VigenCell has announced plans to apply for conditional approval within the year as it successfully completed commercialization clinical trials for its NK/T cell therapy candidate ‘VT-EBV-N’.
According to the pharmaceutical and bio industry on the 27th, VigenCell received the final clinical study report (CSR) two and a half years after completing the administration of VT-EBV-N in Phase 2 clinical trials. This substance is a pure cell therapy product that isolates and cultivates cytotoxic T cells (CTL) in the body and is being developed for the treatment of highly malignant NK/T lymphoma among non-Hodgkin lymphomas.
On the 24th, VigenCell announced that the primary endpoint of the VT-EBV-N Phase 2 trial, the ‘2-year disease-free survival rate (DFS)’, was 95%, achieving statistical significance compared to the control group (77.58%) that received ‘autologous peripheral blood mononuclear cells (PBMC)’. Specifically, among the 21 patients administered VT-EBV-N, 1 experienced a relapse, and no deaths were reported. In contrast, in the control group, there were 6 relapses or disease progressions and 2 deaths among 25 patients.
The secondary endpoint set for VT-EBV-N, ‘overall survival (OS)’, yielded a value of 0.0580, which did not achieve statistical significance (the threshold is less than 0.05).
VigenCell interprets that maintaining a 100% survival rate in the experimental group helped to numerically enhance the survival trend compared to the control group.
Thus, the clinical procedures for VT-EBV-N, which have spanned approximately 30 years, have come to a close. VT-EBV-N has been a substance that began investigator-initiated Phase 1 trials targeting NK/T lymphoma patients since 1998. Based on this data, the commercial clinical trials for this substance were able to proceed directly to Phase 2 without Phase 1.
The administration procedures for the Phase 2 trial of VT-EBV-N were completed in September 2023. Typically, when clinical trials for a new drug are concluded, the results are announced within 6 months; however, in the case of VT-EBV-N, due to the nature of the disease, 2-year follow-up data was essential as the primary endpoint was set. This is why it took longer to release the results.
VigenCell plans to apply for expedited review with the Ministry of Food and Drug Safety in the first half of this year based on the results of the Phase 2 trial, and complete the conditional approval application in the second half. They aim to commercialize the substance with their partner, Boehringer, as early as 2027. If VT-EBV-N successfully commercializes, it will become the first cell therapy in the NK/T lymphoma field.
A representative from the cell therapy development industry stated, “If the primary endpoint is achieved, there are many cases where the failure to meet the secondary endpoint does not prevent approval, especially for diseases with high unmet needs.”
Meanwhile, VigenCell is also considering generating revenue through VT-EBV-N before market approval by utilizing the system under the ‘Act on the Safety and Support of Advanced Regenerative Medicine and Advanced Biopharmaceuticals (Advanced Regenerative Bio Act)’.
In the past, even if a drug was approved for therapeutic purposes and administered during the investigator-initiated clinical stage, the company had to bear all costs. The same was true for the investigator-initiated clinical trials of VT-EBV-N. Nevertheless, from the perspective of advanced biopharmaceutical developers, they had to spend costs to conduct investigator-initiated trials to secure data.
However, according to the revised Advanced Regenerative Bio Act amended in February last year, if approved for therapeutic purposes for patients with rare, intractable, or severe conditions, all related costs can be billed. However, it must pass the review of a committee formed by the Ministry of Health and Welfare and the Ministry of Food and Drug Safety.
A VigenCell representative stated, “Since this is the first application of the revised Advanced Regenerative Bio Act, it seems that the review is taking longer,” adding, “We hope to see the results in the first half of the year, but we cannot guarantee it.”
