Monday, February 10, 2025

NeoImmuneTech’s NT-I7 Receives FDA Orphan Drug Designation

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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.

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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.

Orphan Drug

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


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