About GT Biopharma, Inc.
GT Biopharma, Inc. is a clinical-stage immuno-oncology company focused on developing innovative therapies based on its proprietary NK cell engager (TriKE®) technology. The company’s TriKE® therapeutic agents are targeted immunotherapeutic agents designed to simultaneously interact with natural killer (NK) cells and cancer cells. This dual engagement is intended to facilitate the selective killing of cancer cells through immune-mediated mechanisms.
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Advancement of the GTB-3650 Phase 1 Trial
During 2025, GT Biopharma reported continued progress in its Phase 1 dose-escalation trial of GTB-3650, with the study advancing safely through early cohorts and clearing required safety reviews to proceed into higher dosing levels.
Immune Activation Signals Observed in Early Cohorts
The company disclosed that patients treated in early cohorts demonstrated immune activation signals consistent with engagement of the intended NK-cell–based mechanism, supporting further dose escalation and continued study progression.
Progression Into Higher Dose Cohorts Following Late-2025 Escalation
GT Biopharma entered Cohort 4 dosing in late 2025, representing a higher exposure level within the GTB-3650 Phase 1 study. Advancement into higher dose ranges is a meaningful step in early-stage oncology trials and sets the stage for additional clinical insights as the trial continues into 2026.
Planned Clinical Update in Q1 2026
The company has stated that it expects to provide its next update on the GTB-3650 Phase 1 trial in the first quarter of 2026, positioning the program for a near-term data event early in the year.
GT BIOPHARMA, INC
(NASDAQ: gtbp)
pRODUCT PIPELINE
The TriKE® Platform Advantage
At the core of GT Biopharma is a proprietary Tri-specific Killer Engager (TriKE®) platform designed to engage the CD16 Fc receptor on natural killer (NK) cells, target tumor-specific antigens, and incorporate an IL-15 moiety to induce NK cell proliferation and activation. This multi-component design brings immune activation and tumor targeting together within a single therapeutic construct.
The platform is based on second-generation TriKE® molecules, which have demonstrated 10–40× greater potency compared to first-generation TriKE® constructs. As a result, all current and future development efforts are focused exclusively on this second-generation TriKE® platform.
Platform Versatility and Expansion Potential
GT Biopharma’s TriKE® technology is designed as a modular platform that can be applied to any known or proprietary tumor target, as well as other disease targets, including infectious disease reservoirs such as HIV. Multiple TriKE® candidates are either in research development or planned, supporting a pipeline approach rather than reliance on a single asset.
TriKE® Clinical Pipeline
GTB-3650 TriKE®
GTB-3650 is the company’s first second-generation TriKE® to enter clinical testing and the first TriKE® to utilize camelid nanobody technology. It is being evaluated for the treatment of CD33-positive leukemias, including acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS).
GTB-3650 is a tri-specific molecule composed of:
- A camelid nanobody targeting CD16 on NK cells
- A single-chain variable fragment (scFv) recognizing CD33 on tumor cells
- Human wild-type IL-15
The IND application was cleared and patient enrollment began on January 21, 2025. As of July 2025, the company anticipated enrollment into Cohort 3 following a successful safety review of Cohort 2. Biomarker analyses from patients in Cohorts 1 and 2 demonstrated evidence of increased immunologic activity, supporting the ability of GTB-3650 to activate endogenous NK cells and induce NK cell expansion.
The Phase 1 trial is designed to evaluate GTB-3650 across up to seven dose cohorts, with dosing administered as 72-hour continuous infusions in two-week on/off cycles for up to four months based on clinical benefit. Endpoints include safety, pharmacokinetics, pharmacodynamics, in vivo NK cell expansion, and clinical activity. (ClinicalTrials.gov Identifier: NCT06594445)
GTB-5550 TriKE®
GTB-5550 is in development for the treatment of B7H3-positive solid tumors. It is the first dual camelid engager TriKE® and is composed of:
- A camelid nanobody targeting CD16 on NK cells
- A proprietary camelid nanobody targeting B7H3
- Human wild-type IL-15
Preclinical data support activity across multiple solid tumor types. Clinical material has been manufactured and is scheduled for vialing, with FDA submission planned for Q4 2025. GTB-5550 is expected to be the first TriKE® evaluated using subcutaneous dosing, with an initial clinical trial planned across several solid tumors including breast, lung, ovarian, head and neck, pancreatic, bladder, and prostate cancers. Additional preclinical studies are ongoing in multiple myeloma and brain tumors.
