GTB-5550 Phase 1 dose escalation basket trial expected to initiate mid-2026 Phase 1 protocol allows multiple solid tumor types known to express B7-H3 Unaudited proforma cash balance as of January 31, 2026 of approximately $9 million anticipated to extend cash runway through Q4 2026 SAN FRANCISCO, CALIFORNIA, Feb. 03, 2026 (GLOBE NEWSWIRE) — GT Biopharma, Inc. (the “Company”) (NASDAQ: GTBP), a clinical stage immuno-oncology company focused on developing innovative therapeutics based on the Company’s proprietary TriKE® natural killer (NK) cell engager platform, today 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.
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Brief Summary
GT Biopharma, Inc. (NASDAQ: GTBP) has announced the FDA’s clearance of their IND application for GTB-5550, marking a significant milestone in the development of innovative immunotherapies.
The upcoming Phase 1 trial, set to launch in mid-2026, will explore:
- Targeting B7-H3 expression in solid tumors.
- Inclusion of multiple solid tumor types.
- Estimated cash runway through Q4 2026 with a balance of approximately $9 million.
This advancement follows the FDA’s approval of two other TriKE® IND applications, emphasizing GT Biopharma’s commitment to pioneering cancer therapies. GTB-5550 seeks to enhance treatment options for patients with solid tumors expressing B7-H3.
Why it matters: This development could significantly expand GT Biopharma’s market potential and provide new therapeutic avenues for patients suffering from solid tumors.
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