Welcome to our dedicated page for Gt Biopharma news (Ticker: GTBP), a resource for investors and traders seeking the latest updates and insights on Gt Biopharma stock.
GT Biopharma Inc. (NASDAQ: GTBP) is a clinical-stage immuno-oncology company developing cancer therapeutics based on its proprietary TriKE natural killer (NK) cell engager platform. The GTBP news feed on Stock Titan aggregates company press releases, clinical updates, financial disclosures, and other public announcements so readers can follow how its NK cell–based programs progress over time.
News about GT Biopharma frequently centers on its lead clinical candidate GTB-3650, a second-generation TriKE being evaluated in a Phase 1 dose-escalation trial for relapsed or refractory CD33-expressing hematologic malignancies, including acute myeloid leukemia and high-risk myelodysplastic syndrome. Regular updates describe enrollment status across multiple cohorts, results of formal safety reviews, early observations on immune activation and NK cell expansion, and plans for subsequent dose levels within the study protocol.
Another recurring theme in GTBP news is the advancement of GTB-5550, a camelid nanobody-based TriKE targeting B7-H3–expressing solid tumors. Company announcements cover key regulatory milestones such as submission of an investigational new drug (IND) application to the U.S. Food and Drug Administration and outline the design of a planned Phase 1 basket trial using subcutaneous dosing across several metastatic solid tumor cohorts.
Investors and observers will also find financial result releases, which summarize cash position, research and development spending related to GTB-3650 and GTB-5550, and general operating expenses, along with 8-K-linked updates on Nasdaq listing matters and capital structure changes. Conference participation notices and board or governance updates provide additional context on how GT Biopharma presents its NK cell engager strategy to the investment community.
By reviewing GTBP news on this page, readers can track clinical milestones, regulatory interactions, financing developments, and corporate actions that shape the company’s progress in NK cell–based immuno-oncology.
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.
GT Biopharma has appointed Michael Handelman, CPA, as its new Chief Financial Officer. Mr. Handelman has an extensive background, previously serving as CFO for Iovance Biotherapeutics and Clickstream Corporation. His expertise in financial management within the biotech sector is expected to enhance GT Biopharma's operational and clinical development of its NK cell engager technology, TriKE™. The company focuses on innovative cancer therapies, particularly its GTB-3550 candidate aimed at treating acute myeloid leukemia (AML) and related conditions.
GT Biopharma has announced that its abstract, titled "GTB-3550 TriKE™ for the Treatment of High-Risk Myelodysplastic Syndromes (MDS) and Refractory/Relapsed Acute Myeloid Leukemia (AML) Safely Drives Natural Killer (NK) Cell Proliferation At Initial Dose Cohorts", has been selected for oral presentation at the 62nd ASH Annual Meeting on December 5, 2020. Interim data from 7 enrolled patients showed promising NK cell activity without serious adverse events. The drug aims to offer therapy for patients lacking actionable mutations, with plans for further clinical evaluation to demonstrate potential efficacy.