Moleculin Announces New Annamycin Collaboration in Brain Tumors

Core Viewpoint - Moleculin Biotech, Inc. has entered into a research agreement with CIC biomaGUNE to evaluate Annamycin for treating glioblastoma multiforme, a challenging brain cancer with significant unmet medical needs [2][4]. Company Overview - Moleculin Biotech, Inc. is a late-stage pharmaceutical company focused on developing drug candidates for hard-to-treat cancers and viral infections [2][6]. - The company's lead program, Annamycin, is a next-generation anthracycline designed to avoid multidrug resistance and cardiotoxicity associated with existing treatments [6]. Research Agreement Details - Under the agreement, Moleculin will supply Annamycin, and CIC biomaGUNE will conduct preclinical studies comparing the effects of intra-arterial delivery of liposomal Annamycin and Free-Annamycin against Doxil and Free-doxorubicin in mouse models [3][4]. - The research aims to explore Annamycin's potential to address drug delivery challenges and resistance in central nervous system tumors [4]. Glioblastoma Multiforme Insights - Glioblastoma is the most aggressive primary brain tumor, accounting for 54% of all gliomas and 16% of all primary brain tumors, with a median survival of only 15 months [4]. - The average annual age-adjusted incidence rate of glioblastoma in the U.S. is 3.19 per 100,000 persons, and survival rates have not significantly improved in the last three decades [4]. Annamycin's Regulatory Status - Annamycin has received Fast Track Status and Orphan Drug Designation from the FDA for treating relapsed or refractory acute myeloid leukemia (AML) and soft tissue sarcoma lung metastases [5]. - The drug also holds Orphan Drug Designation from the EMA for the same indications [5]. Clinical Trials - The company has initiated the MIRACLE trial, a Phase 3 study evaluating Annamycin in combination with cytarabine for relapsed or refractory AML [7]. - Following a successful Phase 1B/2 study, the company believes it has reduced risks associated with the development pathway for Annamycin's approval [7].