GT Biopharma, Inc. is a biopharmaceutical company in the clinical development phase, dedicated to discovering and bringing to market novel immuno-oncology treatments. ...
GTB-3650 is a second-generation tri-specific killer engager (TriKE) molecule utilizing camelid nanobody technology. It consists of a camelid nanobody binding to the CD16 receptor on NK cells, a single-chain variable fragment (scFv) targeting CD33 on tumor cells, and human wild-type IL-15 to promote NK cell proliferation and survival. It is currently in a Phase 1 dose-escalation clinical trial for relapsed or refractory CD33-expressing hematologic malignancies.
Price Range: N/A (Clinical stage, not commercially available)
Pain Points: Addressing limitations in existing treatments for relapsed/refractory hematologic malignancies where tumor-specific antigen targeting is required.
Solutions: Provides targeted engagement of NK cells to tumor sites while simultaneously driving the proliferation and activation of the body's natural killer cells to eliminate cancer.
Target Users: Healthcare providers and patients suffering from CD33-positive leukemias including AML and high-risk MDS.
Supply Chain
Internal R&D and platform technologyLicense agreement with the Regents of the University of MinnesotaContract manufacturing organizations (CMOs) for clinical supplies
GTB-5550 is a second-generation TriKE featuring two camelid nanobodies—one for CD16 on NK cells and one for the B7-H3 tumor antigen—linked by wild-type IL-15. It is designed for patient-friendly subcutaneous injection and is undergoing a Phase 1 basket trial for metastatic solid tumors, including prostate, ovarian, breast, head and neck, non-small cell lung, pancreatic, and bladder cancers.
Price Range: N/A (Clinical stage, not commercially available)
Pain Points: The need for effective, potent, and patient-convenient immunotherapies for solid tumors that overexpress B7-H3.
Solutions: Combines tumor-specific targeting with enhanced NK cell expansion and activation via a convenient subcutaneous dosing regimen.
Target Users: Healthcare systems and patients with advanced metastatic solid tumors expressing the B7-H3 antigen.
Supply Chain
Internal R&D and platform technologyLicense agreement with the Regents of the University of MinnesotaContract manufacturing organizations (CMOs) for clinical supplies
GTB-7550 is a tri-specific molecule composed of a camelid nanobody binding CD16, an anti-CD19 scFv, and human wild-type IL-15. While initially tested for lymphomas and chronic lymphocytic leukemia, the platform's ability to target normal B-cells is being explored for applications in autoimmune disease.
Price Range: N/A (Preclinical stage)
Pain Points: Addresses the need for potent, targeted therapies for B-cell malignancies and the depletion of problematic B-cells in autoimmune disorders.
Solutions: Utilizes the NK cell engagement platform to selectively target CD19-positive cells while boosting the patient's innate immune response.
Target Users: Oncology and immunology clinical research settings.
Supply Chain
Internal R&D and platform technologyLicense agreement with the Regents of the University of Minnesota
GTB-3550 was the company's first-generation TriKE, a recombinant fusion protein consisting of scFv antibodies for CD16 and CD33 with a mutant IL-15. It successfully demonstrated safety and proof-of-concept in clinical trials for AML and MDS but has been superseded by the more potent second-generation camelid-based TriKE pipeline.
Price Range: N/A (Discontinued)
Pain Points: Established the initial safety and feasibility of the TriKE platform for treating hematologic cancers.
Solutions: Provided clinical data supporting the further development of the second-generation, more potent TriKE platform.
Target Users: Historical clinical trial participants and research databases.
