News Update

NeoImmuneTech’s Polish Subsidiary Obtains SME status


 - European small and medium-sized enterprise (SME) designation opens doors to funding and regulatory support for NT-I7 development

 - SME status accelerates global development of NT-I7 for rare immune disorder


30 May 2023 — ROCKVILLE, MD: NeoImmuneTech, Inc. (NIT or “NeoImmuneTech”), a clinical-stage T cell-focused biopharmaceutical company, today announced that its Polish subsidiary has been granted SME status by the European Medicines Agency (EMA). This recognition is an important milestone for NeoImmuneTech, providing financial and regulatory support that will accelerate the development of its lead drug candidate NT-I7 for the treatment of Idiopathic CD4+ Lymphocytopenia (ICL).


The SME status is crucial for gaining access to finance and benefiting from EU support programs specifically tailored for small and medium-sized enterprises. It provides continuous support from the EMA, including fee reductions, administrative assistance, and scientific guidance. Additionally, this status qualifies NeoImmuneTech for the EMA's Priority Medicines (PRIME) scheme, opening the door for expedited development of innovative treatments.


ICL is a rare disorder characterized by abnormally low levels of CD4+ T cells, a type of white blood cell essential for the immune function. Unlike HIV/AIDS, which also affects CD4+ T cells, ICL occurs without any evidence of underlying infection or other known causes of immune deficiency. Currently, the treatment for ICL focuses primarily on managing symptoms and preventing complications. While there is no specific cure yet, NT-I7 is emerging as the most promising potential treatment.


NeoImmuneTech has made significant progress in developing NT-I7, which has already been granted Orphan Drug Designation (ODD) by the EMA for ICL in 2017. The new SME status will further bolster the company’s efforts to bring NT-I7 to market more swiftly, enhancing its capabilities to address unmet medical needs in the field of immunotherapy.



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