Faron Pharmaceuticals has secured a significant extension to its intellectual property portfolio with the granting of US Patent No. 12,371,486 by the United States Patent and Trademark Office. The patent covers treatment of Clever-1 positive cancers with bexmarilimab and related structures, extending key patent rights around the investigational immunotherapy from 2037 to February 2040.
The newly granted patent represents a divisional application from Faron's original "composition of matter" patent covering bexmarilimab's structure. While the original patent included both composition matter claims and treatment methods, this new patent specifically focuses on treating cancers that have Clever-1 positive cells in the tumor microenvironment. The extended term beyond the standard twenty years reflects adjustments made due to the lengthy application process.
Clinical Focus on Hematological Malignancies
The patent extension holds particular significance for Faron's development of bexmarilimab in acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). According to CEO Juho Jalkanen, "This significantly extends our key patent life on the use of bexmarilimab for the treatment of relevant cancers, that have Clever-1 positive tumour associated macrophages or blasts cells, such as in AML & MDS."
Bexmarilimab is currently being investigated in the BEXMAB study, an open-label Phase I/II clinical trial examining the drug in combination with standard of care treatment. The trial focuses on aggressive hematological malignancies, with the primary objective of determining safety and tolerability of bexmarilimab combined with azacitidine treatment.
Mechanism of Action and Therapeutic Approach
The investigational immunotherapy works by targeting Clever-1, an immunosuppressive receptor found on macrophages that contributes to tumor growth and metastases. Clever-1 is highly expressed in both AML and MDS and is associated with therapy resistance, limited T cell activation, and poor clinical outcomes.
Bexmarilimab's mechanism involves reprogramming macrophages from an immunosuppressive M2 state to an immunostimulatory M1 state. This transformation upregulates interferon production and primes the immune system to attack tumors while sensitizing cancer cells to standard of care treatments. By directly targeting Clever-1, the therapy aims to limit cancer cell replication capacity, increase antigen presentation, and ignite immune responses that could make current treatments more effective.
Strategic Patent Portfolio
Jalkanen emphasized the strength of Faron's intellectual property position, stating, "The patent family around targeting Clever-1 in cancer is strong and we believe bexmarilimab will enjoy a long patent life once marketed, given how far it is in clinical development already."
The extended patent protection provides Faron with additional commercial runway for bexmarilimab, which represents the company's lead asset in its mission to bring immunotherapy benefits to broader patient populations. As a clinical-stage biopharmaceutical company focused on novel immunological pathways in cancer treatment, Faron is investigating bexmarilimab as a potential therapy for hematological cancer patients in combination with other standard treatments.