GTB-5550 Enters Clinical Trials for Solid Tumors
Written by Emily J. Thompson, Senior Investment Analyst
Updated: May 14 2026
0mins
Source: Newsfilter
- Clinical Trial Launch: GT Biopharma announced that the first patient was dosed with GTB-5550 on May 14, 2026, focusing on prostate cancer patients, marking a pivotal expansion of the TriKE® platform into broader solid tumor treatments.
- Dose Escalation Study: The Phase 1 trial will evaluate up to 6 dose levels to determine the maximum tolerated dose (MTD), with updates anticipated in the second half of 2026, reflecting the company's confidence in clinical development.
- Evaluation of Multiple Tumor Types: Following the dose escalation phase, Phase 1b will expand to include patients with 7 different tumor types, further assessing the safety and preliminary anti-tumor activity of GTB-5550, showcasing its broad application potential.
- Treatment Protocol Design: GTB-5550 will be administered via subcutaneous injection over a 4-week treatment cycle, with disease assessments planned after 2 cycles to track progression-free survival (PFS) and overall survival (OS), providing data support for future treatments.
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About GTBP
GT Biopharma, Inc. is a clinical-stage biopharmaceutical company. The Company is focused on the development and commercialization of immuno-oncology therapeutic products based on its proprietary Tri-specific Killer Engager (TriKE) natural killer (NK) cell engager platform. Its TriKE platform is designed to harness and enhance the cancer-killing abilities of a patient’s immune system’s natural killer cells. Its product candidate pipeline includes GTB-3550, GTB-3650, GTB-5550, GTB-7550, GTB-6550, GTB-1050, and other product candidates. GTB-3550 is a TriKE comprised of two single-chain variable fragments (scFv) composed of the variable regions of the heavy and light chains of anti-CD16 and anti-CD33 antibodies and a modified form of IL-15. GTB-3650 is a TriKE which targets CD33 on the surface of myeloid leukemias. The Company also has a worldwide license agreement with the University of Minnesota to further develop and commercialize therapies using TriKE technology.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
GT Biopharma: Three Drugs Enter Human Trials
- Market Valuation Struggles: As of mid-May 2026, GT Biopharma's market cap stood at approximately $13 million, indicating a significant undervaluation of this clinical-stage immuno-oncology company, prompting investors to consider potential value recovery.
- Significant Clinical Progress: GT Biopharma has advanced three TriKE candidates into clinical trials, with GTB-3650 targeting treatment-resistant blood cancers, and a critical data update expected in the second half of 2026, which could influence the company's future trajectory.
- Innovative Therapeutic Platform: The company holds exclusive rights to the TriKE platform designed to activate natural killer cells to directly attack tumors, leveraging technology from the University of Minnesota, showcasing immense potential in the tumor immunotherapy space that could transform existing treatment paradigms.
- Enormous Market Opportunity: The global oncology market is projected to grow from $139 billion in 2025 to $268 billion by 2034, and if GT Biopharma's product line succeeds, it could secure a significant position in this vast market, leading to substantial commercial returns.
See More
GT Biopharma Advances Three Drug Candidates in Clinical Trials
- Market Valuation: As of May 2026, GT Biopharma's market capitalization stands at approximately $13 million, indicating significant undervaluation by the market despite having three drug candidates in human trials, suggesting a potential investment opportunity.
- Clinical Progress: The lead candidate GTB-3650, targeting treatment-resistant blood cancers, has completed patient enrollment across four dose cohorts, with early safety assessments showing no dose-limiting toxicities, and a meaningful data update is expected in the second half of 2026.
- New Drug Development: The first patient for GTB-5550 was dosed in May 2026, targeting the B7-H3 protein across multiple solid tumors, indicating a market potential significantly larger than that of the blood cancer drug, and it utilizes subcutaneous dosing for improved patient convenience.
- Market Outlook: The global oncology market is projected to grow from approximately $139 billion in 2025 to about $268 billion by 2034, positioning GT Biopharma's technology platform to potentially capture a significant share of this expansive market if successful.
See More
GT Biopharma Advances NK Cell Immunotherapy with TriKE Candidates
- Clinical Advancement: GT Biopharma has advanced three TriKE candidates into the clinic, with GTB-5550 dosing initiated on May 14, 2026, marking a significant milestone in NK cell therapy that is expected to enhance its market competitiveness.
- Innovative Platform: The company's second-generation TriKE platform is described as 10-40 times more potent than the first generation, focusing on activating NK cells through nanobody technology, thereby improving therapeutic efficacy and reducing side effects, further solidifying its position in immuno-oncology.
