GT Biopharma, Inc. (NASDAQ: GTBP) is a clinical-stage biopharmaceutical company focused on the development of innovative natural killer (NK) cell engager therapies for the treatment of cancer. The company’s proprietary pipeline centers on Bispecific and Trispecific Killer Engagers (BiKE® and TriKE®) designed to harness and enhance the body’s innate immune system by directing NK cells to recognize and kill tumor cells. GT Biopharma is advancing its lead candidate, GTB-3550, a TriKE targeting CD33-positive hematologic malignancies, through Phase 1/2 clinical trials in patients with acute myeloid leukemia (AML) and other myeloid disorders.
Founded in 2008 and headquartered in Houston, Texas, GT Biopharma has built a robust preclinical and clinical portfolio that leverages expertise in antibody engineering and cell therapy. In addition to GTB-3550, the company is developing next-generation TriKE constructs aimed at solid tumors, including molecules that target antigens such as HER2 and EGFR. These programs are positioned to address significant unmet medical needs by offering off-the-shelf immunotherapy options without the complexity or cost associated with patient-specific cell manufacturing.
GT Biopharma operates a centralized research and manufacturing facility in Houston, which supports both discovery and scale-up activities. The company collaborates with academic institutions and contract research organizations across North America to accelerate clinical development and optimize manufacturing processes. GT Biopharma’s approach emphasizes modular design, enabling rapid adaptation of its engager platform to emerging tumor targets and combination strategies with existing immunotherapies.
The leadership team is spearheaded by President and CEO Alan J. Lewis, whose background spans oncology drug development and strategic licensing partnerships. Under his guidance, GT Biopharma has expanded its executive ranks and board of directors to include industry veterans with extensive experience in immuno-oncology, clinical operations, and regulatory affairs. Together, the team is focused on advancing the company’s clinical candidates through pivotal studies with the goal of delivering transformative therapies to cancer patients worldwide.
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