GT Biopharma Adds University of Wisconsin--Madison Carbone Cancer Center as Second Site in Ongoing Phase 1/2 Clinical Trial of GTB-3550 TriKE™, a Novel NK Cell Therapeutic Cancer Treatment

BEVERLY HILLS, Calif., March 4, 2021 /PRNewswire/ -- GT Biopharma, Inc. (NASDAQ: GTBP), a clinical stage biopharmaceutical company focused on the development and commercialization of its disruptive, target-directed Natural Killer (NK) cell engager immunotherapy protein biologic platform technology: TriKE™ for cancer and infectious diseases, today announced the addition of a new clinical trial site for its ongoing GTB-3550 TriKE™ multicenter Phase I/II trial ( NCT03214666). The University of Wisconsin – Madison Carbone Cancer Center will serve as the second site for this program, with Kalyan Vara Ganesh Nadiminti M.D., UW Assistant Professor in Hematology, Oncology and Palliative Care, serving as lead investigator. Dr. Nadiminti will be working closely with Jeffery S. Miller, M.D., GT Biopharma's Consulting Chief Medical Officer and developer of TriKE™ and the trial design, and Erica Warlick, M.D., Principal Investigator, both of the University of Minnesota. UM's Masonic Cancer Center is the initial site of the GTB-3550 TriKE™ Phase 1/2 trial.

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.

About GTB-3550 TriKE™

GTB-3550 is the Company's first TriKE™ product candidate being initially developed for the treatment AML. GTB-3550 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.  We are evaluating GTB-3550 TriKE™ in a Phase I/II clinical trial for the treatment of acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), and other CD33+ hematopoietic malignancies.

About GT Biopharma, Inc.

GT Biopharma, Inc. is a clinical stage biopharmaceutical company focused on the development and commercialization of immunology therapeutic products based on our proprietary Trispecific Killer Engagers (TriKE™) target-directed Natural Killer (NK) cell engager platform. The TriKE™ NK protein biologic platform is designed to harness and amplify the body's native immune system for hope for patients with cancer and infectious diseases. GT Biopharma has an exclusive worldwide license agreement with the University of Minnesota, where Jeffery S. Miller, M.D., GT Biopharma's Consulting Chief Medical Officer, developed the TriKE™, to further develop and commercialize therapies using TriKE™ technology. For further information, please visit

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