki Pyeongseok

Blood cancer therapy "'First under the Advanced Regenerative Medicine Act'" administered
Stem cell-derived NK cells take aim at brain tumors

Under the Advanced Regenerative Medicine treatment plan launched in September, ViGenCell's immune cell therapy VT-EBV-N will be administered to a patient for the first time. It is the first case of treatment under the Advanced Regenerative Medicine Act approved by the government for therapeutic use. A cell therapy previously used only in clinical trials has now entered actual clinical practice.

In an interview with The Asia Business Daily on October 20, ViGenCell CEO Ki Pyeongseok said, "The fact that cancer does not recur means that its defining characteristics have been neutralized. This treatment is the first step toward confirming that possibility in a patient."

First treatment under the Advanced Regenerative Medicine Act before product approval... Recurrence in just 1 of 21 patients over 4 years

VT-EBV-N is a treatment designed to prevent the recurrence of extranodal NK/T-cell lymphoma, a rare blood cancer. T cells taken from a patient's blood are trained to recognize cancer cells infected with the Epstein-Barr virus (EBV), then infused back into the patient's body. In April this year, the Ministry of Health and Welfare approved the treatment plan as the first treatment under the amended Advanced Regenerative Medicine Act. Yeouido St. Mary's Hospital will administer the treatment over two years to up to 15 patients at high risk of recurrence after chemotherapy.

The treatment is supported by the results of a Phase 2 clinical trial. After following 46 patients for four years, researchers found that cancer recurred in only 1 of the 21 patients who received VT-EBV-N, and none of those patients died. In the comparison group of 25 patients, only 56% remained recurrence-free over the four-year period. The results were presented in a formal oral presentation at the American Society of Clinical Oncology (ASCO) meeting in May this year, the first time a Korean cell therapy had been featured in that forum. "Although it was technically a Phase 2 trial, it was effectively a Phase 3 trial, because we set the dosage from the outset and compared the treatment with a control group," Ki said. "We were able to do that because we were confident it had a good chance of success."

ViGenCell CEO Ki Pyeongseok is being interviewed by The Asia Business Daily at the company's headquarters in Geumcheon-gu, Seoul. Photo by Kim Hyunmin.

"Immune cells have not yet evolved to fight cancer"... Changing the approach to evolve NK cells

The results stemmed from Ki's idea that immune cells' existing abilities, developed through their own evolution, could be harnessed as treatments. Ki believes that because human lifespans have increased so rapidly in a relatively short time, immune cells have not had time to evolve to fight cancer. By contrast, T cells have developed through a long evolutionary process the ability to eliminate virus-infected cells. Taking this insight, VT-EBV-N targets the EBV inside cancer cells rather than the cancer cells themselves. "If you give them the right message to kill virus-infected cells, they do it effectively," Ki explained. "That's why the treatment has been able to prevent recurrence."

For solid tumors unrelated to viruses, the company has chosen to evolve immune cells in the laboratory. Its follow-on pipeline candidate, VC-302, is a CAR-NK therapy made by introducing cancer-recognition genes into induced pluripotent stem cells (iPSCs) and then differentiating them into natural killer (NK) cells. "NK cells have a tendency to stop working when their genes are altered. Our know-how lies in finding the NK cells among them that are good at killing cancer cells," Ki explained. In mouse experiments on brain tumors conducted with Professor Pi Jihoon of Seoul National University Hospital, the tumors disappeared in all three trials.

Production costs are also considered a strength of the therapy. Chimeric antigen receptor (CAR) T cells require each patient's own cells to be processed individually, driving production costs to several hundred million won and the price of a single treatment to more than 500 million won. By contrast, ViGenCell says it can produce a vial of its iPSC-based NK cell therapy for several hundred thousand won. The company says that even with 10 doses, the cost could be reduced to one-hundredth the cost of a single CAR-T treatment. ViGenCell's ultimate goal is to mass-produce cell therapies like antibody drugs and supply them to the market.

Preparing for product approval... "We will do what the United States couldn't"

ViGenCell is preparing data to show that it can consistently manufacture products of the same quality as it seeks product approval for VT-EBV-N. The company aims to advance VC-302 to a stage where it can enter clinical trials in the first half of 2027. "Cell therapy is a field that even the United States finds challenging, so the companies that work hard are the ones that win," Ki said. "Rather than being a fast follower, I want to lead the way and create cell therapies with a global impact."

Ki Pyeongseok, CEO of ViGenCell, poses during an interview with The Asia Business Daily at the company's headquarters in Geumcheon-gu, Seoul. Sept. 15, 2026. Photo by Kim Hyunmin

This content was produced with the assistance of AI translation services.