Anthony J. Cataldo, GT Biopharma's Chairman and Chief Executive Officer, commented: "It is exciting to announce the addition of a second clinical trial site for our Phase I/II program of our novel GTB-3550 TriKE™ program. With this progress, we are closer to bringing our disruptive and target-directed NK cell engager approach to patients in need. We are grateful to the valiant patients and their families, as we continue to progress this initial indication trial of our first-in-class NK cell protein biologic cancer therapy."
GTB-3550 TriKE™ is being evaluated in patients age 18 and older with CD33+ malignancies (primary induction failure or relapsed acute myeloid leukemia [AML] with failure of one reinduction attempt, or high-risk myelodysplastic syndromes [MDS] progressed on two lines of therapy). The primary endpoint is to identify the maximum tolerated dose and safety of GTB-3550 TriKE™ therapy. Correlative objectives include the number, phenotype, activation status and function of NK cells and T cells. Interim results presented at the American Society of Hematology meeting on December 5, 2020 demonstrates GTB-3550 TriKE™ reduces bone marrow blast levels in AML and MDS patients with reported no toxicities, and improves NK cell function and proliferation.