GT Biopharma Advances To Dose Level 3 with TriKE(TM) FDA Phase I/II Clinical Trial
BEVERLY HILLS, CA / ACCESSWIRE / August 4, 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 announced today it had completed treatment of patients enrolled at Dose Levels 1 and 2, and begun enrolling patients for treatment at Dose Level 3, in its GTB-3550 TriKE™ Phase I/II clinical trial.
Following initial treatment, the first patient treated with GTB-3550 achieved stable disease with respect to the number of acute myeloid leukemia (AML) blasts observed in their bone marrow before and after treatment. Additionally, we observed an increase in the patient's total NK cell population attributable to the IL-15 component of the TriKE™ molecule with no appreciable increase of any hyper-active T-cell population. All patients treated to date with GTB-3550 have experienced no adverse reactions including no constitutional symptoms such as fever, tachycardia, or chills. Patients now being enrolled will be treated at a dose of 25µg/kg/day.
The clinical trial is being conducted at the Masonic Cancer Center, University of Minnesota under the direction of Dr. Erica Warlick. Additional clinical trial sites are being engaged in States that have modified their COVID-19 restrictions to allow for the restarting of clinical trials.
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 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 have advanced treatment to the next higher dose of GTB-3550." Mr. Cataldo further stated "we hope to continue to see additional signals of efficacy at the new higher dose of GTB-3550."
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 natural killer (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.
About GT Biopharma, Inc.
GT Biopharma, Inc. is a clinical stage biopharmaceutical company focused on the development and commercialization of immuno-oncology therapeutic products based our proprietary Tri-specific Killer Engager (TriKE™) platform. Our TriKE platform is designed to harness and enhance the cancer killing abilities of a patient's immune system natural killer cells (NK cells). GT Biopharma has an exclusive worldwide license agreement with the University of Minnesota to further develop and commercialize cancer therapies using proprietary TriKE technology developed by researchers at the university to target NK cells to cancer.
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SOURCE: GT Biopharma, Inc.
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Released August 4, 2020