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Within this landscape, GT Biopharma (NASDAQ:GTBP) is advancing a proprietary platform designed to harness NK cells against cancer. Its main candidate, GTB 3650, is currently being tested in Phase 1 trials for patients with relapsed or refractory acute myeloid leukemia, and the company is also working on treatments Early clinical progress and multiple upcoming milestones position GTBP as a notable player in the evolving immuno-oncology market.
Advancing a Potent Platform
GTBP's TriKE platform focuses on NK cell engagers designed to activate and expand a patient's own immune cells. Second-generation TriKE molecules, built with camelid nanobody technology, are reported to be 10 to 40 times more potent than first-generation constructs. The lead program, GTB 3650, is undergoing a Phase 1 dose escalation study targeting CD33-positive hematologic malignancies, including AML and high-risk MDS. The FDA cleared t-positive2024, and enrollment began in January 2025.
Clear Progress in Early Cohorts
The trial includes up to seven cohorts, two patients each, with dose levels ranging from 1.25 µg/kg/day to 100 µg/kg/day. As of October 2025, all six patients in Cohorts 1 through 3 had been successfully treated. The Cohort 3 formal safety review revealed no tolerability issues. enabling progression to Cohort 4 at 10 µg/kg/day. Management described this dose as "more reflective of the potential efficacy threshold," citing positive trends in immunologic biomarkers.
Early cohorts also demonstrated increased NK cell activity, supporting the TriKE mechanism of immune activation and expansion. GTB 3650 is administered as a 72-hour continuous infusion in two-week blocks, allowing assessment of safety, pharmacokinetics, pharmacodynamics, NK cell expansion, and early clinical activity.
Pipeline Growth and Financial Health
GTB 5550, GTBP's B7H3-targeting TriKE, is preparing for an IND submission in late December 2025 or January 2026. This dual camelid nanobody design will use subcutaneous dosing, offering a more patient-friendly alternative to continuous infusion. Preclinical studies support activity against breast, lung, ovarian, pancreatic, bladder, prostate, and head and neck cancers.
Additionally, GTB 7550 targets CD19-positive lymphoid malignancies and autoimmune diseases and remains in preclinical development, with manufacturing plans underway for 2026. GTBP is building a pipeline that spans hematologic, solid tumor, and immune-mediated indications.
Financially, the company reported $2.6 million in cash as of Q3 2025, expected to fund operations into early 2026. R&D expenses decreased year-over-year, while SG&A costs remained stable, reflecting disciplined management during clinical advancement.
Posted In: GTBP
