Medivir AB announced July 20 that it has received a Notice of Allowance from the United States Patent and Trademark Office for its patent application covering the combination of fostroxacitabine bralpamide (fostrox) with lenvatinib for the treatment of hepatocellular carcinoma and cancer metastases to the liver. The company said this patent, which adds to previous approvals in the European Union, Japan, Australia, and Canada, will provide protection and market exclusivity until at least April 2041.
According to Jens Lindberg, CEO of Medivir, "This Notice of Allowance for the fostrox plus lenvatinib combination is, together with the fostrox composition of matter patent, part of our strategy to protect clinically relevant combinations with fostrox in liver cancer. The notice provided by USPTO is especially critical considering the commercial importance of the US market and further confirms the innovative features of the fostrox plus lenvatinib combination."
Fostrox is described as a liver-targeted inhibitor of DNA replication that delivers a cell-killing compound selectively to tumors while minimizing effects on normal cells. The company said fostrox is designed to be administered orally and activated locally in the liver, which may allow it to become the first liver-targeted, orally administered drug for patients with primary liver cancer and liver metastases from other tumor types. A phase 1b monotherapy study with fostrox established clinical proof-of-concept, and a phase 1b/2a combination study with fostrox and Lenvima in advanced hepatocellular carcinoma was completed in November 2024, with data showing encouraging anti-cancer efficacy and a good safety and tolerability profile, according to Medivir.
Primary liver cancer is the third leading cause of cancer-related deaths worldwide. Hepatocellular carcinoma is the most common form of liver cancer and is the fastest growing cancer in the United States. Although existing therapies for advanced hepatocellular carcinoma can extend patient lives, treatment benefits are limited and death rates remain high. There are approximately 860,000 new cases of primary liver cancer diagnosed globally each year, and the current five-year survival rate is less than 20 percent, according to Medivir.
Medivir is a pharmaceutical company focused on developing therapies for diseases with high unmet medical need. Its lead programs include fostrox, a precision chemotherapy for liver cancer, and MIV-711, which targets Osteogenesis Imperfecta and Legg-Calvé-Perthes disease. The company is listed on the Small Cap segment of Nasdaq Stockholm. More information is available at www.medivir.com.
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