Faron Pharmaceuticals (FARN) ESMO 2025 Conference summary

Key clinical findings and trial data

• Bexmarilimab plus azacitidine achieved an 85% objective response rate and 45% complete remission rate in treatment-naive higher-risk MDS patients, with 55% showing full clearance of bone marrow blasts and 100% ORR in those with <5% blasts at baseline.

• In relapsed/refractory HMA-failed patients, the combination achieved a 63% ORR and median overall survival of 13.4 months.

• 23% of patients across the study were successfully bridged to potentially curative allogeneic transplantation.

• The therapy demonstrated robust activity in high-risk mutations, including a 78% ORR in TP53-mutated cases.

• Bexmarilimab demonstrated a favorable safety profile compared to other agents, with lower rates of severe adverse events and improved hematopoiesis.

Pharmacodynamic and biomarker insights

• Higher Clever-1 target engagement correlated with better responses, especially in patients with low blast counts, who achieved a 100% response rate.

• New biomarker data revealed a strong correlation between Clever-1 engagement and clinical response (p=0.0006).

• Translational data confirmed bexmarilimab's efficacy is linked to higher target engagement in responders.

• The biomarker impact provides a clear rationale for the observed clinical efficacy and helps identify patients most likely to benefit.

• The therapy's mechanism involves reprogramming macrophages to enhance anti-tumor immunity.

Mechanism of action and study background

• Bexmarilimab is a monoclonal antibody targeting Clever-1, reprogramming macrophages from an immunosuppressive to an immunostimulatory state.

• Bexmarilimab activates macrophages and T-cells, impairs blast cell metabolism, and increases hematopoiesis, supporting faster hematological recovery.

• The drug's unique mechanism allows efficacy in low blast count patients, a group where other agents like venetoclax have failed.

• The BEXMAB study is an open-label Phase I/II trial in AML and MDS, aiming to determine safety and efficacy in combination with standard of care.

• Preclinical data in mice support improved recovery from chemotherapy when treated with bexmarilimab.