GT Biopharma Advances into Cohort 3 of GTB-3650 Phase 1 Trial Following Safety Review of Cohort 2
Rhea-AI Summary
GT Biopharma (NASDAQ: GTBP) has advanced to Cohort 3 in its Phase 1 clinical trial of GTB-3650, following successful safety reviews of Cohorts 1 and 2. GTB-3650, a second-generation TriKE® natural killer cell engager, is being evaluated for treating relapsed/refractory CD33-expressing hematologic malignancies.
The trial's first four patients have shown encouraging early results, demonstrating GTB-3650's ability to activate and expand NK cells, with multiple blood biomarker assays indicating heightened immune activity. The study plans to enroll up to 14 patients across seven cohorts, with dosing in two-week cycles for up to four months. Initial Phase 1 results are expected later in 2025.
Positive
- No safety or tolerability issues observed in Cohorts 1 and 2
- Early results show successful NK cell activation and expansion
- Blood biomarker assays indicate heightened immune activity
- Trial progressing as planned with advancement to Cohort 3
Negative
- None.
News Market Reaction – GTBP
On the day this news was published, GTBP declined 2.79%, reflecting a moderate negative market reaction. This price movement removed approximately $168K from the company's valuation, bringing the market cap to $6M at that time.
Data tracked by StockTitan Argus on the day of publication.
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
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