IN8bio's INB-400, INB-410 GMB Treatments Designated Orphan Drug by FDA
IN8bio Inc. on Tuesday said INB-400 and INB-410 received the U.S. Food and Drug Administration's orphan drug designation for a range of malignant glioma treatments, including newly diagnosed glioblastoma multiforme.
Glioblastoma multiforme is an aggressive and difficult to treat brain cancer. The FDA in December cleared the New York-based clinical-stage biopharmaceutical company's investigational new drug application for a Phase 2 clinical trial of INB-400 for treatment of glioblastoma multiforme.
IN8bio said patient enrollment in the Phase 2 trial of INB-400 is expected to begin in the second half of 2023, with an Institutional Review Board review and site initiation ongoing.
Apr 25, 2023