Therapy Areas: Infectious Diseases
NeoImmuneTech's NT-I7 receives US FDA Orphan Drug Designation
21 November 2023 -

NeoImmuneTech, Inc. (NIT), a US-based, clinical-stage T cell-focused biopharmaceutical company, announced on Monday that it has received Orphan Drug Designation (ODD) from the US Food and Drug Administration (FDA) for its investigational drug NT-I7 (efineptakin alfa) (rhIL-7-hyFc) intended for the treatment of Acute Radiation Syndrome (ARS).

NT-I7 is a novel long-acting human interleukin-7 (IL-7) and is intended to address this unmet medical requirement, with the potential to rapidly recover and improve the immune response. In the clinical setting, the company said that the product has demonstrated impressive results by effectively and consistently increasing T cell counts, all while maintaining a remarkable level of safety and tolerance.

NIT said that the FDA's ODD for NT-I7 reflects progress in its efforts. A contract research organisation (CRO) under contract to National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), is conducting a study that employs well-developed NIAID ARS rodent models to investigate NT-I7's efficacy as a potential treatment for the serious health implications of ARS. NIAID is supporting this research through product development funding to the CRO.

Dr Se Hwan Yang, Ph.D., NIT president and chief executive officer, said, 'Obtaining the Orphan Drug Designation from the FDA is an important acknowledgment of the immense potential that NT-I7 holds in providing a beacon of hope for the treatment of ARS.'