GT Biopharma Announces Publication of Trike(TM) Results Targeting Multiple B7H3 Positive Cancers

GT Biopharma announces the publication of "NK-Cell-Mediated Targeting of Various Solid Tumors Using a B7-H3 Tri-Specific Killer Engager In Vitro and In Vivo" in the journal Cancers, volume 12, issue 9, page 2659; (https://doi.org/10.3390/cancers12092659). The research effort was conducted by researchers at the University of Minnesota and at Massachusetts General Hospital/Harvard Medical School.

B7H3 (CD276) is a costimulatory membrane protein, and a member of the B7 family of costimulatory membrane proteins which include PD-1, PD-L1 and CTLA-4. B7 family members such as PD-1/PD-L1 and CTLA-4 play important roles in the checkpoint blockade of immune cells by cancer cells. B7H3 is highly expressed on the surface of several types of cancer, and exhibits low expression on normal tissues. The findings presented indicate that a B7H3-targeted TriKE™ has the potential to enhance natural killer (NK) cell immunotherapy in solid tumor settings, and supports its further clinical development.

Mr. Anthony Cataldo, the Chairman and Chief Executive Officer of GT Biopharma, commented "we are pleased with the results of the research, and expect to advance a B7H3 TriKE™ product candidate to clinical development."

About GTB-3550 TriKE™ FDA Clinical Trial

GTB-3550 is the Company's first TriKE™ product candidate being initially developed for the treatment of acute myeloid leukemia (AML). 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. We are presently evaluating GTB-3550 in a Phase I/II clinical trial (ClinicalTrials.gov NCT03214666) for the treatment of CD33 positive leukemias such as AML, myelodysplastic syndrome and other CD33+ hematopoietic malignancies.

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