#USA #Houston #Moleculin Biotech #Annamycin #Phase 3 Trial

Moleculin Biotech Expands Annamycin Patent Portfolio

Moleculin Biotech, Inc. has recently announced significant progress in its patent strategy, enhancing the global exclusivity of its promising cancer treatment, Annamycin. This late-stage pharmaceutical company, listed on Nasdaq under the ticker MBRX, specializes in innovative therapies for challenging tumors and viral infections. The company has received a Notice of Intent to Grant for a European patent application titled "Method of Reconstituting Liposomal Annamycin," which is expected to bolster its intellectual property position in major markets beyond the United States.

The granted patent will be pivotal in covering the methods of creating liposomal Annamycin suspensions and the resulting products intended for cancer treatments. With a potential patent term extending until June 2040, contingent upon fulfilling regulatory approval requirements, this new development aligns with the company's goal of establishing Annamycin as a groundbreaking, non-cardiotoxic anthracycline for the treatment of specific cancers.

Annamycin is being primarily developed for patients with acute myeloid leukemia (AML) and soft tissue sarcoma lung metastases (STS lung mets). Recent preclinical studies conducted at leading cancer research centers have suggested that Annamycin could potentially treat a wider range of cancers. Its unique lipid-based delivery system has displayed promise for targeting various malignancies.

Clinical Trial Progress

Moleculin is gearing up for the pivotal MIRACLE (Moleculin R/R AML AnnAraC Clinical Evaluation) Trial (designated MB-108), which will evaluate the efficacy of Annamycin in conjunction with cytarabine – a combination referred to as AnnAraC – for relapsed or refractory acute myeloid leukemia. This trial follows a successful Phase 1B/2 study (MB-106) and, with guidance from the FDA, the company believes it has reduced the risks associated with the development pathway towards potential approval.

The initial results from the MIRACLE trial are anticipated in the latter half of 2025. Wally Klemp, Chairman and CEO of Moleculin, expressed the significance of this patent acknowledgment by the European Patent Office, viewing it as a milestone in recognizing the innovation behind Annamycin. He highlighted that this patent exclusivity is critical as it supports the company’s strategy to commercialize Annamycin effectively in Europe, a key market for its expansion plans.

In addition to Annamycin, Moleculin is also advancing WP1066, an immune and transcription modulator targeting oncogenic transcription factors alongside stimulating natural immune responses, focusing on brain tumors and pancreatic cancers. The company is also engaged in an array of antimetabolite developments, including WP1122 for treating pathogenic viruses and various cancer applications.

Looking Ahead

Moleculin’s commitment to improving cancer treatment options is underscored by its proactive approach in securing intellectual property and advancing clinical trials. The upcoming data readouts and potential European market entry for Annamycin reflect the company’s strategic focus on delivering innovative cancer therapies to patients in need.

For more information on Moleculin and its ongoing projects, visit their website at www.moleculin.com, and follow the company on social media platforms like X, LinkedIn, and Facebook for the latest updates.

Disclaimer: This article contains forward-looking statements which involve risks and uncertainties. The company's ability to achieve projected milestones could be influenced by various factors, including regulatory approvals and capital resources. For detailed information regarding risk factors, please refer to Moleculin’s publicly filed documents with the SEC.