GT Biopharma has signed an expanded GMP manufacturing agreement with Cytovance Biologics for the manufacture of all TriKEs™. Previously, the lead candidate GTB-3550 TriKE™ was manufactured at the University of Minnesota's GMP manufacturing center, following its invention and development at the institution by GT Biopharma's Consulting Chief Medical Officer, Jeffrey S. Miller, M.D.
"This move positions the Company for large-scale commercial manufacturing in anticipation of an expanded GTB-3550 TriKE™ Phase 1/2 for Acute Myeloid Leukemia (AML) and Myelodysplastic syndromes (MDS). We are pleased with the work and dedication of our manufacturing partner, Cytovance Biologics, and look forward to progressing our solid tumor TriKEs™ (PD-L1, B7H3 and Herc 2), which represent the largest portion of the cancer market, last quarter to early first quarter next year. This expanded manufacturing capability positions us to initiate the process of additional clinical trials expected in early 2022," Anthony J. Cataldo, GT Biopharma's Chairman and Chief Executive Officer, said.
GTB-3550 TriKE™ is the Company's first TriKE™ product candidate being initially developed for the treatment of acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), and other CD33+ hematopoietic malignancies. GTB-3550 TriKE™ is a single-chain, tri-specific scFv recombinant fusion protein conjugate composed of the variable regions of the heavy and light chains of anti-CD16 and anti-CD33 antibodies and a modified form of IL-15. The natural killer (NK) cell stimulating cytokine human IL-15 portion of the molecule provides a self-sustaining signal that activates NK cells and enhances their ability to kill cancer cells and amplify the body's native immune system's NK cells.
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Patients with CD33+ malignancies (primary induction failure or relapsed AML with failure of one reinduction attempt or high-risk MDS progressed on two lines of therapy) age 18 and older are eligible (NCT03214666). The primary endpoint is to identify the maximum tolerated dose (MTD) of GTB-3550 TriKE™. 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 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.