NeoImmuneTech's NT-I7 wins EMA's orphan drug designation for acute radiation syndrome

NeoImmuneTech, a Korean clinical-stage T cell-focused biotech company,  said on Tuesday that NT-I7 (efineptakin alfa) has been granted organ drug designation (ODD) for acute radiation syndrome (ARS) by the European Medicines Agency (EMA). 

This  follows the previous ODD granted by  the U.S. FDA in November last year. NT-17's approval for ARS marks the seventh orphan drug designation, underscoring its efficacy in conditions requiring lymphocyte recovery, the company said.

ARS refers to a condition where rapid exposure to high doses of radiation within a short period of time results in organ damage and reduced levels of key cells such as neutrophils, platelets, and lymphocytes, increasing the risk of death from infections, among other complications. NT-I7 has consistently demonstrated good results in various clinical trials by increasing lymphocyte counts, NeoImmuneTech said.

NT-I7 is being developed as a treatment for ARS with active support from the U.S. government. The company is conducting preclinical studies with the National Institute of Allergy and Infectious Diseases (NIAID) to confirm the potential of NT-I7 as a treatment for ARS. Duke University has also received up to $6 million in funding from NIAID to conduct research on NT-I7's ability to improve survival rates and reduce the incidence of major infectious diseases.

"We are continuously expanding our clinical development efforts in Europe, including the recent establishment of our subsidiary In Poland and completion of registration as a small and medium-sized enterprise (SME) with the EMA,” NeoImmuneTech said. “The ODD for ARS from EMA, received much quicker than anticipated, also aligns with our mission. We will continue to leverage the various benefits offered by the EMA to further expand the development of NT-I7 within Europe."