UPDATE: GT Biopharma Announces Preliminary Results for GTB-3550 TriKE(TM) Phase I/II Clinical Trial for Treatment of Acute Myeloid Leukemia

Patient Achieves Stable Disease

BEVERLY HILLS, CA / ACCESSWIRE / March 19, 2020 / GT Biopharma, Inc. (OTCQB:GTBP) (GTBP.PA) a biotherapeutics company focused on developing innovative therapeutic treatments in oncology and infectious diseases based on its proprietary NK cell engager TriKE™ platform announced today that it had successfully completed dosing of the first patient in a Phase I/II clinical trial of GTB-3550 for the treatment of relapsed/refractory acute myeloid leukemia (AML).

All patients enrolled in the open label clinical trial receive a single course of GTB-3550 given as four, 24-hour consecutive continuous infusions, for three consecutive weeks. The first patient with advanced relapsed/refractory AML who enrolled in the clinical trial was treated at a dose of 5µg/kg/day with GTB-3550. There were no observed adverse or serious adverse events recorded during the course of therapy, and the patient achieved stable disease as measured by AML blast count. We observed an increase in the patient's total NK cell population that we believe is attributable to the IL-15 component of the TriKE™ molecule. and with no appreciable increase of any hyper-active T-cell populations, which otherwise results in cytokine storm or other T-cell associated toxicities.

GTB-3550 is a tri-specific 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 NK cell stimulating cytokine human IL-15 portion of the molecule provides a self-sustaining signal that activates NK cells and enhances their cytotoxic activity.

Acute myeloid leukemia is a heterogeneous hematologic stem cell malignancy in adults with incidence rate of 3% to 5% per 100,000 people. The median age at the time of diagnosis is 65 to 69 years. AML is an aggressive cancer that is fatal on the absence of treatment. The five-year expected overall survival rate for AML is 27.4 percent, according to the National Cancer Institute (NCI).

Mr. Anthony Cataldo, the Chairman and Chief Executive Officer of GT Biopharma commented, "we are pleased to see these results in our first patient who is being administered GTB-3550." Mr. Cataldo further commented, "we remain optimistic that GTB-3550 will demonstrate therapeutic benefit in patients who have relapsed/refractory AML and other hematologic malignancies that are at an advanced stage." Mr. Cataldo added, "we believe the robustness of the TriKE™ platform will enable the development of therapeutics for the treatment of other cancers and certain infectious diseases, such as HIV and coronavirus infections."

About GT Biopharma, Inc.

GT Biopharma, Inc. is a clinical stage biopharmaceutical company focused on the development and commercialization of immuno-oncology and infectious disease therapeutic products based our proprietary Tri-specific Killer Engager (TriKE™) platform. Our TriKE platform is designed to harness and enhance the patient's immune system by stimulating and causing to persist natural killer cells (NK cells). GT Biopharma has an exclusive worldwide license agreement with the University of Minnesota to further develop and commercialize therapies using proprietary TriKE technology.

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SOURCE: GT Biopharma, Inc.

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