GT Biopharma advances Phase 1 trial of NK cell therapy with no safety issues

SAN FRANCISCO - GT Biopharma, Inc. (NASDAQ:GTBP), a micro-cap biotech company with a market capitalization of $2.67 million, reported Wednesday that both patients in Cohort 3 of its Phase 1 trial evaluating GTB-3650 have begun treatment with no dose-limiting toxicities or safety concerns observed to date. According to InvestingPro analysis, the stock appears undervalued based on its Fair Value assessment.

The clinical trial is assessing GTB-3650, a TriKE natural killer cell engager therapy, for the treatment of relapsed or refractory CD33 expressing hematologic malignancies. The company, which has seen its stock surge 15.65% over the past week, noted that the first patient in Cohort 3 has demonstrated immune activation consistent with levels seen in patients from the two previous lower-dose cohorts.

Following successful completion of the Cohort 3 safety assessment, GT Biopharma plans to continue dose escalation with Cohort 4 by year-end 2025. The Phase 1 protocol allows for evaluation in up to seven cohorts with doses ranging from 1.25μg/kg/day in Cohort 1 to 100μg/kg/day in Cohort 7.

According to the company, GTB-3650 is administered in two-week blocks—two weeks on and two weeks off—for up to four months based on clinical benefit. The trial is designed to assess safety, pharmacokinetics, pharmacodynamics, in vivo expansion of endogenous patient NK cells, and clinical activity.

GT Biopharma anticipates providing additional data updates in the first quarter of 2026. With the company’s next earnings report due on November 13, 2025, InvestingPro subscribers can access 10+ additional investment tips and comprehensive financial metrics to better evaluate the company’s progress.

The company’s TriKE platform is designed to enhance the cancer-killing abilities of a patient’s natural killer cells. GT Biopharma, maintaining a healthy current ratio of 3.09, holds an exclusive worldwide license agreement with the University of Minnesota to develop and commercialize therapies using this technology.

This information is based on a company press release statement.

In other recent news, GT Biopharma, Inc. reported that holders of its Series L 10% Convertible Preferred Stock have waived their redemption rights. This decision was formalized through a waiver to the Certificate of Designation of Preferences, Rights and Limitations for the Series L stock, as stated in a press release and a filing with the Securities and Exchange Commission. Additionally, GT Biopharma has started dosing in the third cohort of its Phase 1 trial for GTB-3650, which targets relapsed or refractory CD33 expressing hematologic malignancies. The trial has progressed without any safety or tolerability issues in the first two cohorts, and the first patient in Cohort 3 has completed the initial week of cycle 1. These developments are part of the company’s ongoing efforts in advancing its clinical trials.

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