GT Biopharma Announces Interim GTB-3550 Trike™ Monotherapy Clinical Trial Results At 2021 Raymond James Human Health Innovation Conference
57% of patients experienced significant reduction in AML/MDS cancer cell burden
BEVERLY HILLS, Calif., June 23, 2021 /PRNewswire/ -- GT Biopharma (NASDAQ: GTBP), a clinical stage immuno-oncology company focused on developing innovative therapeutics based on the Company's proprietary NK cell engager (TriKE™) protein biologic technology platform, announced Jeffrey S. Miller, M.D., Deputy Director of the Masonic Cancer Center and Consulting Chief Scientific Officer, provided an update concerning GTB-3550 TriKE™ monotherapy clinical trial interim results at the 2021 Raymond James Health Innovation Conference. The presentation will be available on the "News & Media" page of the GT Biopharma website at www.gtbiopharma.com/news-media/presentation.
Highlights to date from patients treated with GTB-3550 TriKE™ monotherapy in the dose escalation Phase 1 clinical trial for the treatment of high-risk MDS and refractory/relapsed AML:
The on-going Phase 1 clinical trial of GTB-3550 TriKE™ monotherapy is focused on evaluating safety, and the determination of the recommended Phase 2 dose (RP2D), dose schedule and the maximum tolerated dose (MTD). Additional information is being collected concerning anti-tumor activity against CD33+ acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) cancer cells, and restoration of the patient's exhausted/inhibited endogenous NK cell population. To date, 11 patients have completed treatment in the GTB-3550 Phase 1 clinical trial. Patient 5, Patient 7, Patient 9, Patient 11 experienced 33%, 61%, 63% and 50% reduction in CD33+ AML/MDS bone marrow blast levels, respectively. The Phase 1 safety part of the study is expected to conclude in late August 2021 with data publication currently scheduled for end of September 2021.
"We continue to be pleased with the safety profile of GTB-3550, and its ability to restore function of the patient's NK cells without the need for the administration of ex vivo engineered NK cells", said Anthony Cataldo, GT Biopharma's Chairman and Chief Executive Officer. "We have now completed treatment of eleven patients. In addition to strong safety results, we have seen significant reductions in CD33+ cancer cells in four of the last seven patients (57%) treated with doses of GTB-3550 ranging from 25mcg/kg/day to 150mcg/kg/day. This early sign of CD33+ target-specific cancer cell killing is very encouraging as we begin to focus on transitioning to the expanded efficacy part of the current GTB-3550 clinical trial", Mr. Cataldo further stated.
About High-Risk Myelodysplastic Syndromes
About Acute Myeloid Leukemia
About GTB-3550 TriKE™
About GTB-3550 TriKE™ Clinical Trial
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SOURCE GT Biopharma, Inc.
Company Codes: NASDAQ-NMS:GTBP