EXCLUSIVE: GT Biopharma Advances Relapsed Blood Cancer Therapy Trial To Cohort 2 After Promising Early Safety Results

GT Biopharma, Inc. GTBP announced Monday that it has successfully completed dosing in Cohort 1 and started dosing in Cohort 2 of its Phase 1 dose escalation trial for GTB-3650. The therapy is a second-generation TriKE therapeutic targeting relapsed or refractory CD33-expressing hematologic malignancies.

GT Biopharma specializes in immuno-oncology therapies using its proprietary TriKE NK cell engager platform and holds an exclusive global license with the University of Minnesota for its development and commercialization.

No safety or tolerability issues were observed in Cohort 1, allowing progression to the next cohort, the company said.

Early biomarker analysis from Cohort 1 patients indicates increased immunologic activity, suggesting activation and expansion of natural killer (NK) cells.

The trial, which may include up to 14 patients across seven cohorts, involves two-week dosing blocks over a four-month period and will evaluate safety, pharmacokinetics, pharmacodynamics, NK cell expansion, and clinical activity.

The company said that it will release detailed results in 2025.

In January, the company had initiated patient dosing with GTB-3650 in the Phase 1 trial to evaluate the potential in patients with hematological malignancies.

Price Action: GTBP stock traded higher by 0.90% to $2.26 premarket at the last check on Monday.

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