GT Biopharma Announces Update On The Commencement Of The GTB-3550 TriKE™ Monotherapy Phase 2 Clinical Trial And Solid Tumor TriKE™ Product Candidates

About this update from Gt Biopharma, Inc.

[{"type":"text","content":"BEVERLY HILLS, Calif., May 12, 2021 /PRNewswire/ -- GT Biopharma, Inc. (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, is pleased to provide an update concerning the commencement of the GTB-3550 TriKE™ monotherapy Phase 2 clinical trial, and certain of its solid tumor targeting TriKE™ product candidates.\n\n \n \n \n \n \n \n\n \nHighlights to date from patients treated with GTB-3550 TriKE™ in the dose escalation Phase 1 clinical trial for the treatment of high-risk myelodysplastic syndromes (MDS) and refractory/relapsed acute myeloid leukemia (AML):\nUp to 63.7% Reduction in Bone Marrow Blast Levels seen in some patients. Restoration of Patient's Endogenous NK Cell Function, Proliferation and Immune Surveillance. No Progenitor-derived or Autologous/Allogenic Cell Therapy Required. No Cytokine Release Syndrome Observed. While the design of the Phase 1 part of the GTB-3550 clinical trial was focused on evaluating safety, indications of anti-tumor activity during Phase 1 have resulted in a refocusing of the Phase 2 design of the clinical trial towards enhancing efficacy, durability of the clinical response, and overall survival with the goal to seek accelerated approval from FDA. We intend to (i) enroll patients with CD33 expression ≥50% in two independent cohorts (higher-risk myelodysplastic syndrome and acute myeloid leukemia); (ii) treat patients with two cycles of GTB-3550 therapy with a rest period between cycles as opposed to the single-cycle used during Phase 1; (iii) enroll patients with fewer prior treatment lines; and, (iv) evaluate the potential use of minimal residual disease (MRD) based endpoints that may allow for accelerated approval. \nSolid tumor cancers present a significantly larger market opportunity than hematologic cancer indications, and represent the majority of new cancer diagnoses annually. The Company is presently advancing three TriKE™ product candidates in GMP manufacturing and early clinical development. These solid tumor TriKE product candidates will target cancers expressing HER2 (GTB-6550), PD-L1 (GTB-4550) and B7H3 (GTB-5550), and will be evaluated for the treatment of multiple cancers such as breast, lung, gastric, colorectal and ovarian. We beli...

More updates from Gt Biopharma, Inc.