GT Biopharma (NASDAQ:GTBP) Enters Investigator Initiated Clinical Trial Agreement with the University of Minnesota

On November 18, 2024, GT Biopharma, Inc. entered into an Investigator Initiated Clinical Trial Agreement with the Regents of the University of Minnesota. This agreement entails the University sponsoring an Investigational New Drug application for IND 165546 GTB-3650, a Research Program, and serving as a sponsor investigator for a phase 1 clinical trial titled, “GTB-3650 (CD16/IL-15/CD33) Tri-Specific Killer Engager (TriKE) for the Treatment of High Risk Myelodysplastic Syndromes (MDS), Refractory/Relapsed Acute Myeloid Leukemia (AML), and Minimal Residual Disease in AML.”

The Research Program, intended for clinical research use, will have a budget of up to approximately $2 million over three years, funded by GT Biopharma. While University will own the Study data, GT Biopharma can utilize the data subject to compliance with informed consent documents, authorization forms, applicable laws, and terms of the Agreement. Both parties will have the right to publish the Study results.

The Agreement allows for termination by either party with a thirty days’ written notice, immediate termination by the University for health, welfare, and safety reasons, or termination by either party in case of material breach, provided the breaching party does not rectify the breach within thirty days.

The description of the Agreement provided is not exhaustive, and for full details, readers are directed to the complete text of the Agreement attached to the Current Report on Form 8-K as Exhibit 10.1.

In accordance with Item 9.01 of the filing, the company has also disclosed that relevant financial statements and Exhibits are available for reference, with Exhibit 10.1 being the Investigator Initiated Clinical Trial Agreement between GT Biopharma, Inc. and the Regents of the University of Minnesota.

The signing of the report on behalf of GT Biopharma, Inc. was done by Alan Urban, the Chief Financial Officer, as per the requirements of the Securities Exchange Act of 1934.

This press release conveys actual information from the 8-K filed with the SEC and does not contain any fabricated details or speculative content.

This article was generated by an automated content engine and was reviewed by a human editor prior to publication. For additional information, read GT Biopharma’s 8K filing here.

GT Biopharma Company Profile

GT Biopharma, Inc, a clinical stage biopharmaceutical company, focuses on the development and commercialization of immuno-oncology products based on its proprietary Tri-specific Killer Engager (TriKE) fusion protein immune cell engager technology platform. It develops GTB-3550, a single-chain tri-specific recombinant fusion protein conjugate that is in Phase I clinical trial for the treatment of myelodysplastic syndromes, refractory/relapsed acute myeloid leukemia or advanced systemic mastocytosis, and CD33+ malignancies.