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GT Biopharma Announces Potential New Indication for GTB-5550, a B7-H3-Targeted Natural Killer (NK) Cell Engager, for Multiple Myeloma
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GT Biopharma, Inc.
TriKE NK Cell Engager Platform
- GT Biopharma’s TriKE drugs are designed to direct a patient’s own natural killer (NK) cells to kill cancer cells by forming an immune synapse between the NK cell and the tumor cell.
- Each TriKE is a single-chain fusion protein with three parts: a CD16 binding arm for NK cells, an IL-15 segment that drives NK cell proliferation and survival, and a tumor targeting arm.
- The first generation candidate, GTB-3550, completed Phase 1, and an interim result from that small study showed CD33 positive bone marrow blast reductions ranging from 33.3% to 63.6% in four patients.
- The platform can be engineered to target many tumor antigens, with current clinical programs including:
- GTB-3650 → CD33, relapsed or refractory AML and high-risk MDS
- GTB-5550 → B7-H3, solid tumors and multiple myeloma
- Second generation TriKEs use a camelid nanobody, and the company states they are 10 to 40 times more potent than first generation TriKEs.
Operational Momentum and Scaling
- GT Biopharma runs as a virtual, licensing-based drug developer with one full-time employee, relying on consultants, the University of Minnesota, and contract manufacturers including Cytovance Biologics.
- GTB-3650 completed Cohort 4 and was enrolling Cohort 5 as of August 14, 2026, in a dose escalation study of up to 7 cohorts and 14 patients.
- GTB-5550 completed Cohort 1 and was enrolling Cohort 2 in its solid tumor Phase 1 trial as of August 14, 2026, with an update expected in Q4 2026.
Positioning for Long-Term Growth
- The company expects multiple AI-assisted candidates to enter pre-IND development in 2027, possibly beyond oncology.
- GTB-7550, a preclinical CD19 TriKE, targets B-cell malignancies and autoimmune disease, including lupus.
- The company says its candidates can be advanced on its own or through potential collaborations with partner companies, although no partnership deal has been announced.
Introducing the Leadership Team of GT Biopharma, Inc.(Nasdaq: GTBP)
Michael Breen
Executive Chairman and Chief Executive Officer
Michael Breen serves as Executive Chairman and Chief Executive Officer of GT Biopharma. He is an English qualified solicitor and previously served as Managing Director of the Sports and Entertainment Division of Bank Insinger de Beaufort N.V., then part of BNP Paribas Group. Earlier in his career, he was a senior equity partner at the law firm Clyde & Co in London.
Alan L. Urban
Chief Financial Officer
Alan L. Urban brings more than 30 years of corporate finance and accounting experience to GT Biopharma. He previously served on the company's board of directors from mid-2022 to mid-2023.
Prior to joining GT Biopharma, Mr. Urban served as Chief Financial Officer of Research Solutions (NASDAQ: RSSS) from 2011 to 2021 and was formerly Chief Financial Officer of ReachLocal. He has been a CPA (inactive) since 1998 and holds a B.S. from California State University, Northridge.
Jeffrey S. Miller, M.D.
Consulting Senior Medical Director
Dr. Jeffrey S. Miller is a Professor of Medicine at the University of Minnesota and Interim Director of its Masonic Cancer Center, where he led the original TriKE program. He has more than 20 years of experience studying NK cell biology, has authored more than 170 peer-reviewed publications, and serves on the editorial board of Blood. He received his M.D. from Northwestern University.
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Sources
[COMPANY WEBSITE URL]https://www.sec.gov/ (GTBP SEC Filings)[COMPANY WEBSITE URL] (Press Releases)https://robinhood.com/ (Market Data, Oct 9, 2026)
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