IN8bio receives orphan drug designation for INB-400/410

IN8bio announces FDA orphan drug designation for INB-400 and INB-410, covering a broad range of malignant glioma treatments, including newly diagnosed GBM. As an industry leader in gamma-delta T cell development, this milestone marks the first genetically modified gamma-delta T cell therapy to receive this designation, which offers potential incentives such as 7-year market exclusivity. In December 2022, the FDA cleared IN8bio’s investigational new drug application for a Phase 2 clinical trial in newly diagnosed GBM for INB-400. With Institutional Review Board review and site initiation ongoing, patient enrollment is expected to begin in the second half of 2023.