FDA Clears IND Application for GTB-3650, an NK Cell Engager for CD33+ Leukemia Treatment

SAN FRANCISCO, CALIFORNIA, June 27, 2024 — GT Biopharma, Inc., a clinical-stage immuno-oncology company specializing in innovative therapies using its proprietary TriKE® (Tri-specific Killer Engager) platform, has announced that the FDA has cleared its Investigational New Drug (IND) application for GTB-3650. This clearance enables the company to initiate a Phase 1 clinical trial, expected to commence in the latter half of 2024.

Michael Breen, the Executive Chairman and Interim CEO of GT Biopharma, expressed his enthusiasm about this milestone. He highlighted the company's plan to submit another IND application for GTB-5550 in the first quarter of 2025, targeting a range of solid tumors. Breen emphasized the company’s commitment to advancing their clinical activities, noting the anticipated commencement of the GTB-3650 Phase 1 trial in the coming months. The company expects to have multiple data readouts by 2025 and is particularly optimistic about launching a basket trial for GTB-5550 targeting various solid tumors within the same year.

The upcoming Phase 1 dose escalation study will focus on evaluating GTB-3650 in adult patients with relapsed or refractory CD33 expressing hematologic malignancies, including acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS). The dosing regimen will consist of two-week blocks, alternating between two weeks on and two weeks off, extending up to four months depending on clinical benefit. Key aspects of the trial include assessments of safety, pharmacokinetics, pharmacodynamics, in vivo expansion of the patients' endogenous natural killer (NK) cells, and overall clinical activity.

Breen elaborated on the potential of GTB-3650 to target NK cells within the immune system, potentially overcoming the limitations associated with current AML chemotherapies. He underscored that the trial design is expected to provide early indicators of safety and therapeutic efficacy, which will be invaluable in shaping future clinical development plans for other TriKE molecules, including GTB-5550.

GT Biopharma’s proprietary TriKE® technology is at the core of its therapeutic approach. TriKE constructs are composed of three key components: one arm engages with CD16, an activating receptor of NK cells; an interleukin (IL)-15 moiety, which is crucial for NK cell survival, proliferation, priming, and motility; and another arm that targets tumor-specific antigens. The company holds an exclusive worldwide license agreement with the University of Minnesota to further develop and commercialize therapies based on TriKE® technology.

The company is also planning to initiate a Phase 1 dose escalation basket trial for GTB-5550 in 2025, which aims to evaluate its efficacy across six types of solid tumors: prostate, breast, head and neck, ovarian, lung, and gastrointestinal cancers. The submission of the IND for GTB-5550 is anticipated in the first quarter of 2025.

GT Biopharma anticipates that its current cash resources will be sufficient to fund its operations into 2025, supporting the progress of these crucial clinical trials.

In summary, GT Biopharma’s advancements in the field of immuno-oncology, particularly through the development of its TriKE® platform, are poised to offer new therapeutic options for patients with various hematologic malignancies and solid tumors. With the FDA clearance of its GTB-3650 IND and the upcoming trials for GTB-5550, the company is on a promising path toward significant clinical developments.

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