Business
GT Biopharma Reports Second Quarter 2024 Financial Results and Provides Corporate Update
GTB-3650 TriKE® Phase 1 trial initiation expected in 2H 2024; initial clinical data expected in 1H 2025GTB-5550 TriKE® IND submission for treatment of B7H3
About this update from Gt Biopharma, Inc.
[{"type":"text","content":"GTB-3650 TriKE® Phase 1 trial initiation expected in 2H 2024; initial clinical data expected in 1H 2025GTB-5550 TriKE® IND submission for treatment of B7H3 positive solid tumors expected in 1H 2025GTB-5550 Phase 1 dose escalation basket trial initiation expected in 2025 evaluating six solid tumor types, including prostate, breast, head and neck, ovarian, lung, and GIGTB-7550 TriKE® is in preclinical development for autoimmune indications and targets CD19Cash of approximately $9.2 million as of June 30, 2024, anticipated to be sufficient to fund operations into 2025 SAN FRANCISCO, CALIFORNIA, Aug. 14, 2024 (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 natural killer (NK) cell engager, TriKE® platform, today announced second quarter 2024 financial results for the period ended June 30, 2024. “We are thrilled to be in a position to initiate a Phase 1 trial evaluating GTB-3650 in cancer patients in the second half of this year. Initial data from the dose escalation phase of this trial is anticipated in the first half of 2025. We also expect to submit a second IND, for GTB-5550, in the first half of 2025, which has much broader potential in multiple solid tumors and could fuel our future success as a company specializing in NK cell engagers”, said Michael Breen, Executive Chairman and interim Chief Executive Office of GT Biopharma. The Phase 1 dose escalation study will evaluate GTB-3650 in up to six cohorts (two patients per cohort) in adults with relapsed or refractory (r/r) CD33 expressing hematologic malignancies, including refractory acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS). GTB-3650 will be dosed in two-week blocks, two weeks on and two weeks off, 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. “We also remain active in exploring additional opportunities where our TriKE platform technology may have therapeutic utility, especially for autoimmune indications, which are quickly becoming recognized as an intriguing new area for immune-related therapies. Another area of continued interest and work is thoroughly assessing...