eClinical Technology and Industy News

GT Biopharma Advances GTB-3650, a Second-Generation Tri-Specific Killer Engager -TriKE®, Into IND-Enabling Studies

– GTB-3650 is a novel molecule based on camelid single-domain antibody technology with advantages that build upon the strong proof-of-concept data from the Company’s first-generation TriKE® program, GTB-3550

– GTB-3650 has shown significantly higher potency than GTB-3550 in preclinical models, as detailed in a recent peer reviewed publication¹

– Company now plans to accelerate its transition from the ongoing GTB-3550 Phase 1 program into its next generation TriKE®, GTB-3650, for patients with relapsed/refractory acute myelogenous leukemia (AML) and high-risk myelodysplastic syndrome (MDS)

Excerpt from the Press Release:

BEVERLY HILLS, Calif., Sept. 13, 2021 /PRNewswire/ — GT Biopharma, Inc. (the “Company”) (NASDAQ: GTBP), a clinical stage immuno-oncology company focused on developing innovative therapeutics based on the Company’s proprietary natural killer (NK) cell engager, TriKE® protein biologic technology platform, today, announces the advancement of GTB-3650 into IND-enabling studies, with which it plans to supplant the ongoing Phase 1 program with GTB-3550.

Therapeutic and commercial advantages of GTB-3650 compared to GTB-3550 include:

  • Based on second generation camelid single-domain antibody technology that holds several advantages over traditional IgG monoclonal antibodies
  • Improved potency and enhanced binding affinity
  • Similar preclinical safety profile
  • Commercial manufacturing capabilities through arrangement with Cytovance
  • Proprietary patented molecule, which unlike GTB-3550, is wholly owned by GT Biopharma

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