GT Biopharma Announces IND Submission for GTB-5550 TriKE®, a B7-H3-targeted natural killer (NK) cell engager for B7-H3 expressing solid tumor cancers

GT Biopharma targets a portion of the estimated $362 billion global solid tumor market

Preliminary, unaudited cash balance of approximately $7 million as of December 31, 2025 anticipated to extend cash runway into Q3 2026

Excerpt from the Press Release:

SAN FRANCISCO, CALIFORNIA, Jan. 15, 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 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 (NK) cell engager for the treatment of B7-H3 expressing solid tumor cancers.

“The IND for GTB-5550 represents another NK cell engager we plan to move into clinical development and a tremendous accomplishment for the company”, said Michael Breen, Executive Chairman and Chief Executive Officer of GT Biopharma. “As we continue actively enrolling the Phase 1 trial with GTB-3650 in myeloid blood cancer, we expect the next data readout in 1H 2026 could provide potential evidence of clinical activity. Initiation of a Phase 1 basket trial with GTB-5550 for multiple solid tumors is planned for 2026. We look forward to applying the clinical learnings from the GTB-3650 study to help inform the GTB-5550 program, which targets a patient population with B7-H3 expressing solid tumors that is orders of magnitude larger than the myeloid blood cancer patient population.” The global market for B7-H3 expressing solid tumor cancers accounts for a portion of the estimated $362 billion global solid tumor cancers market (according to Data Bridge Market Research). B7-H3 expressing solid tumor cancers are estimated to account for a significant portion of solid tumor cancers.

GTB-5550 is a camelid (cam) anti-CD16/WT IL-15/cam anti-B7-H3 tri-specific natural killer (TriKE) cell engager, with a single chain recombinant TriKE comprised of three components joined by flexible linkers: 1) a nanobody arm that engages the CD16 activating receptor (camelid anti-CD16) on natural killer (NK) cells; 2) a wildtype IL-15 (WT IL-15) linker arm to drive NK cell proliferation, priming, and survival; and 3) a nanobody arm that specifically engages B7-H3 (camelid anti-B7-H3) to target the antigen expressed on tumor cells.

Click the button below to read the entire Press Release:

Continue Reading The Press Release