On July 22, 2020 GT Biopharma, Inc. (OTCQB:GTBP)(GTBP.PA) (the "Company or GT Biopharma") an immuno-oncology company focused on innovative therapies based on the Company’s proprietary natural killer (NK) cell engager (TriKE) technology reported that it had completed a private offering resulting in aggregate gross proceeds of approximately $5.6 million (Press release, GT Biopharma, JUL 22, 2020, View Source [SID1234562236]).

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GT Biopharma is conducting its FDA Phase I/II Clinical Trial for GTB-3550 at the Masonic Cancer Center, University of Minnesota under the direction of Dr. Erica Warlick. 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 (AML) 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%, according to the National Cancer Institute (NCI). The monies raised by the financing will be used to fund the further clinical development of the Company’s TriKE product candidates, including GTB-3350.

Mr. Anthony Cataldo, the Chairman and Chief Executive Officer of GT Biopharma, commented "we are pleased to have completed our bridge financing which allows us to continue to fund our FDA clinical trial and helps to position the Company to seek approval for listing on a national securities exchange ." Mr. Cataldo also stated "we are pleased with the progress our clinical development team is making with the evaluation of GTB-3550 in AML advanced cancer patients and will be providing further clinical updates to our stakeholders in the coming weeks."

About GTB-3550 Trispecific NK cell Engager (TriKE)

GTB-3550 is the Company’s first TriKE product candidate being initially developed for the treatment of 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 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 intend to study GTB-3550 in CD33 positive leukemias such as AML, myelodysplastic syndrome and other CD33+ hematopoietic malignancies.