GT Biopharma Inc. - GTBP STOCK NEWS

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.

GT Biopharma, Inc. (NASDAQ: GTBP) announced an expanded GMP manufacturing agreement with Cytovance Biologics to enhance manufacturing of TriKE™ immunotherapy products. This transition positions the company for large-scale production in anticipation of further clinical trials for GTB-3550 TriKE™, targeting Acute Myeloid Leukemia (AML) and Myelodysplastic syndromes (MDS). Interim results indicate GTB-3550 TriKE™ effectively reduces bone marrow blast levels in patients without toxicities. The company aims to initiate additional clinical trials in early 2022, boosting its potential market presence.

GT Biopharma, Inc. (NASDAQ: GTBP) has successfully closed an underwritten public offering of 4,300,000 Units at $5.50 per Unit, raising approximately $23.6M in gross proceeds. The offering includes a 45-day over-allotment option for underwriters to purchase an additional 645,000 Units. Following the offering, GT Biopharma's cash position is about $30M, extending its runway through 2022, and successfully extinguishing over $25M in debt. This financing supports ongoing clinical trials for its TriKE™ platform targeting cancer therapies, particularly for Acute Myeloid Leukemia and Myelodysplastic syndromes.

GT Biopharma announced an underwritten public offering of 4,300,000 Units at $5.50 each, expected to close on February 16, 2021. The offering aims to raise approximately $23.6 million before expenses. An over-allotment option allows underwriters to purchase an additional 645,000 Units. Following a 1-for-17 reverse stock split, GT Biopharma's common stock will begin trading on The Nasdaq Capital Market under the ticker symbol GTBP on February 11, 2021. The offering is facilitated by Roth Capital Partners and Dawson James Securities.

GT Biopharma has appointed Dr. Greg Berk, M.D. to its Board of Directors. Dr. Berk brings extensive experience in oncology drug development, having previously held senior positions at Verastem, Sideris Pharmaceuticals, and BIND Therapeutics. He is expected to contribute significantly to the advancement of the company's proprietary NK cell engager (TriKE™) technology, particularly in developing its lead candidate, GTB-3550, for treating acute myeloid leukemia (AML). GT Biopharma aims to harness the immune system to combat cancer effectively.