INB-410 / IN8bio - LARVOL DELTA

IN8bio Receives FDA Orphan Drug Designation for INB-400/410 for the Treatment of Newly Diagnosed Glioblastoma (GlobeNewswire) - "IN8bio, Inc...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 (IND) for a Phase 2 clinical trial in newly diagnosed GBM for INB-400. With Institutional Review Board (IRB) review and site initiation ongoing, patient enrollment is expected to begin in the second half of 2023."

Enrollment status • Orphan drug • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor

IN8bio Reports Fourth Quarter and Full-Year 2022 Financial Results and Provides Corporate Update (GlobeNewswire) - "Upcoming Pipeline Milestones and Events:...(i) INB-400: Initiate patient enrollment in the company-sponsored Phase 2 trial of INB-400, a genetically modified autologous gamma-delta T cell therapy, targeting newly diagnosed GBM in the second half of 2023; (ii) INB-410: Submit a new IND to the FDA for a Phase 1b trial of INB-410, a genetically modified allogeneic gamma-delta T cell therapy in newly diagnosed and relapsed GBM in late 2023."

Enrollment status • IND • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Oncology • Solid Tumor