Faron Shares Positive Phase 2 BEXMAB Trial Data at ASH Meeting

Faron Pharmaceuticals Ltd., a biopharmaceutical company at the forefront of developing innovative cancer immunotherapies, has revealed promising data from its ongoing Phase 2 interim analysis at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition. This event was hosted in San Diego, California, and virtually from December 7 to 10, 2024.

The focal point of the presentation was the BEXMAB study, which investigates the efficacy of bexmarilimab, an innovative anti-Clever-1 humanized antibody, in combination with standard treatments for patients with aggressive myeloid leukemias. Specifically, the study targets patients with relapsed or refractory myelodysplastic syndrome (MDS), a demographic that presents a significant therapeutic challenge due to the limited success of existing standard care, especially in those with TP53 mutations and patients who have not responded to hypomethylating agents (HMA).

Dr. Juho Jalkanen, Faron's Chief Executive Officer, expressed optimism about the study's results, highlighting an impressive 80% overall response rate (ORR) in patients with relapsed or refractory MDS. According to Dr. Jalkanen, this combination therapy is not only well-tolerated, but it also results in substantial and enduring reductions in cancerous cells as well as improvements in the patients' hematological profiles. These findings affirm bexmarilimab's unique mechanism of action, which aims to reprogram myeloid cells and enhance the treatment of MDS. This evidence paves the way for advancing to a full Phase 2 efficacy analysis and engaging in further regulatory discussions to streamline the pathway for a Biologics License Application (BLA) filing.

Dr. Mika Kontro, the Principal Investigator for the BEXMAB trial and an associate professor at the Helsinki University Hospital Comprehensive Cancer Center, underscored the promising nature of the data presented at ASH. He emphasized the notable improvements in both overall response rate and overall survival among the patient cohort, which he believes represent significant steps forward in addressing the therapeutic challenges posed by refractory MDS.

The BEXMAB study is a multicenter clinical trial conducted in Finland, the UK, and the United States. Its primary goal is to evaluate the safety and efficacy of bexmarilimab when combined with standard care treatments such as azacitidine. By targeting the Clever-1 receptor, which is highly expressed in acute myeloid leukemia (AML) and MDS, bexmarilimab aims to limit the cancer cells' replication, enhance antigen presentation, and ignite an immune response that could potentially increase the efficacy of existing treatments.

Bexmarilimab itself is a proprietary immunotherapy developed by Faron Pharmaceuticals. It functions by targeting and binding to Clever-1, an immunosuppressive receptor on macrophages that contributes to tumor progression by helping cancer evade the immune system. By reprogramming these macrophages from an immunosuppressive to an immunostimulatory state, bexmarilimab boosts interferon production and primes the immune system to attack tumors, thereby sensitizing cancer cells to standard care treatments.

Faron Pharmaceuticals Ltd., listed on both AIM and First North, is a global biopharmaceutical entity committed to advancing cancer treatments through novel immunotherapeutic strategies. The company's goal is to leverage the power of the immune system to improve the clinical outcomes for a broader patient population, as demonstrated by the promising developments of their lead asset, bexmarilimab. The ongoing success of the BEXMAB study reaffirms Faron's dedication to pioneering treatments that effectively combat hematological malignancies.