Encouraging Phase 1 BEXMAB Study Results in High-Risk MDS and r/r AML Patients

Recent updates from the BEXMAB clinical trial indicate a positive trend in the treatment of high-risk (HR) myelodysplastic syndrome (MDS) patients who have not responded to hypomethylating agents (HMA). The trial, which has transitioned into Phase 2, has shown that a significant number of patients are still in remission after eight months, suggesting a promising survival benefit when compared to existing treatments. The initial Phase 1 cohort, consisting of HR HMA-failed MDS patients, demonstrated an 87.5% overall response rate, with responses ranging from complete remission to stable disease, despite one patient discontinuing due to a serious adverse event unrelated to the study drug.

The ongoing BEXMAB study, led by Principal Investigator Mika Kontro, MD, PhD, from the Helsinki University Hospital Comprehensive Cancer Center, is assessing the safety and efficacy of bexmarilimab in combination with the standard of care, azacitidine. Bexmarilimab, developed by Faron Pharmaceuticals Ltd., is an experimental immunotherapy that targets the Clever-1 receptor on macrophages, potentially enhancing the immune system's ability to combat cancer cells.

Faron Pharmaceuticals will host a virtual webinar on March 19 to delve into these findings. The company's CEO, Dr. Markku Jalkanen, expressed optimism about the potential of bexmarilimab to significantly improve patient outcomes, particularly for those suffering from aggressive forms of cancer. The data from the BEXMAB trial are expected to be instrumental in future discussions with regulatory authorities, such as the FDA, to advance the treatment's approval process.

The study's design focuses on the aggressive hematological malignancies of AML and MDS, with the primary goal of establishing the safety profile of bexmarilimab when combined with standard treatments. The drug's mechanism of action involves targeting Clever-1, which is highly expressed in both AML and MDS and is linked to therapy resistance and poor patient outcomes.

Faron Pharmaceuticals, a clinical-stage biopharmaceutical company, is dedicated to developing novel immunotherapies to address various cancers. Their lead asset, bexmarilimab, represents a new approach to cancer treatment by reprogramming myeloid cell function and activating anti-tumor immunity.

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