In8bio announces FDA clearance to initiate Phase 2 trial of INB-400

IN8bio announced that it has received clearance of its Investigational New Drug, IND, application from the U.S. Food and Drug Administration, FDA, to initiate a Phase 2 clinical trial of a genetically modified autologous gamma-delta T cell therapy, INB-400, targeting newly diagnosed glioblastoma, GBM. The study will assess the safety, efficacy and tolerability of genetically modified DeltEx drug-resistant immunotherapy, DRI, cells at leading medical centers across the United States. "Obtaining clearance to begin the INB-400 Phase 2 clinical trial is an important milestone for IN8bio as it is our first company-sponsored IND. This milestone demonstrates the clinical, regulatory and CMC capabilities of the IN8bio team in continuing to advance novel gamma-delta T cell therapies to cancer patients," said William Ho, Chief Executive Officer and co-founder of IN8bio. "The clinical program is designed to eventually assess DeltEx DRI with both autologous and allogeneic approaches in both the front-line and relapsed setting. We believe the insights we unlock in GBM will be essential as we apply our DeltEx platform across multiple solid tumor cancers."