Core Insights - Moleculin Biotech, Inc. has been granted an Australian patent for preliposomal Annamycin lyophilizates, enhancing its global intellectual property portfolio with a base patent term extending until June 2040 [1][2] - Annamycin is being developed as a non-cardiotoxic anthracycline for treating acute myeloid leukemia (AML) and soft tissue sarcoma lung metastases, with potential applications for various other cancers [2][4] - The company has initiated the MIRACLE trial, a Phase 3 study evaluating Annamycin in combination with cytarabine for relapsed or refractory AML, following a successful Phase 1B/2 study [5] Patent and Intellectual Property - The newly granted Australian patent covers preliposomal Annamycin with improved stability and high purity, contributing to the company's competitive position in oncology [1][2] - The patent family includes expected Canadian patents and previously issued U.S. and European patents, with additional applications pending in major jurisdictions worldwide [2] Drug Development and Clinical Trials - 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 [3] - The MIRACLE trial aims to evaluate the efficacy of Annamycin in combination with cytarabine, which is expected to de-risk the development pathway towards potential approval [5] Additional Pipeline Candidates - The company is also developing WP1066, an immune/transcription modulator targeting various cancers, and WP1122, an antimetabolite for treating pathogenic viruses and certain cancer indications [6]
Moleculin Expands Global IP Portfolio with New Australian Patent for Annamycin