Faron and City of Hope Collaborate on Phase II Trial for Relapsed/Refractory Myelodysplastic Syndrome
TURKU, FINLAND – Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON) announced today that investigators at City of Hope, a leading cancer research and treatment center, are developing a Phase II investigator-initiated trial (IIT) to evaluate bexmarilimab in patients with relapsed or refractory myelodysplastic syndrome (r/r MDS). The trial will explore bexmarilimab in combination with decitabine/cedazuridine, an oral hypomethylating agent (HMA).
Understanding Myelodysplastic Syndrome and the Require for New Treatments
Myelodysplastic syndromes (MDS) are a group of blood cancers in which the bone marrow does not produce enough healthy blood cells. Relapsed or refractory MDS, where the disease returns after treatment or doesn’t respond to initial therapy, presents a significant challenge for patients, with limited treatment options available.
Bexmarilimab: A Novel Immunotherapy Approach
Bexmarilimab is Faron’s investigational immunotherapy designed to target Clever-1, a receptor found on immunosuppressive macrophages and malignant blasts. By inhibiting Clever-1, bexmarilimab aims to reprogram the tumor microenvironment and enhance the body’s immune response against cancer cells.
Trial Design and Objectives
The open-label IIT is being designed by hematology investigators at City of Hope, who are also participating in Faron’s ongoing Phase I/II BEXMAB trial. The primary objective of the trial is to further evaluate the clinical and immunologic effects of combining bexmarilimab with an oral HMA, building upon existing data from the BEXMAB trial, which showed encouraging response rates and overall survival in patients with r/r MDS when bexmarilimab was combined with azacitidine.
Expert Perspectives
“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.”
Dr. Petri Bono, Chief Medical Officer of Faron, added, “This potential collaboration with City of Hope reflects continued external investigator interest in bexmarilimab. Data generated from an independent investigator-initiated trial could provide additional clinical and biological insights into bexmarilimab’s activity in r/r MDS.”
Dr. Juho Jalkanen, CEO of Faron, stated, “There is a profound need for new treatment options in r/r MDS and we continuously receive inquiries from patients and care givers to access bexmarilimab after failure to frontline treatment in HR MDS. Hopefully, this study will be able alleviate some of the pressing need for new options in r/r MDS.”
Looking Ahead
Initiation of the IIT is contingent upon completion of protocol development, regulatory approvals, and ethics approvals. Enrollment of the first participant is anticipated in the second half of 2026. Faron is also planning a rights offering of approximately EUR 40 million to strengthen its capital structure and support the development of bexmarilimab.