Moleculin Biotech Partners With Spain’s CIC biomaGUNE To Launch New Preclinical Studies Of Annamycin For Deadly Glioblastoma

Moleculin Biotech, Inc., a late-stage pharmaceutical company developing drug candidates for difficult-to-treat cancers and viral infections, has announced a new research and material transfer agreement with CIC biomaGUNE. CIC biomaGUNE is a leading non-profit research institute in the Basque Country, Spain, dedicated to advancing scientific innovation. Through this collaboration, the organization will conduct investigator-initiated preclinical studies to evaluate Moleculin’s drug candidate Annamycin for the treatment of glioblastoma multiforme (GBM), one of the most aggressive and deadly forms of brain cancer.

According to the agreement, Moleculin will provide Annamycin, while Jesús Ruiz-Cabello, Principal Investigator at CIC biomaGUNE, will lead the planned research. The studies aim to assess tumor progression following intra-arterial delivery of liposomal Annamycin (L-Annamycin) and Free-Annamycin in comparison with Doxil and Free-doxorubicin in mouse models. This research is designed to further explore Annamycin’s potential effectiveness and ability to address drug-delivery challenges associated with brain tumors.

Walter Klemp, Chairman and CEO of Moleculin, emphasized that this collaboration expands the company’s growing portfolio of investigator-initiated studies involving Annamycin. He noted that Annamycin has already shown clinical activity in acute myeloid leukemia (AML) and soft tissue sarcomas, while also demonstrating encouraging results in preclinical models of pancreatic cancer, GBM, and certain types of liver cancer.

Klemp added that GBM remains an area where treatment options are extremely limited, with existing therapies offering only modest survival benefits and no durable solutions. He said that partnering with CIC biomaGUNE’s highly regarded research team will help advance the understanding of Annamycin’s potential in overcoming drug-resistance and delivery barriers typical in central nervous system tumors. According to him, this work not only underscores the broad therapeutic possibilities of Annamycin but also reinforces Moleculin’s commitment to developing innovative treatments for cancers with few or no effective options.

Glioblastoma is the most common and aggressive malignant primary brain tumor. In the United States, it has an average annual incidence rate of 3.19 cases per 100,000 people. It accounts for 54% of all gliomas and 16% of all primary brain tumors. Despite progress in other oncology fields, median survival for GBM remains only about 15 months, and outcomes have not significantly improved over the past three decades.

Annamycin, also known as naxtarubicin, holds Fast Track Status and Orphan Drug Designation from the U.S. Food and Drug Administration for the treatment of relapsed or refractory AML, as well as Orphan Drug Designation for treating soft tissue sarcoma lung metastases. The European Medicines Agency has also granted Orphan Drug Designation for Annamycin in relapsed or refractory AML, further supporting its development as a promising therapy for patients with limited treatment choices.