- Funding Influx: Cumulative funding into NK-focused biotech has exceeded $4.2 billion from 2020 to 2026, indicating strong investment enthusiasm and market potential, with GT Biopharma positioned to benefit from this trend as a key player.
- Market Outlook: North America is expected to capture 44% of the global NK cell therapy market by 2026, and GT Biopharma's clinical trials and financial status provide a solid foundation for growth in this rapidly evolving market.
See More
GT Biopharma Initiates GTB-5550 Clinical Trial for B7-H3 Targeting
- Trial Initiation: On May 14, 2026, GT Biopharma announced the dosing of the first patient in its clinical trial for GTB-5550 targeting B7-H3, marking a significant advancement in the company's oncology pipeline and expected to drive further development.
- Innovative Dosing Method: GTB-5550 is the first TriKE to utilize subcutaneous dosing, which may enhance patient compliance and treatment efficacy compared to traditional continuous infusion therapies, thereby strengthening its competitive position in the market.
- Financial Stability: As of March 31, 2026, GT Biopharma reported a cash balance of approximately $9 million, anticipated to sustain operations through Q4 2026, providing financial assurance during the clinical trial phase and boosting investor confidence.
- Increased Market Competition: The focus on B7-H3 as a tumor target has significantly intensified in 2026, with GTB-5550 standing out as the only NK cell engager currently dosing patients in clinical trials, highlighting its unique market positioning amidst growing competition.
See More
GT Biopharma Doses First Patient in GTB-5550 Clinical Trial
- Trial Launch: On May 14, 2026, GT Biopharma dosed the first patient in its Phase 1 trial for GTB-5550, a B7-H3-targeted natural killer cell engager, marking a significant advancement in cancer treatment, particularly for patients with prostate, ovarian, and pancreatic cancers.
- FDA Approval: The IND application for GTB-5550 received FDA clearance in February 2026, with the trial structured as a basket trial prioritizing enrollment of advanced cancer patients who have failed prior therapies, demonstrating the company's commitment to addressing unmet medical needs.
- Strong Financial Position: As of March 31, 2026, GT Biopharma reported a cash balance of approximately $9 million, anticipated to sustain operations through Q4 2026, thereby enhancing investor confidence in the progress of the clinical trial.
- Significant Market Potential: Targeting the estimated $362 billion global solid tumor market, the B7-H3 antigen has attracted multiple pharmaceutical companies, indicating a rapidly rising clinical translation potential in this competitive landscape.
See More
GT Biopharma Reports Q2 2026 Financial Results
- Widening Net Loss: GT Biopharma reported a net loss of approximately $2.8 million for Q2 2026, a significant increase from the $800,000 loss in the same quarter of 2025, indicating pressure on cost control and market competitiveness.
- Cash Position: As of March 31, 2026, the company had approximately $9 million in cash and cash equivalents, which is anticipated to be sufficient to fund operations through Q4 2026, demonstrating short-term liquidity management capabilities.
- Financial Transparency: The financial information released by GT Biopharma includes historical earnings data and Seeking Alpha’s Quant Rating, aimed at enhancing investor understanding of the company's financial status, although current performance is poor, the company is striving to improve transparency to attract investment.
- Market Outlook Challenges: While the company has a certain level of liquidity assurance, the ongoing losses may undermine investor confidence, necessitating effective measures to improve financial performance to maintain market competitiveness.
See More
GT Biopharma: Three Drugs Enter Human Trials
- Market Valuation Struggles: As of mid-May 2026, GT Biopharma's market cap stood at approximately $13 million, indicating a significant undervaluation of this clinical-stage immuno-oncology company, prompting investors to consider potential value recovery.
- Significant Clinical Progress: GT Biopharma has advanced three TriKE candidates into clinical trials, with GTB-3650 targeting treatment-resistant blood cancers, and a critical data update expected in the second half of 2026, which could influence the company's future trajectory.
- Innovative Therapeutic Platform: The company holds exclusive rights to the TriKE platform designed to activate natural killer cells to directly attack tumors, leveraging technology from the University of Minnesota, showcasing immense potential in the tumor immunotherapy space that could transform existing treatment paradigms.
- Enormous Market Opportunity: The global oncology market is projected to grow from $139 billion in 2025 to $268 billion by 2034, and if GT Biopharma's product line succeeds, it could secure a significant position in this vast market, leading to substantial commercial returns.
See More
GT Biopharma Advances Three Drug Candidates in Clinical Trials
- Market Valuation: As of May 2026, GT Biopharma's market capitalization stands at approximately $13 million, indicating significant undervaluation by the market despite having three drug candidates in human trials, suggesting a potential investment opportunity.
