GT Biopharma, Inc. is a biopharmaceutical company in the clinical development phase, dedicated to discovering and bringing to market novel immuno-oncology treatments. Their innovative approach centers on a proprietary technology platform called Tri-specific Killer Engager (TriKE) fusion proteins, which are designed to harness the body's immune cells. Central to their pipeline is GTB-3550, a single-chain tri-specific recombinant fusion protein conjugate currently undergoing Phase I/II clinical trials. This therapeutic candidate is being evaluated for its potential in treating myelodysplastic syndromes, acute myeloid leukemia that has relapsed or proven refractory to prior treatments, advanced systemic mastocytosis, and other malignancies expressing CD33. The company's research also includes GTB-3650, which is in preclinical development targeting CD33 on myeloid leukemias, and GTB-5550, another preclinical asset aimed at solid tumors that are positive for B7-H3. GT Biopharma has forged key collaborations, including a co-development agreement with Altor BioScience Corporation for the clinical advancement of a 161533 TriKE fusion protein for various cancer indications. Furthermore, they maintain a license agreement with the Regents of the University of Minnesota to develop and commercialize cancer therapies utilizing their TriKE technology. Founded in 1965, the company previously operated as OXIS International, Inc. before rebranding to GT Biopharma, Inc. in July 2017. Its corporate operations are based in Brisbane, California.
GT Biopharma Announces Potential New Indication for GTB-5550, a B7-H3-Targeted Natural Killer (NK) Cell Engager, for Multiple Myeloma
GT Biopharma received FDA clearance of a new IND for GTB-5550, its B7-H3-targeted TriKE NK cell engager, in multiple myeloma under an investigator-sponsored trial protocol with the University of Minnesota.
The planned Phase 1a/1b study would be the first-in-human trial of a B7-H3-targeted TriKE in multiple myeloma, using subcutaneous dosing with Phase 1a dose escalation in 4th-line-plus patients across up to 6 cohorts followed by a 25-patient Phase 1b expansion — but initiation is contingent on receipt of non-dilutive grant funding.
Separately, the Phase 1 solid tumor basket trial with GTB-5550 continues actively enrolling with an update anticipated in Q4 2026, and unaudited proforma cash of approximately $11 million as of September 15, 2026 is expected to provide runway into Q3 2027.