GT Biopharma Advances into Cohort 3 of GTB-3650 Phase 1 Trial Following Safety Review of Cohort 2
MWN-AI** Summary
GT Biopharma, Inc. (NASDAQ: GTBP) has announced the initiation of Cohort 3 in its Phase 1 dose escalation trial for GTB-3650, aimed at treating relapsed or refractory CD33-expressing hematologic malignancies. The advancement follows a successful safety review of Cohort 2, where no safety or tolerability issues were reported. The first patient in Cohort 3, also the trial's fifth patient, has completed the initial week of treatment.
The ongoing Phase 1 trial investigates GTB-3650, the second-generation therapeutic derived from GT Biopharma's proprietary TriKE® (T-cell Redirection through NK cell Engagement) platform. Both Cohort 1 and Cohort 2 have demonstrated promising early results, suggesting that GTB-3650 effectively activates endogenous natural killer (NK) cells and promotes their expansion. Biomarker data from these cohorts reveal enhanced immune activity, encouraging researchers and stakeholders about the ongoing treatment's potential.
In total, the trial targets approximately 14 patients across seven cohorts, with doses administered in two-week blocks over a period of up to four months, contingent on clinical benefit. The study will evaluate various parameters including safety, pharmacokinetics, pharmacodynamics, NK cell expansion, and overall clinical activity of GTB-3650.
GT Biopharma plans to release initial results from the Phase 1 study by late 2025, following the completion of additional dosing cohorts. This timeline reflects the pharmaceutical company's commitment to advancing its immuno-oncology pipeline, which leverages ground-breaking technologies aimed at harnessing the body's immune response to combat cancer. As GT Biopharma moves forward with its trials, the scientific community and investors alike will be closely monitoring developments in this promising therapeutic landscape.
MWN-AI** Analysis
GT Biopharma, Inc. (NASDAQ: GTBP) is making significant progress in its clinical trials, particularly with the GTB-3650 Phase 1 study focused on relapsed or refractory CD33 expressing hematologic malignancies. Following a successful safety review of Cohort 2, the company has advanced to Cohort 3, a move that signals confidence in the safety and potentially the efficacy of its proprietary TriKE® platform.
As the first patient in Cohort 3 completes Cycle 1, market watchers should note that the initial results from earlier cohorts have shown promising immune responses. The activation and expansion of natural killer (NK) cells in patients could indicate a future therapeutic potential for GTB-3650, which is particularly relevant given the growing interest in immuno-oncology treatments.
Investors should pay attention to the forthcoming data release later in 2025 as it will provide crucial insights into the drug's clinical activity and pharmacodynamic effects. The trial's design, which includes evaluations of safety and immune response through multiple assays, further supports the potential for robust clinical outcomes. If the results continue to reflect the initial encouraging signals, it may lead to heightened interest and valuation for GT Biopharma.
However, it is essential to remain cognizant of the inherent risks in biopharmaceutical development, including the possibility of adverse results in later-stage cohorts or regulatory challenges. Interested investors might consider a balanced portfolio approach, participating in GTBP with a focus on the long-term viability of its products while being prepared for volatilities that accompany clinical trials.
In conclusion, GT Biopharma's advancements in the GTB-3650 trial represent a bright spot in its pipeline. While the initial safety profile is solid, ongoing monitoring of trial results and market developments is advised for informed decision-making.
**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.
The first patient in Cohort 3, the fifth patient in the trial, has completed the first week of cycle 1 following the successful safety review of Cohort 2 with no safety or tolerability issues observed
The company plans on releasing initial Phase 1 results later in 2025 following completion of additional dose cohorts
SAN FRANCISCO, CALIFORNIA, Aug. 11, 2025 (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 initiation of dosing in Cohort 3 of its Phase 1 dose escalation trial evaluating GTB-3650 for the treatment of relapsed or refractory (r/r) CD33 expressing hematologic malignancies.
