Core Insights - Moleculin Biotech, Inc. has received a Notice of Intent to Grant for a European patent for its drug candidate Annamycin, which is aimed at treating certain cancers and is expected to enhance global exclusivity [1][2][3] - The company anticipates an initial data readout from the phase 3 MIRACLE trial in the second half of 2025, which evaluates Annamycin in combination with cytarabine for relapsed or refractory acute myeloid leukemia (AML) [1][3] Patent and Market Expansion - The new patent will cover methods for making liposomal Annamycin suspension and its compositions for cancer treatment, with a base patent term extending until June 2040, potentially longer due to regulatory approval processes [2] - Annamycin is positioned to be the first non-cardiotoxic anthracycline approved for use, with ongoing studies suggesting its potential for treating various cancer types [2] Clinical Development - The MIRACLE trial (MB-108) is a pivotal phase 3 study that follows a successful phase 1B/2 study, indicating a de-risked development pathway for Annamycin's approval for AML treatment [3] - The company is also developing WP1066, an immune/transcription modulator targeting brain tumors and other cancers, along with a portfolio of antimetabolites for treating pathogenic viruses and certain cancer indications [4]
Moleculin Announces Additional Annamycin Patent Allowances to Enhance Global Exclusivity