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news.The US Patent and Trademark Office (USPTO) has granted Moleculin Biotech two additional patents with claims covering the company’s drug candidate Annamycin.
The drug is under development for treating acute myeloid leukaemia and soft tissue sarcoma lung metastases (STS lung mets). Credit: Lucas Vasques on Unsplash.
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These patents have a base patent term extending until June 2040.
This is contingent upon the alteration due to any delays in the prosecution process and extension to compensate for the duration needed to obtain regulatory approvals.
US patent number 12,257,261, titled “Preparation of Preliposomal Annamycin Lyophilizate,” outlines the process for creating liposomal Annamycin.
The second patent, US patent number 12,257,262, titled “Method of Reconstituting Liposomal Annamycin,” details the method for making a liposomal Annamycin suspension.
The company is in the process of seeking further patents for Annamycin in Europe, the US, and other key regions across the globe.
The company noted that Annamycin is being positioned to become the first anthracycline free of cardiotoxicity to be approved.
It is under development for the treatment of acute myeloid leukaemia (AML) and soft tissue sarcoma lung metastases (STS lung mets).
The new chemical entity is said to employ a lipid-based delivery technology, which has shown promise for use in various cancers.
The drug has already received fast track status and orphan drug designation from the Food and Drug Administration (FDA) for treating relapsed or refractory AML. It also holds an orphan drug designation for treating STS lung mets.
Additionally, the European Medicines Agency (EMA) has granted an orphan drug designation for the drug for treating relapsed or refractory AML.
Moleculin Biotech CEO and chairman Wally Klemp said, “Following the issuance of two US patents in 2024, these new patents enhance the exclusivity of Annamycin, bringing to four the total number of US patents related to Annamycin, in addition to the European patents granted.
“Based on the data seen to date and feedback we continue to receive from clinicians and patients, we are dedicated to advancing this important and much-needed treatment option forward.”