The Phase 1 dose escalation trial is evaluating GTB-3650, GT Biopharma’s second-generation TriKE, for the treatment of relapsed or refractory (r/r) CD33 expressing hematologic malignancies. Cohorts 1 and 2 have now both been successfully completed and following the formal safety reviews, no safety or tolerability issues have been observed. This has allowed initiation of dosing in Cohort 3, with the first patient now having completed the first week of cycle 1.
Patients from Cohort 1 and Cohort 2 have shown encouraging early results indicative of GTB-3650’s ability to activate endogenous NK cells and induce NK cell expansion. Data from multiple blood biomarker assays from the first four patients show heightened immune activity. GT Biopharma plans on releasing initial Phase 1 results later in 2025 following completion of additional dose cohorts.
The trial plans to evaluate GTB-3650 in up to approximately 14 patients (seven cohorts) and GTB-3650 will be dosed in two-week blocks, two weeks on and two weeks off (defining a treatment cycle), for up to four months based on clinical benefit. The trial will assess safety, pharmacokinetics, pharmacodynamics, in vivo expansion of endogenous patient NK cells and clinical activity. More details can be found on clinicaltrials.gov with the identifier: NCT06594445 .
About GT Biopharma, Inc.
GT Biopharma, Inc. is a clinical stage biopharmaceutical company focused on the development and commercialization of immuno-oncology therapeutic products based on our proprietary TriKE ® NK cell engager platform. Our TriKE ® platform is designed to harness and enhance the cancer killing abilities of a patient’s immune system’s natural killer cells. GT Biopharma has an exclusive worldwide license agreement with the University of Minnesota to further develop and commercialize therapies using TriKE ® technology. For more information, please visit gtbiopharma.com .
Forward-Looking Statements
Certain statements in this press release may constitute "forward-looking statements" regarding future events and our future results. All statements other than statements of historical facts are statements that could be deemed to be forward-looking statements. These statements are based on current expectations, estimates, forecasts, and projections about the markets in which we operate and the beliefs and assumptions of our management. Words such as "expects," "anticipates," "targets," "goals," "projects", "intends," "plans," "believes," "seeks," "estimates," "endeavors," "strives," "may," or variations of such words, and similar expressions are intended to identify such forward-looking statements. Readers are cautioned that these forward-looking statements are subject to a number of risks, uncertainties and assumptions that are difficult to predict, estimate or verify. Therefore, actual results may differ materially and adversely from those expressed in any forward-looking statements. Such risks and uncertainties include those factors described in our most recent annual report on Form 10-K, as such may be amended or supplemented by subsequent quarterly reports on Form 10-Q, or other reports filed with the Securities and Exchange Commission. Readers are cautioned not to place undue reliance on these forward-looking statements. The forward-looking statements are made only as of the date hereof, and we undertake no obligation to publicly release the result of any revisions to these forward-looking statements. For more information, please refer to our filings with the Securities and Exchange Commission.
TriKE ® is a registered trademark owned by GT Biopharma, Inc.
Investor Relations Contact:
LifeSci Advisors
Corey Davis, Ph.D.
cdavis@lifesciadvisors.com
212-915-2577
FAQ**
What specific improvements in immune activity have been observed in patients from Cohorts 1 and 2 in the GT Biopharma Inc. GTBP trial, and how do these results inform expectations for Cohort 3's outcomes?
Given the successful safety reviews of Cohorts 1 and what are the anticipated challenges or risks as GT Biopharma Inc. GTBP moves forward with additional dose cohorts in the Phase 1 trial?
How does the dosing schedule of GTB-3650 impact the pharmacokinetics and pharmacodynamics being evaluated in the ongoing Phase 1 trial by GT Biopharma Inc. GTBP, and what insights are expected from the two-week on/off cycle?
What key metrics will GT Biopharma Inc. GTBP prioritize when releasing initial Phase 1 results later in 2025, and how will these metrics shape future development of the TriKE platform?
**MWN-AI FAQ is based on asking OpenAI questions about GT Biopharma Inc. (NASDAQ: GTBP).
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