GT Biopharma Announces Commencement of Retreatment of Patient Demonstrating Successful Clinical Benefit following GTB-3550 TriKE(TM) therapy

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Patient Achieved Stable Disease

BEVERLY HILLS, CA / ACCESSWIRE / March 31, 2020 / GT Biopharma, Inc. (OTCQB:GTBP);(GTBP.PA) a company focused on developing innovative therapeutic treatments based on its proprietary NK cell engager TriKE™ platform announced today that it has been given approval and started retreatment on Monday March 30, 2020 of the first patient to receive the lowest dose of GTB-3550 in its GTB-3550 Phase I/II clinical trial for the treatment of acute myeloid leukemia (AML).

Following initial treatment, the patient achieved stable disease with respect to the number of AML blasts observed in their bone marrow before and after and showed no adverse events (side effects). Additionally, we observed an increase in the patient's total NK cell population attributable to the IL-15 component of the TriKE™ molecule with no appreciable increase of any hyper-active T-cell population which could have resulted in cytokine storm or other T-cell associated toxicities. The first advanced AML cancer patient enrolled in the clinical trial was treated at a dose of 5µg/kg/day GTB-3550 which is the lowest dose administered to patients enrolled in the GTB-3550 clinical trial.

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 ability to kill. GTB-3550, unlike therapy with CAR T-cells, does not involve expensive adoptive cell therapy protocols.

Acute myeloid leukemia is a heterogeneous hematologic stem cell malignancy in adults with an 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 without treatment. The five-year 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 commence retreatment of the initial patient, and look forward to continuing enrollment of new patients entering the clinical trial as our pause to free hospital beds for potential coronavirus patients abates." Mr. Cataldo further commented, "we remain optimistic that GTB-3550 will continue to demonstrate therapeutic benefit in AML cancer patients with advanced disease." Mr. Cataldo added, "We believe our AML TriKE™ will provide much better economics to the patients and our company then CAR T-cell therapies (Celegen and Gilead Sciences) that involve expensive adoptive cell therapy protocols.

The robustness of the TriKE™ platform allows us to develop therapeutics for the treatment of other cancers and certain infectious diseases including HIV and coronavirus infections. We most recently announced our Coronavirus TriKE™ partnership with USA-based manufacturing company Cytovance Biologics (a division of multi-billion dollar Shenzhen Hepalink Pharmaceutical Group of companies (002399:CH Shenzhen, CHINA). We are excited by the progress of our TriKE™ platform and will continue to update our shareholders as the Coronavirus TriKE™ and GTB-3550 TriKe™ continue to progress."

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 cancer cell and virus-infected cell killing using the patient's immune system 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 developed by researchers at the university to target NK cells.

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For more information, please visit www.gtbiopharma.com.

SOURCE: GT Biopharma, Inc.



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Released March 31, 2020