Neoimmuntech said Wednesday that the U.S. Food and Drug Administration has granted an orphan drug designation (ODD) for NT-I7, its immunotherapy candidate that treats glioblastoma multiforme (GBM), a type of brain cancer.

It was the fourth ODD designation for NT-I7. It also received ODD designations for progressive multifocal leukoencephalopathy from the FDA in 2020 and idiopathic CD4 lymphocytopenia from the FDA and European Medicines Agency in 2019 and 2017.

The company said it could receive ODD designation based on its multiple clinical data.

Notably, preliminary data from study NIT-107 presented at the Society for Immunotherapy of Cancer Annual Meeting (SITC) in November last year showed favorable trends of progression-free survival (PFS) and overall survival (OS) in NT-I7 treated high-grade gliomas (HGG) patients after chemo-radiotherapy.

"We are excited that the FDA granted NT-I7 an ODD in the treatment of GBM," NeoImmuneTech CEO Yang Se-hwan said. "The decision adds further credibility to our existing clinical evidence that NT-I7 has the potential to bring a new essential therapy option to people with advanced and metastatic GBM who have undergone prior chemoradiation therapy."

Yang added that the company looks forward to continuing its collaboration with FDA as it explores the benefits of NT-I7 in treating people with GBM in combination with other anti-cancer treatments, including immunotherapies.

The FDA's orphan drug designation supports the smooth development and approval of treatments for rare and intractable diseases. Once designated as an orphan drug, the drug developers can benefit from reduced the period required for approval and clinical trials, tax credit, and seven years of exclusivity after obtaining authorization.