GT Biopharma(US:GTBP) Globenewswire·2025-10-08 13:00Core Insights - The company is progressing well with Phase 1 enrollment, with both patients in Cohort 3 having initiated treatment without any dose-limiting toxicities or tolerability concerns to date [1][2] - The first patient in Cohort 3 has shown promising immune activation, consistent with previous cohorts, with further updates expected by year-end [1] - Upon successful completion of Cohort 3's safety assessment, the trial will escalate dosing into Cohort 4, planned for year-end 2025, with the potential to expand to 7 cohorts if necessary [1][2] Company Overview - GT Biopharma, Inc. is a clinical stage biopharmaceutical company focused on developing immuno-oncology therapeutics based on its proprietary TriKE NK cell engager platform [4] - The TriKE platform aims to enhance the cancer-killing abilities of natural killer cells in patients' immune systems [4] - The company holds an exclusive worldwide license agreement with the University of Minnesota for the development and commercialization of therapies utilizing TriKE technology [4] Trial Details - The Phase 1 trial protocol allows for the evaluation of GTB-3650 in approximately 14 patients across seven cohorts, with doses ranging from 1.25 µg/kg/day in Cohort 1 to 100 µg/kg/day in Cohort 7 [3] - Dosing will occur in two-week cycles, with treatment blocks lasting up to four months based on clinical benefit [3] - The trial will assess safety, pharmacokinetics, pharmacodynamics, in vivo expansion of endogenous NK cells, and clinical activity [3]