Faron Pharmaceuticals has collaborated with cancer research organisation City of Hope to develop a Phase II investigator-initiated trial for evaluating bexmarilimab in participants with relapsed or refractory myelodysplastic syndrome (r/r MDS).
The study aims to assess the clinical and immunologic effects of bexmarilimab, Faron’s macrophage-targeting anti–Clever-1 antibody, when combined with an oral hypomethylating agent (HMA), decitabine/cedazuridine.
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The open-label trial is being developed by City of Hope’s haematology investigators who are taking part in Faron’s ongoing Phase I/II BEXMAB study.
These investigators are leveraging their experience with bexmarilimab in r/r MDS as they explore this combination treatment approach.
The primary aim is to expand bexmarilimab’s data set in last line HR MDS.
This trial initiation will depend on the completion of protocol development and approval from relevant regulatory and ethics authorities. Protocol development is currently underway, with the first participant expected to be enrolled during the second half of 2026.
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By GlobalDataThe scientific rationale for this trial is based on bexmarilimab’s capability to target the Clever-1 receptor, which is present on immunosuppressive M2 macrophages and leukaemic blasts.
In Faron’s earlier Phase I/II BEXMAB trial, bexmarilimab combined with azacitidine demonstrated encouraging response rates and overall survival outcomes in r/r MDS participants.
Adding an oral HMA backbone may offer a more convenient treatment route, subject to further clinical evaluation.
Faron CEO Dr Juho Jalkanen said: “We are very pleased and supportive of this initiative from the investigators of City of Hope. There is a profound need for new treatment options in r/r MDS, and we continuously receive inquiries from patients and caregivers to access bexmarilimab after failure to front line treatment in HR MDS. Hopefully, this study will be able alleviate some of the pressing needs for new options in r/r MDS.”
In May 2024, Faron announced initial positive data from the Phase II segment of the BEXMAB clinical trial of bexmarilimab in combination with azacytidine in r/r MDS.
