GT Biopharma Advances GTB-3650 Phase 1 Trial to Cohort 2 Following Successful Initial Human Dosing and Evidence of Early Immune Activation Signals

Core Insights - GT Biopharma, Inc. has successfully completed dosing in Cohort 1 and has initiated dosing in Cohort 2 of its Phase 1 trial for GTB-3650, targeting relapsed or refractory CD33 expressing hematologic malignancies [2][3] - No safety or tolerability issues were observed in Cohort 1, allowing the company to proceed with further dosing [1][3] - Early evidence of increased immunologic activity has been observed in patients from Cohort 1, indicating the potential effectiveness of GTB-3650 in activating natural killer (NK) cells [4] Company Overview - GT Biopharma is a clinical stage biopharmaceutical company focused on immuno-oncology therapeutics, utilizing its proprietary TriKE NK cell engager platform [6] - The company has an exclusive worldwide license agreement with the University of Minnesota for the development and commercialization of therapies using TriKE technology [6] Trial Details - The Phase 1 trial plans to evaluate GTB-3650 in approximately 14 patients across seven cohorts, with dosing occurring in two-week blocks [5] - The trial will assess various parameters including safety, pharmacokinetics, pharmacodynamics, and clinical activity [5]