- Clinical Progress: The lead candidate GTB-3650, targeting treatment-resistant blood cancers, has completed patient enrollment across four dose cohorts, with early safety assessments showing no dose-limiting toxicities, and a meaningful data update is expected in the second half of 2026.
- New Drug Development: The first patient for GTB-5550 was dosed in May 2026, targeting the B7-H3 protein across multiple solid tumors, indicating a market potential significantly larger than that of the blood cancer drug, and it utilizes subcutaneous dosing for improved patient convenience.
- Market Outlook: The global oncology market is projected to grow from approximately $139 billion in 2025 to about $268 billion by 2034, positioning GT Biopharma's technology platform to potentially capture a significant share of this expansive market if successful.
See More
GT Biopharma Advances NK Cell Immunotherapy with TriKE Candidates
- Clinical Advancement: GT Biopharma has advanced three TriKE candidates into the clinic, with GTB-5550 dosing initiated on May 14, 2026, marking a significant milestone in NK cell therapy that is expected to enhance its market competitiveness.
- Innovative Platform: The company's second-generation TriKE platform is described as 10-40 times more potent than the first generation, focusing on activating NK cells through nanobody technology, thereby improving therapeutic efficacy and reducing side effects, further solidifying its position in immuno-oncology.
- Funding Influx: Cumulative funding into NK-focused biotech has exceeded $4.2 billion from 2020 to 2026, indicating strong investment enthusiasm and market potential, with GT Biopharma positioned to benefit from this trend as a key player.
- Market Outlook: North America is expected to capture 44% of the global NK cell therapy market by 2026, and GT Biopharma's clinical trials and financial status provide a solid foundation for growth in this rapidly evolving market.
See More
GT Biopharma Initiates GTB-5550 Clinical Trial for B7-H3 Targeting
- Trial Initiation: On May 14, 2026, GT Biopharma announced the dosing of the first patient in its clinical trial for GTB-5550 targeting B7-H3, marking a significant advancement in the company's oncology pipeline and expected to drive further development.
- Innovative Dosing Method: GTB-5550 is the first TriKE to utilize subcutaneous dosing, which may enhance patient compliance and treatment efficacy compared to traditional continuous infusion therapies, thereby strengthening its competitive position in the market.
- Financial Stability: As of March 31, 2026, GT Biopharma reported a cash balance of approximately $9 million, anticipated to sustain operations through Q4 2026, providing financial assurance during the clinical trial phase and boosting investor confidence.
- Increased Market Competition: The focus on B7-H3 as a tumor target has significantly intensified in 2026, with GTB-5550 standing out as the only NK cell engager currently dosing patients in clinical trials, highlighting its unique market positioning amidst growing competition.
See More
GT Biopharma Doses First Patient in GTB-5550 Clinical Trial
- Trial Launch: On May 14, 2026, GT Biopharma dosed the first patient in its Phase 1 trial for GTB-5550, a B7-H3-targeted natural killer cell engager, marking a significant advancement in cancer treatment, particularly for patients with prostate, ovarian, and pancreatic cancers.
- FDA Approval: The IND application for GTB-5550 received FDA clearance in February 2026, with the trial structured as a basket trial prioritizing enrollment of advanced cancer patients who have failed prior therapies, demonstrating the company's commitment to addressing unmet medical needs.
- Strong Financial Position: As of March 31, 2026, GT Biopharma reported a cash balance of approximately $9 million, anticipated to sustain operations through Q4 2026, thereby enhancing investor confidence in the progress of the clinical trial.
- Significant Market Potential: Targeting the estimated $362 billion global solid tumor market, the B7-H3 antigen has attracted multiple pharmaceutical companies, indicating a rapidly rising clinical translation potential in this competitive landscape.
See More
GT Biopharma Reports Q2 2026 Financial Results
- Widening Net Loss: GT Biopharma reported a net loss of approximately $2.8 million for Q2 2026, a significant increase from the $800,000 loss in the same quarter of 2025, indicating pressure on cost control and market competitiveness.
- Cash Position: As of March 31, 2026, the company had approximately $9 million in cash and cash equivalents, which is anticipated to be sufficient to fund operations through Q4 2026, demonstrating short-term liquidity management capabilities.
- Financial Transparency: The financial information released by GT Biopharma includes historical earnings data and Seeking Alpha’s Quant Rating, aimed at enhancing investor understanding of the company's financial status, although current performance is poor, the company is striving to improve transparency to attract investment.
- Market Outlook Challenges: While the company has a certain level of liquidity assurance, the ongoing losses may undermine investor confidence, necessitating effective measures to improve financial performance to maintain market competitiveness.
See More
