Moleculin Partners with CIC biomaGUNE to Evaluate Annamycin for Glioblastoma Treatment
Key Insights
Moleculin Biotech has entered a research agreement with CIC biomaGUNE (search) to conduct preclinical studies evaluating Annamycin for glioblastoma multiforme (search) treatment.
The studies will compare intra-arterial delivery of liposomal and free Annamycin against Doxil and doxorubicin in mouse models.
Glioblastoma (search) remains a devastating brain cancer (search) with median survival of only 15 months and no significant survival improvements in three decades.
Moleculin Biotech has announced a new research collaboration with CIC biomaGUNE (search), a Spanish non-profit research organization, to evaluate its lead drug candidate Annamycin for the treatment of glioblastoma multiforme (search) (GBM), one of the most aggressive forms of brain cancer (search). The investigator-initiated preclinical studies will specifically examine the effects of intra-arterial delivery of the drug in combating this devastating malignancy.
Under the research and material transfer agreement, Moleculin will supply Annamycin while Jesús Ruiz-Cabello, Principal Investigator at CIC biomaGUNE (search), will conduct the planned preclinical research. The studies will evaluate tumor progression following intra-arterial delivery of both liposomal Annamycin (L-Annamycin) and Free-Annamycin compared to Doxil and Free-doxorubicin in mouse models.
Addressing Critical Unmet Medical Need
Glioblastoma (search) represents one of the most challenging cancers to treat, with statistics highlighting the urgent need for new therapeutic approaches. The average annual age-adjusted incidence rate of glioblastoma is 3.19 per 100,000 persons in the United States. As the most aggressive malignant primary brain tumor, glioblastoma carries a median survival of only 15 months and represents the most common malignant primary brain tumor, making up 54% of all gliomas and 16% of all primary brain tumors.
Perhaps most concerning is that despite advancements for other cancers, the survival rate for glioblastoma (search) has not changed significantly in the last three decades, underscoring the critical need for innovative treatment approaches.
Walter Klemp, Chairman and CEO of Moleculin, emphasized the significance of this collaboration: "GBM remains an area of profound unmet medical need, with current therapies offering only limited survival benefit and no meaningful long-term solutions. Collaborating with the premier research team at CIC biomaGUNE (search) provides an important opportunity to explore Annamycin's potential to overcome the challenges of drug delivery and resistance in central nervous system tumors."
Annamycin's Expanding Clinical Portfolio
Annamycin, also known by its non-proprietary name naxtarubicin, is a next-generation anthracycline designed to avoid multidrug resistance mechanisms and to lack the cardiotoxicity common with currently prescribed anthracyclines. The drug has already demonstrated clinical activity in acute myeloid leukemia (search) and soft tissue sarcomas (search) while showing potential in preclinical models in pancreatic, GBM, and certain liver cancers (search).
The drug candidate currently holds Fast Track Status and Orphan Drug Designation from the FDA for the treatment of relapsed or refractory AML, in addition to Orphan Drug Designation for the treatment of STS lung metastases. Furthermore, Annamycin has received Orphan Drug Designation for the treatment of relapsed or refractory AML from the European Medicines Agency (EMA).
Moleculin has already begun the MIRACLE (Moleculin R/R AML AnnAraC Clinical Evaluation) Trial (MB-108), a pivotal, adaptive design Phase 3 trial evaluating Annamycin in combination with cytarabine, together referred to as AnnAraC, for the treatment of relapsed or refractory acute myeloid leukemia (search). Following a successful Phase 1B/2 study (MB-106), with input from the FDA, the company believes it has substantially de-risked the development pathway towards a potential approval for Annamycin for the treatment of AML.
Strategic Research Expansion
Klemp noted the strategic importance of expanding Annamycin's research footprint: "We are excited to further expand our efforts to advance and develop Annamycin across a number of investigator-initiated studies. This work highlights the potential breadth of Annamycin and underscores our commitment to advancing innovative therapies for patients facing cancers with few or no effective options."
The collaboration with CIC biomaGUNE (search) represents part of Moleculin's broader strategy to explore Annamycin's therapeutic potential across multiple cancer indications. Beyond its current development in AML and soft tissue sarcomas (search), the company is investigating the drug's potential in various solid tumors where traditional anthracyclines have shown limited efficacy due to resistance mechanisms or toxicity concerns.
This preclinical research initiative could provide crucial data on Annamycin's ability to penetrate the blood-brain barrier and effectively target glioblastoma (search) cells, potentially opening a new therapeutic avenue for patients facing this devastating diagnosis.