GTB-7550 TriKE®
GTB-7550 is being developed for CD19-positive lymphoid malignancies and autoimmune disease. The molecule consists of:
- A camelid nanobody binding CD16 on NK cells
- An scFv derived from an anti-CD19 antibody
- Human wild-type IL-15
GTB-7550 has demonstrated preclinical activity in published models of lymphoma and chronic lymphocytic leukemia. Based on early activity against normal B-cells, development is also underway in autoimmune disease. Manufacturing bids for clinical material are being evaluated, with production planned in 2026 and FDA submission expected thereafter.
GTB-3550 TriKE® (Discontinued)
GTB-3550 was GT Biopharma’s first-generation TriKE® evaluated in a Phase 1 trial for relapsed/refractory AML and high-risk MDS. The molecule demonstrated safety, tolerability, and clinical proof-of-concept for in vivo activity. Following these results, the first-generation platform was discontinued in favor of the more potent second-generation TriKE® platform utilizing camelid nanobody technology and wild-type IL-15.
Introducing the Management Team of GT Biopharma, Inc. (GTBP)
Michael Breen
Executive Chairman, Board of Directors, Chief Executive Officer
Michael Breen is an English qualified solicitor/attorney and was formerly the Managing Director of the Sports and Entertainment Division of Bank Insinger de Beaufort N. V., which is a wealth management organization and was part of BNP Paribas Group, one of the world's largest banks. The holding company Insinger de Beaufort Holdings S.A. was listed on the Luxembourg Stock Exchange. Mr. Breen was also a director and major shareholder of an affiliate of Insinger de Beaufort Holdings S.A.
Mr. Breen is a former senior equity partner in the 400+ partner and 50+ office law firm of Clyde & Co, whose head office is based in the City of London, England.
Jeffrey S. Miller, M.D.
Consulting Senior Medical Director
Jeffrey S. Miller, MD, received a Bachelor of Science degree from Northwestern University in Evanston, Illinois and received his MD from Northwestern University School of Medicine. He completed an internship and residency in Internal Medicine at the University of Iowa in Iowa City. After completing a post-doctoral fellowship in Hematology, Oncology and Transplantation at the University of Minnesota, he joined the faculty in 1991. Dr. Miller is currently a Professor of Medicine at the University of Minnesota. He is the Interim Director of the University of Minnesota Masonic Cancer Center. He has more than 20 years of experience studying the biology of NK cells and other immune effector cells and their use in clinical immunotherapy with over 170 peer-reviewed publications. He is a member of numerous societies such as the American Society of Hematology, the American Association of Immunologists, a member of the American Society of Clinical Investigation since 1999. He serves on the editorial board for Blood and is a reviewer for a number of journals and NIH grants.
Alan L. Urban
Chief Financial Officer
Alan Urban has over 30 years of corporate finance and accounting experience for a variety of public and private companies. Most notably Mr. Urban served as a member of the board of directors of GT Biopharma, Inc. (NASDAQ: GTBP), from mid-2022 to mid-2023; and as Chief Financial Officer for Research Solutions, Inc. (NASDAQ: RSSS), a SaaS and content provider in the scientific, technical and medical information space, for over a decade from 2011 to 2021. Earlier in his career, Mr. Urban served as Chief Financial Officer for ReachLocal, Inc. (formerly NASDAQ: RLOC), an internet marketing company; and as Vice President of Finance for Infotrieve, Inc., a content provider in the scientific, technical and medical information space. Mr. Urban has been a Certified Public Accountant (currently inactive) since 1998, and received a B.S. in Business, with a concentration in Accounting Theory and Practice, from California State University, Northridge.
Sources
- https://www.gtbiopharma.com/
- https://finance.yahoo.com/quote/GTBP/
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