Moleculin Receives Notice of Intent to Grant New European Patent for Annamycin

Core Viewpoint - Moleculin Biotech, Inc. has received a Notice of Intent to Grant for a European patent that will enhance its market position for Annamycin, a potential first non-cardiotoxic anthracycline, aimed at treating hard-to-treat tumors and viruses [2][3][4] Company Overview - Moleculin Biotech, Inc. is a late-stage pharmaceutical company focused on developing drug candidates for hard-to-treat tumors and viruses, with its lead program being Annamycin [5] - Annamycin is designed to avoid multidrug resistance and lacks the cardiotoxicity associated with current anthracyclines, currently in development for relapsed or refractory acute myeloid leukemia (AML) and soft tissue sarcoma lung metastases [5] Patent and Development - The new European patent will cover methods for creating a preliposomal Annamycin lyophilizate with improved stability and high purity, with a base patent term extending until 2040 [3][4] - Annamycin has received Fast Track Status and Orphan Drug Designation from the FDA for relapsed or refractory AML and STS lung metastases, as well as Orphan Drug Designation from the EMA [4] Clinical Trials - The company has initiated the MIRACLE Trial (MB-108), a pivotal Phase 3 trial evaluating Annamycin in combination with cytarabine for relapsed or refractory AML, following a successful Phase 1B/2 study [6] - The development pathway for Annamycin is considered substantially de-risked with input from the FDA [6] Additional Developments - Moleculin is also developing WP1066, an immune/transcription modulator targeting various cancers, and a portfolio of antimetabolites including WP1122 for potential treatment of pathogenic viruses and certain cancer indications [7]