On October 29, 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 cancers and viral infections, reported that the Australian Patent Office (IP Australia) has granted Patent No. 2024203598 titled, "PREPARATION OF PRELIPOSOMAL ANNAMYCIN LYOPHILIZATE," with claims covering certain preliposomal Annamycin lyophilizates with improved stability and high purity, with a base patent term currently extending until June 2040, subject to extension to account for time required to fulfill requirements for regulatory approval. This patent further expands the Company’s intellectual property portfolio globally.
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Walter Klemp, Chairman and CEO of Moleculin, commented, "As we continue our mission to provide patients with Annamycin, a potentially transformative therapeutic candidate for hard-to-treat tumors, we remain focused on building our global patent protection to strengthen our competitive moat in oncology and bolster our position as a leader in the space. I am proud of our team’s diligent work in securing patent protection across key markets, and adding this Australian patent to our growing global IP portfolio underscores our commitment and belief in the potential of Annamycin. We remain encouraged by the data demonstrated by Annamycin to date and look forward to its continued advancement."
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 granted Australian patent, this patent family relating to the preparation of preliposomal Annamycin includes an expected Canadian patent and previously issued U.S. and allowed European patents. Moleculin also has additional patent applications related to Annamycin pending in the U.S., Europe and in major jurisdictions worldwide.
Annamycin, also known by its non-proprietary name of 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 AML from the EMA.
(Press release, Moleculin, OCT 29, 2025, View Source [SID1234657107])