GT Biopharma Announces Dosing Of New Patient In GTB-3550 TriKE(TM) Phase I/II Clinical Trial

FIRST PATIENT ACHIEVED STABLE DISEASE WITH NO ADVERSE SIDE EFFECTS

LOS ANGELES, CA / ACCESSWIRE / May 27, 2020 / GT Biopharma, Inc. (OTCQB:GTBP) (GTBP.PA) an immuno-oncology company focused on NK cell engager (TriKE™) technology. GT announced today that the second patient of the lowest dose of an ascending dose finding study has begun treatment of the GTB-3550 TriKE™. The patient will be evaluated following completion of the third cycle of GTB-3550 TriKE™ therapy. The clinical trial is being conducted at the University of Minnesota's Masonic Cancer Center in Minneapolis. Additional clinical trial sites are now being processed.

The first patient of the Phase I/II study achieved stable disease and increased NK cell production with no adverse side effects. The first patient elicited an encouraging initial efficacy marker response.

The TRIKE™ clinical trial evaluates GTB-3550 in patients with acute myeloid leukemia or advanced systemic mastocytosis, and will determine safety and tolerability as well as the pharmacologically active dose and maximum tolerated dose of GTB-3550.

TriKE™ is a multi-targeted immuno-oncology protein-based therapeutic drug. The TriKE™ addresses the patient delivery and administration issues of liquid tumor cell therapies and NK engagers. Pre-clinical data shows that The TriKE™ platform technology works in both liquid and solid tumors.

About GTB-3550 Trispecific NK cell Engager (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. The Company is currently in a clinical trial with GTB-3550 in CD33 positive leukemia for acute myeloid leukemia (AML), and is studying myelodysplastic syndrome (MDS), and other CD33+ hematopoietic malignancies along with other solid tumor candidates.

About GT Biopharma, Inc.

GT Biopharma, Inc. is a clinical stage biopharmaceutical company focused on the development and commercialization of immuno-oncology therapeutic products based our proprietary Tri-specific Killer Engager (TriKE™) platform. The TriKE™ platform is designed to harness and enhance the cancer killing abilities of a 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 cancer therapies using proprietary TriKE technology developed by researchers at the university to target NK cells to cancer.

Forward-Looking Statements

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

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SOURCE: GT Biopharma, Inc.

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