GT Biopharma Inc（GTBP）のニュースとイベントGTBPGT Biopharma Inc

GT Biopharma Receives FDA Clearance for GTB-5550 IND Application

GT Biopharma announced FDA clearance of its IND application for GTB-5550, allowing the company to proceed with a Phase 1 clinical trial, which is anticipated to initiate in mid-2026. "FDA clearance of our third TriKE IND, GTB-5550, represents a defining moment for GT Biopharma as we bring another NK cell engager into the clinic", said Michael Breen, Executive Chairman and Chief Executive Officer of GT Biopharma. "We expect to commence enrollment of the Phase 1 basket trial in mid-2026. While the phase I trial is open to patients with common solid tumors that express B7-H3, in the dose-escalation component we will prioritize enrollment for advanced prostate, ovarian, and pancreatic cancer patients who have failed standard therapies. Based on the encouraging trends we have seen from our ongoing Phase 1 trial with GTB-3650 in AML patients, we are even more enthusiastic about the potential benefits of GTB-5550 treatment in patients with solid tumors known to express B7-H3."

GT Biopharma Submits IND Application for GTB-5550

GT Biopharma announced the submission of an investigational new drug, IND, application to the U.S. Food and Drug Administration, FDA, in December 2025 for GTB-5550 TriKE, a B7-H3-targeted natural killer cell engager for the treatment of B7-H3 expressing solid tumor cancers.