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GT Biopharma Announces GTB-3550 TriKE(TM) Reduces Bone Marrow Blast Levels, Improves NK Cell Function and Proliferation, and No Toxicities Observed in AML and MDS Patients
GTB-3550 Interim Results Presented at 62nd American Society of Hematology Annual Meeting and ExpositionBEVERLY HILLS, CA / ACCESSWIRE / December 8, 2020 / GT
About this update from Gt Biopharma, Inc.
[{"type":"text","content":"GTB-3550 Interim Results Presented at 62nd American Society of Hematology Annual Meeting and ExpositionBEVERLY HILLS, CA / ACCESSWIRE / December 8, 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 platform is pleased to announce the presentation of interim results for the Company's lead therapeutic candidate, GTB-3550 for the treatment of high-risk myelodysplastic syndromes (MDS) and refractory/relapsed acute myeloid leukemia (AML). Erica Warlick, M.D, the Principal Investigator for the GTB-3550 clinical trial, presented the interim results during an Oral Session at the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition on December 5, 2020. Dr. Warlick's presentation can be viewed on the GT Biopharma web site at https://ir.gtbiopharma.com/presentations.Reduction in Bone Marrow Blast Levels AchievedTo date, 7 patients have been enrolled, two at 5 mcg/kg/day, two at 10 mcg/kg/day, two at 25 mcg/kg/day, and one at 50 mcg/kg/day. All seven patients (5-50 mcg/kg/day) have completed therapy. The first patient treated at 5 mcg/kg/day had stable disease after GTB-3550 therapy, and the first patient treated at 25 mcg/kg/day saw AML blast levels decrease from 18% to 12% after GTB-3550 therapy.Patient #7, a high-risk MDS patient who had failed hypomethylating agent (HMA) and Luspatercept therapies, treated with GTB-3550 at 50mcg/kg/day (three consecutive 96-hour continuous infusions) achieved a bone marrow blast level reduction from 12% to 4.6% and stable hematologic parameters including normal platelet counts throughout therapy. Following this single course of GTB-3550 therapy, Patient #7 now meets criteria for a bone marrow transplant that is planned for next week.No Toxicities ObservedPatients treated with GTB-3550 TriKE displayed no signs of clinical immune activation such as cytokine release syndrome (CRS) or serious adverse events (SAEs) or fevers, tachycardia or constitutional symptoms at any dose (5-50mcg/kg/day) evaluated to date. Of particular note, GTB-3550 is currently being administered to patients at 25x the previous reported MTD for continuous infusion of recombinant human IL-15 (Waldmann, TA et al, Clin Cancer Res. (2019) 25:4945-54). GTB-3550 is a single-chain, tri-specific s...