Acute Radiation Syndrome Therapy Progresses

NeoImmuneTech, Inc. today announced that the European Medicines Agency (EMA) has granted Orphan Drug Designation (ODD) to NT-I7 for the treatment of Acute Radiation Syndrome (ARS).

This regulatory milestone follows the ODD granted to NT-I7 by the U.S. FDA for the same indication in November 2023.

ARS is a critical condition resulting from a high dose of radiation exposure, causing severe, sometimes fatal damage to the bone marrow and the immune system. No treatments are available that effectively promote T-cell recovery after such exposure.

NT-I7, a novel long-acting human interleukin-7 (IL-7), has shown promise to accelerate T cell reconstitution and enhance the immune response. It offers a potential solution for this unmet medical need. Clinical studies have shown that NT-I7 significantly boosts T cell counts while maintaining high safety and tolerability.

Luke Oh, Ph.D., President and Chief Executive Officer of NeoImmuneTech, said in a press release on June 4, 2024, "We are thrilled to see the deep interest of the scientific and regulatory community around the potential use of NT-I7 as a medical countermeasure in ARS."

"It is an important acknowledgment of the potential that NT-I7 holds in providing a beacon of hope for the treatment of ARS."

Examples of people who suffered from ARS are individuals exposed during the Hiroshima and Nagasaki atomic bombings and the Chernobyl Nuclear Power Plant incident firefighters.

NeoImmuneTech is actively developing NT-I7 in ARS through partnerships with the National Institute of Allergy and Infectious Diseases (NIAID) and Duke University. Recently, Duke University secured a $6 million grant from NIAID for NT-I7 development in ARS.