GT Biopharma(US:GTBP) Globenewswire·2026-02-03 13:30Core Insights - GT Biopharma has received FDA clearance for its IND application for GTB-5550, allowing the initiation of a Phase 1 clinical trial expected to start in mid-2026 [1][2] - The Phase 1 trial will focus on multiple solid tumor types expressing B7-H3, with a priority on advanced prostate, ovarian, and pancreatic cancer patients who have failed standard therapies [2][3] - The company anticipates an unaudited proforma cash balance of approximately $9 million as of January 31, 2026, which is expected to extend its cash runway through Q4 2026 [1] Company Overview - GT Biopharma is a clinical stage immuno-oncology company that develops therapeutics based on its proprietary TriKE NK cell engager platform [5] - The TriKE platform aims to enhance the cancer-killing abilities of natural killer cells in the immune system [5] - The company has an exclusive worldwide license agreement with the University of Minnesota for the development and commercialization of therapies using TriKE technology [5] Clinical Trial Details - The Phase 1 trial will include a dose escalation component testing up to 6 dose levels to identify the maximum tolerated dose (MTD) [3] - Following the dose escalation, a Phase 1b expansion will confirm the MTD in various metastatic disease cohorts, including castration-resistant prostate cancer and others [3] - GTB-5550 will be administered via subcutaneous injection for 5 consecutive days during the first two weeks of each 4-week treatment cycle, with patient follow-up for 12 months to assess progression-free survival and overall survival [4]