NeoImmuneTech Receives FDA IND Approval for Phase 1 and 2 Trials Targeting Lymphocytopenia

[Asia Economy Reporter Chunhee Lee] NeoImmuneTech announced on the 1st that it has received approval from the U.S. Food and Drug Administration (FDA) for the clinical trial application (IND) for Phase 1/2 clinical trials of 'NT-I7' as a monotherapy in patients with Idiopathic CD4 Lymphocytopenia (ICL) in the 'NIT-114' study.

ICL is a rare disease characterized by a decrease in T cells, which play a crucial role in the body's immune system, without any specific cause. NT-I7 was previously granted Orphan Drug Designation (ODD) for ICL by the European Medicines Agency (EMA) in 2017 and by the FDA in 2019. Despite the COVID-19 pandemic, the clinical institution, the U.S. National Institutes of Health (NIH), has been proceeding with the approval process, and after completing all preparations, the Phase 1/2 clinical trials are set to begin this year.

This clinical trial is investigator-initiated, led by Professor Andrea Lisco of the NIH. It will evaluate safety and clinical efficacy, including T cell increase.

NeoImmuneTech stated, "T cell amplification has already been confirmed in several other clinical trials," expressing expectations for positive results. Through this, they plan to expand the value of NT-I7 in various cancers with poor prognosis due to lymphocytopenia, such as glioblastoma (brain cancer).