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GT Biopharma Announces FDA Clearance of Investigational New Drug (IND) Application for GTB-3650, an NK Cell Engager for Treatment of CD33+ Leukemia
GT Biopharma (NASDAQ: GTBP), a clinical-stage immuno-oncology company, has announced FDA clearance for its Investigational New Drug (IND) application for GTB-3650, a novel NK cell engager targeting CD33+ leukemia. The Phase 1 trial for GTB-3650 is set to begin in the second half of 2024, with initial clinical data expected in the first half of 2025. Additionally, GT Biopharma plans to submit an IND for GTB-5550, targeting B7H3 positive solid tumors, in Q1 2025, with the corresponding Phase 1 trial expected to start later in 2025. The current cash runway is expected to fund operations into 2025. GTB-3650 will be assessed in a dose-escalation study involving adult patients with relapsed or refractory CD33 expressing hematologic malignancies, including AML and high-risk MDS. The study will evaluate safety, pharmacokinetics, pharmacodynamics, NK cell expansion, and clinical activity.
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