ViGenCell, NK/T cell lymphoma treatment ‘VT-EBV-N’ designated as orphan drug in Europe

ViGenCell, a company specializing in immune cell therapy, announced on the 19th that its NK/T cell lymphoma treatment "VT-EBV-N" has been designated as an orphan drug in Europe. 

"VT-EBV-N", which was designated as an orphan drug by EMA , is based on the ViTier™ platform technology which is a technology for developing antigen-specific killer T cell (CTL) treatments. This is an immunotherapy drug with indications for Epstein-Barr Virus (EBV)-positive NK/T cell lymphoma. 

Following its designation as an orphan drug in the development stage by the Ministry of Food and Drug Safety (MFDS) of the Republic of Korea in 2019, it was also designated as an orphan drug by the European Medicines Agency (EMA) this month, raising the possibility that it could develop into a new treatment alternative for NK/T cell lymphoma in domestic and abroad. 

If designated as an orphan drug in Europe, there are benefits related to orphan drug approval, such as protocol support, various cost deductions, and market exclusivity in Europe for 10 years after launch. 

NK/T cell lymphoma, the indication for "VT-EBV-N", is a rare, incurable blood cancer with no standard treatment and a recurrence rate of 75% within 2 years. Currently, "VT-EBV-N" is undergoing follow-up observation after completing administration to 48 patients in phase 2 clinical trials in September. Investigator-Initiated Trial (IIT, phase 1) reported 100% of overall survival (OS) and 90% of 5-year progression-free survival (PFS) for 10 patients with NK/T cell lymphoma.

“We are pleased that the safety and efficacy of ViGenCell’s ‘VT-EBV-N’ will be recognized in domestic and abroad through this European orphan drug designation,” said Tai Gyu Kim, the CEO of ViGenCell.

“Based on this, in the mid to long term, we will expand the target countries for commercialization and expand the target market through additional clinical trials to expand indications for EBV-related diseases,” he added. “We will focus on R&D and strive to provide a new treatment alternative for NK/T cell lymphoma patients at home and abroad.” 

ViGenCell plans to apply for conditional product approval for "VT-EBV-N", which has been designated as an orphan drug in the development stage in Korea, as soon as phase 2 clinical trials are completed.

Write to Yoo-Rim Kim at youforest@hankyung.com