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GT Biopharma passes IRB & CPRC approvals to launch human Phase 1 clinical trial of GTB-3550 for AML, MDS and mastocytosis.

M2 EQUITYBITES-April 9, 2019-GT Biopharma passes IRB & CPRC approvals to launch human Phase 1 clinical trial of GTB-3550 for AML, MDS and mastocytosis


Biotechnology company GT Biopharma Inc (OTCQB:GTBP) (GTBP.PA) reported on Monday the receipt of approval from the University of Minnesota's Institutional Review Board (IRB) and Cancer Protocol Review Committee (CPRC) to initiate its first-in-human Phase 1 study with GTB-3550 for the treatment of acute myelogenous leukaemia (AML), myelodysplatic syndrome (MDS) and mastocytosis.

The company added that the study will be led by Principal Investigator, Erica Warlick, MD, associate professor of medicine, Division of Hematology, Oncology and Transplantation at Masonic Cancer Center, University of Minnesota.

GTB-3550 (OXS-3550), the company's first Tri-specific Killer Engager (TriKE) product candidate. 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. When the NK stimulating cytokine human IL-15 is used as a crosslinker between the two scFvs, it provides a self-sustaining signal that activates NK cells and enhances their ability to kill.

This single centre, first-in-human Phase 1 clinical trial of GTB-3550 will enrol up to 60 subjects with CD33-expressing high risk for refractory/relapsed AML, MDS, or advanced systemic mastocytosis. Subjects will receive a single course of GTB-3550 TriKE given as three weekly treatment blocks. The primary objective will be to identify the maximum tolerated dose (MTD) of GTB-3550 TriKE defined as the dose level that most closely corresponds to a dose limiting toxicity rate (DLT) of 20%.

AML is the most common form of adult leukaemia with 21,000 new cases expected in 2018 alone. Myelodysplastic syndromes (MDS) are conditions that can occur when the blood-forming cells in the bone marrow become abnormal, leading to low numbers of one or more types of blood cells. Mastocytosis is a rare disorder characterised by abnormal accumulations of mast cells in the skin, bone marrow and internal organs (liver, spleen, gastrointestinal tract and lymph nodes).

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Publication:M2 EquityBites (EQB)
Date:Apr 9, 2019
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