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Faron and City of Hope in Process of Developing a Phase II Investigator-Initiated Trial of Bexmarilimab in Relapsed/Refractory MDS
Building on the clinical results of the BEXMAB trial, the IIT aims to evaluate bexmarilimab with an oral HMA backbone to further strengthen evidence of its efficacy in research participants with high-risk myelodysplastic syndrome (HR MDS) TURKU, FI ...
About this update from Faron Pharmaceuticals Oy
[{"type":"text","content":"Building on the clinical results of the BEXMAB trial, the IIT aims to evaluate bexmarilimab with an oral HMA backbone to further strengthen evidence of its efficacy in research participants with high-risk myelodysplastic syndrome (HR MDS)","length":238,"tagName":"p"},{"type":"text","content":"TURKU, FI / ACCESS Newswire / March 2, 2026 / Faron Pharmaceuticals Ltd. (HEL:FARON)(LSE:FARN), a clinical-stage biopharmaceutical company focused on developing novel immunotherapies for cancer, today announces that investigators at City of Hope, one of the largest and most advanced cancer research and treatment organizations in the United States, are in the process of developing a Phase II investigator-initiated clinical trial (IIT) in collaboration with Faron to evaluate bexmarilimab in participants with relapsed or refractory myelodysplastic syndrome (r/r MDS).","length":570,"tagName":"p"},{"type":"text","content":"The proposed open-label IIT is being designed by hematology investigators at City of Hope who are participating in Faron's ongoing Phase I/II BEXMAB trial. Based on their clinical experience with bexmarilimab in r/r MDS, the investigators are exploring a potential Phase II trial to evaluate bexmarilimab, Faron's macrophage-targeting anti-Clever-1 antibody, in combination with the oral hypomethylating agent (HMA) decitabine/cedazuridine.","length":448,"tagName":"p"},{"type":"text","content":"The primary objective of the IIT would be to further explore the clinical and immunologic effects of combining bexmarilimab with an oral HMA further strengthening the data set of bexmarilimab in last line HR MDS. Initiation of the IIT remains subject to completion of protocol development, which is currently in progress, as well as applicable regulatory and ethics approvals. Enrollment of the first participant is expected in the second half of 2026.","length":452,"tagName":"p"},{"type":"text","content":""Patients with r/r MDS face extremely limited treatment options," said Dr. Brian Ball, Assistant Professor, Division of Leukemia, Department of Hematology & Hematopoietic Cell Transplantation at City of Hope, and the proposed IIT's principal investigator. "Based on prior clinical observations with bexmarilimab in combination with azacitidine, we believe further investigation in this setting is warranted. We are ...