NeoImmuneTech has achieved a significant milestone as the US Food and Drug Administration (FDA) granted orphan drug designation (ODD) for its investigational drug, NT-I7 (efineptakin alfa), to address Acute Radiation Syndrome (ARS), an acute and severe illness.
NT-I7, a clinical-stage long-acting human IL-7, is currently under development for oncologic and immunologic applications. This therapy is expected to bring clinical benefits by amplifying T cell numbers and enhancing their functionality.
NT-I7’s Difference as an Orphan Drug is Powerful Profile
What sets NT-I7 apart is its favorable pharmacokinetics/pharmacodynamics (PK/PD) profiles and a strong safety record. It is presently undergoing multiple clinical trials in the context of solid tumors and as a vaccine adjuvant, highlighting its versatility.
NeoImmuneTech’s plans include conducting studies to evaluate NT-I7’s effectiveness in treating additional solid tumors, hematologic malignancies, and other immunology-focused indications.
Dr. Se Hwan Yang, President and CEO of NeoImmuneTech, expressed enthusiasm about the FDA’s decision to grant orphan drug designation, recognizing the immense potential of NT-I7 in addressing ARS. Acute Radiation Syndrome arises when the entire body is exposed to high doses of penetrating radiation in a short time, resulting in severe damage to the bone marrow and the immune system. In clinical settings, NT-I7 has demonstrated promising outcomes by consistently boosting T-cell counts while maintaining a high level of tolerance and safety.
Resource: Pharmaceutical Business Review, November 21, 2023

This article has been prepared with the assistance of AI and reviewed by an editor. For more details, please refer to our Terms and Conditions. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author.