On July 30, 2025 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a late-stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat tumors and viruses, reported it has received a Notice of Intent to Grant for the European patent application titled, "PREPARATION OF PRELIPOSOMAL ANNAMYCIN LYOPHILIZATE (Press release, Moleculin, JUL 30, 2025, View Source [SID1234654639])." Such grant should solidify the Company’s European Union exclusivity of Annamycin, also known by its non-proprietary name of naxtarubicin, with the potential to become the first non-cardiotoxic anthracycline.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
The grant is subject to payment of fees and completion of final amendments and formalities. When issued, the patent claims will cover methods of making a preliposomal Annamycin lyophilizate with improved stability and high purity, with a base patent term currently extending until into 2040, subject to extension to account for time required to fulfill requirements for regulatory approval. Moleculin’s novel drug candidate is being positioned to become the first ever non-cardiotoxic anthracycline to be approved and is currently being developed for the treatment of acute myeloid leukemia (AML) and soft tissue sarcoma lung metastases (STS lung mets). Additional preclinical studies performed at a world-renowned cancer center indicate Annamycin may be a potential treatment for many other types of cancers. The new chemical entity uses a unique lipid-based delivery technology and has shown the potential to be used in a wide range of cancers. In addition to the newly expected European patent and previously issued U.S. patents, Moleculin has additional patent applications related to Annamycin pending in the U.S., Europe and in major jurisdictions worldwide.
Walter Klemp, Chairman and CEO of Moleculin, said, "Our preliposomal formulation for Annamycin not only improves the stability and usability of Annamycin, but also creates a scalable platform that has the potential to be a catalyst for how lipophilic oncology drugs are delivered. We are pleased to add this newly granted European patent to our global intellectual property portfolio and believe it provides further validation of Annamycin’s potential. The current patent portfolio includes patents and patent applications with claims to methods of making our preliposomal Annamycin and liposomal Annamycin suspension as well as the resulting compositions for use in the treatment of cancers in the US, Europe, China, and India, among others. We remain committed to fortifying our global patent protection for Annamycin and advancing the development of this potentially transformative therapeutic candidate for hard-to-treat tumors."
Annamycin (naxtarubicin), currently has 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 mets. Furthermore, Annamycin has Orphan Drug Designation for the treatment of relapsed or refractory acute myeloid leukemia from the EMA.