Eutilex said it has submitted an orphan drug designation (ODD) application for EU204, a killer T-cell treatment targeting Epstein-Barr virus (EBV)-positive cancer patients, to the U.S. Food and Drug Administration.

EU204 is undergoing phase 1 and 2a clinical trials in Korea for patients with EBV-positive lymphoma and solid cancer.

Earlier this year, the company announced that it had confirmed complete remission (CR) in patients with natural killer (NK) and T-cell lymphoma with only one administration of EU204. Three NK and T-cell lymphoma patients received EU204 from the investigator-initiated trial (IIT). After drug administration, the company confirmed CR in all three patients showing an overall response rate (ORR) of 100 percent.

“If we receive FDA’s ODD approval, we can receive tax reductions and research subsidies during the clinical trial period, and rapid conditional commercialization will be possible after phase 2 clinical trials,” Eutilex CEO Choi Soo-young said. “Through ODD approval, we will improve clinical progress and cost-efficiency and promote rapid commercialization.”

EBV-positive NK and T-cell lymphoma is a rare and incurable disease, with a recurrence rate of nearly 80 percent and an average survival period of only six months at the time of recurrence.

The ODD is a system that supports the smooth development and approval of treatments for rare, intractable, or life-threatening diseases. Once designated as an orphan drug, the drug developers can benefit from reduced the period required for approval and clinical trials, tax credit, and exclusivity after obtaining authorization.