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Three Cancer Drugs Have Reached the Clinic: Inside GT Biopharma's TriKE Bet

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  • GT Biopharma Inc (NASDAQ: GTBP) has advanced three TriKE® candidates into human testing: GTB-3550, GTB-3650, and GTB-5550.
  • The company's active clinical programs are currently GTB-3650 and GTB-5550, with GTB-3650 replacing the earlier GTB-3550 program.
  • On May 14, 2026, the first patient was dosed in a Phase 1 trial of GTB-5550, marking the first expansion of the company's pipeline into solid tumors.
  • GTB-5550 is a B7-H3-targeted natural killer (NK) cell engager designed to treat a range of advanced solid tumors.
  • The lead program GTB-3650 is a second-generation camelid-nanobody TriKE in a Phase 1 dose-escalation trial for relapsed or refractory CD33-expressing hematologic malignancies, including acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS).
  • The GTB-3650 trial evaluates approximately 14 patients across seven dose cohorts, with dosing blocks of two weeks on and two weeks off.
  • GT Biopharma utilizes a proprietary TriKE® platform licensed from the University of Minnesota to connect NK cells to cancer targets while delivering an interleukin-15 signal for cell expansion.
  • The company maintains a modest market capitalization relative to other clinical-stage oncology peers despite having multiple assets in human trials.
  • GTB-7550 remains an earlier-stage candidate for CD19-positive lymphoid malignancies and autoimmune disease.
  • GTB-5550 is being tested in a basket trial to assess efficacy across multiple tumor types simultaneously.
  • Peer companies in the NK-cell and immuno-oncology space include Nkarta Inc (NASDAQ: NKTX), Iovance Biotherapeutics Inc (NASDAQ: IOVA), Fate Therapeutics Inc (NASDAQ: FATE), and ImmunityBio Inc (NASDAQ: IBRX).
  • Michael Breen serves as Executive Chairman and Chief Executive Officer of GT Biopharma.
  • The article notes that while the platform shows engineering progression, clinical success is not guaranteed, and the company faces ongoing capital needs.