GT Biopharma(US:GTBP) Globenewswire·2026-01-15 13:30Core Insights - GT Biopharma is targeting a segment of the estimated $362 billion global solid tumor market with its investigational drug GTB-5550, a B7-H3-targeted NK cell engager [1][2] - The company has submitted an IND application to the FDA for GTB-5550, which is expected to enter clinical trials in 2026 [1][2] - The company anticipates a cash balance of approximately $7 million as of December 31, 2025, which is expected to extend its cash runway into Q3 2026 [1] Company Overview - GT Biopharma is a clinical stage biopharmaceutical company focused on developing immuno-oncology therapeutics based on its proprietary TriKE NK cell engager platform [6] - The company has an exclusive worldwide license agreement with the University of Minnesota to further develop and commercialize therapies using TriKE technology [6] Product Development - GTB-5550 is a tri-specific NK cell engager designed to enhance the cancer-killing abilities of NK cells by targeting B7-H3 expressed on tumor cells [3] - The planned Phase 1 trial for GTB-5550 will be the first dual nanobody TriKE tested with subcutaneous dosing, aiming to identify the maximum tolerated dose (MTD) across various metastatic cancers [4] - The trial will include a dose escalation phase and a dose expansion phase, evaluating tolerability and efficacy in multiple solid tumor cohorts [4][5] Market Potential - The global market for B7-H3 expressing solid tumor cancers is a significant portion of the overall solid tumor market, indicating a large potential patient population for GTB-5550 [2]