Gt Biopharma Inc Stock Price, News & Analysis

GT Biopharma, Inc. (NASDAQ: GTBP) announced the appointment of Gregory Berk, M.D. as Chief Medical Officer, effective April 26, 2021. Dr. Berk, who has over 30 years of oncology development experience, resigns from the Board of Directors to take on this role. Additionally, Jeffrey S. Miller, M.D. transitions from Consulting Chief Medical Officer to Consulting Chief Scientific Officer. The company aims to enhance its TriKE™ protein biologic platform, which targets solid tumors and hematologic cancers. Positive preliminary data for GTB-3550 in AML and MDS have been reported, highlighting a strong safety profile.

GT Biopharma reported its 2020 financial results, highlighting significant progress in its clinical pipeline, particularly with the GTB-3550 TriKE™ program targeting MDS and AML. The company achieved a successful NASDAQ listing and raised $28.7 million during its public offering. Financially, GT Biopharma's cash position increased to $5.3 million, up from $0.3 million in 2019, despite a net loss of $28.3 million for the year. The TriKE™ therapy demonstrates promising efficacy, with interim results showing a 63.7% reduction in cancer cell levels for treated patients.

GT Biopharma, Inc. (NASDAQ: GTBP) announced interim results from its GTB-3550 TriKE™ Phase I/II clinical trial for high-risk myelodysplastic syndromes (MDS) and refractory acute myeloid leukemia (AML). The GTB-3550 TriKE™ monotherapy has shown promising results, demonstrating up to a 63.7% reduction in bone marrow blast levels and restoring NK cell function in patients. Notably, the treatment is well tolerated, requiring no pre-treatment regimens. The therapy’s cost-effectiveness and ability to be used without supplemental cell therapies highlight its competitive edge in the market.

GT Biopharma, Inc. (NASDAQ: GTBP) announced the enrollment of Patient 10 in its GTB-3550 TriKE™ Phase I/II clinical trial targeting high-risk myelodysplastic syndromes (MDS) and relapsed acute myeloid leukemia (AML). Dosing for Patient 10 is set at 100mcg/kg/day. Earlier trial results showed a significant 63.7% reduction in bone marrow blast levels and improvements in NK cell function without severe side effects. Currently, the trial aims to establish the maximum tolerated dose and assess NK and T cell functionality.

GT Biopharma announced updated interim Phase I/II clinical trial results for GTB-3550 TriKE™, aimed at treating high-risk myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML), during the Innate Killer Summit 2021. Key findings include a 63.7% reduction in bone marrow blasts, with a significant number of patients responding positively. Importantly, no cytokine release syndrome (CRS) was observed, and the treatment does not rely on progenitor-derived therapies. The trial involved 9 patients, and ongoing dose escalation aims to enhance efficacy.

GT Biopharma, Inc. (NASDAQ: GTBP) announced updated interim results from its Phase I/II clinical trial of GTB-3550, aimed at treating high-risk myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML). The trial involved 9 patients, of whom 60% showed reduced bone marrow blasts, with significant reductions in two patients. Notably, no cases of Cytokine Release Syndrome (CRS) were reported. CEO Anthony Cataldo expressed optimism about the ongoing dose escalation and the potential for GTB-3550 to offer a less expensive alternative to existing therapies. The company’s focus remains on advancing its innovative TriKE technology.

GT Biopharma (NASDAQ: GTBP) will present at the Virtual 33rd Annual Roth Conference on March 17, 2021, at 12:00 p.m. ET. The presentation will cover its innovative Natural Killer (NK) cell engager immunotherapy platform, TriKE™, designed for treating cancers and infectious diseases. The GTB-3550 TriKE™ is in a Phase I/II clinical trial for patients with CD33+ malignancies, showing promising interim results in reducing bone marrow blast levels in AML and MDS patients. A live webcast can be accessed on the company's website.

GT Biopharma, Inc. (NASDAQ: GTBP) has announced promising preclinical results for its ROR1 TriKE™ product candidate aimed at treating prostate cancer. ROR1, a receptor overexpressed in various cancers, was targeted using TriKE™ technology to enhance Natural Killer (NK) cell activity. Results showed effective NK cell killing in multiple prostate cancer cell lines, as well as significant NK cell activation and interferon gamma production. The company plans further IND-enabling studies, with the aim to transition to a Phase I/II clinical trial.

GT Biopharma (NASDAQ: GTBP) announced the addition of the University of Wisconsin – Madison Carbone Cancer Center as a second site for its ongoing Phase I/II clinical trial of GTB-3550 TriKE™. This trial targets patients with CD33+ malignancies, including acute myeloid leukemia (AML). The trial aims to evaluate the safety and maximum tolerated dose of GTB-3550 TriKE™. Interim results showed reduction in bone marrow blast levels in AML patients with no reported toxicities. The trial is part of GT Biopharma's effort to advance its NK cell engager immunotherapy platform.