Bexmarilimab targets a novel mechanism
Bexmarilimab has a novel mechanism targeting the Common Lymphatic Endothelial and Vascular Endothelial Receptor-1 (Clever-1), a protein that is involved in various physiological processes, including immune responses and inflammation.
Clever-1 has been found to play a role in cancer progression, as well as in the development of various diseases, such as asthma and arthritis. Targeting Clever-1 reprograms immunosuppressive macrophages to tumor-suppressive macrophages, allowing for potential efficacy in combination with anticancer therapies.
We are leading the immunotherapy space
The precise therapeutic control of myeloid malignancies and cancer-related immunosuppression remains a critically unmet challenge that has not been successfully mastered with the current arsenal of drugs.
Targeting Clever-1, expressed by both immunosuppressive macrophage populations and myeloid leukemia cells, presents a way to address two populations.
What our treatments can offer
Faron is leading the science in the macrophage checkpoint inhibitor space, with positive safety demonstrated in our Phase I/II MATINS testing bexmarilimab as a monotherapy, and the Phase I/II BEXMAB study in hematological malignancies, combined with standard-of-care treatment.
We have demonstrated objective responses in the BEXMAB study, with long durations of treatment and at least one patient undergoing potentially curative transplantation. We plan to test bexmarilimab in the Phase I/II BEXCOMBO study in solid tumors.
The potential opportunity of our cancer immunotherapy
Faron’s Phase I/II MATINS trial, investigating the potential of bexmarilimab monotherapy in ten advanced, treatment-resistant solid tumor types, in over 200 patients, generated a wealth of positive safety and efficacy data.
The trial showed a meaningful extension of life among patients who benefited from bexmarilimab monotherapy, and it has laid the groundwork for the Company’s broader development program and multiple potential routes to market.
How we stand out
Faron’s current priority in the combination setting is its Phase I/II BEXMAB trial, investigating bexmarilimab in combination with standard-of-care therapies in relapsed/refractory acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS).
The latest data from the trial are a powerful indication of the therapeutic potential of bexmarilimab in hematological malignancies with bexmarilimab well tolerated across the trial and efficacy signals across all patient cohorts (an increasing bexmarilimab dose and in combination with azacitidine as a doublet, and azacitidine + venetoclax as a triplet therapy).
Pipeline progress
The Phase I/II BEXMAB clinical study is looking at the safety, tolerability and preliminary efficacy of bexmarilimab in combination with standard of care therapies azacitidine, and azacitidine +venetoclax, and will identify the recommended dose for the Phase II part of the trial.
In the most recent data readout, three of five patients in the 6 mg/kg bexmarilimab + azacitidine doublet cohort achieved objective responses; eight of 15 objective responses were observed in all three doublet dosing cohorts and one patient has stayed on treatment for 13 months.
The updated BEXMAB data supports advancement to Phase II in H2 2023 focusing on standard of care relapsed/refractory AML and MDS patients failing hypomethylating agents (HMA). Faron plans to seek FDA advice during Q3 2023 on its potential path to submitting a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) in H1 2025.