On September 22, 2020 GT Biopharma, Inc. (OTCQB:GTBP)(GTBP.PA) an immuno-oncology company focused on innovative therapies based on the Company’s proprietary NK cell engager (TriKE) technology reported it completed treatment of the first patient enrolled at Dose Level 3 in its GTB-3550 TriKE Phase I/II clinical trial (Press release, GT Biopharma, SEP 22, 2020, View Source [SID1234565471]).
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The first patient treated with GTB-3550 at a 25mcg/kg/day dose showed a decrease in AML blast levels from 18% to 12% in the bone marrow. Additionally, we observed an increase in the patient’s NK cell activity and numbers attributable to the IL-15 component of the TriKE molecule with no appreciable increase of a hyper-active T-cell population which could have resulted in cytokine release syndrome (CRS) or other T-cell associated toxicities. The patient experienced no adverse reactions including no constitutional symptoms such as fever, tachycardia, or chills. We also observed improvement in marrow cellularity, a decrease in AML blast levels, and improving platelet and red blood cells numbers. The patient will be retreated with an additional round of GTB-3550 therapy at the 25mcg/kg/day dose.
The open-label, dose-escalation Phase I portion of the trial will evaluate GTB-3550 in patients with CD33-expressing, high risk myelodysplastic syndromes, refractory/relapsed acute myeloid leukemia (AML) or advanced systemic mastocytosis, and will determine safety and tolerability as well as the pharmacologically active dose and maximum tolerated dose of GTB-3550. The Phase II portion of the trial is planned to further evaluate the efficacy of GTB-3550 in this patient population.
Mr. Anthony Cataldo, the Chairman and Chief Executive Officer of GT Biopharma commented "we are pleased to see a reduction in AML blast levels at a dose of 25mcg/kg/day of GTB-3550." Mr. Cataldo further stated "we hope to see the continued absence of toxicity, and see additional signals of efficacy as we continue to dose escalate GTB-3550."