TURKU, FINLAND – Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), 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).

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.

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.

“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 currently working through the study design and institutional processes required to potentially move this forward.”

The scientific rationale for the proposed IIT is based on bexmarilimab’s ability to target the Clever-1 receptor expressed on immunosuppressive M2 macrophages and leukemic blasts. In the Phase I/II BEXMAB trial evaluating bexmarilimab in combination with azacitidine, encouraging response rates and overall survival were observed in participants with r/r MDS. The potential use of an oral HMA backbone may offer a more convenient treatment approach, pending further clinical evaluation.

“This potential collaboration with City of Hope reflects continued external investigator interest in bexmarilimab,” said Dr. Petri Bono, Chief Medical Officer of Faron. “Data generated from an independent investigator-initiated trial, could provide additional clinical and biological insights into bexmarilimab’s activity in r/r MDS.”

“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 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,” continued Dr. Juho Jalkanen CEO of Faron .

About bexmarilimab

Bexmarilimab is Faron’s wholly owned, investigational immunotherapy designed to overcome resistance to existing treatments by targeting Clever-1, a receptor on immunosuppressive macrophages and malignant blasts. By inhibiting Clever-1, bexmarilimab reprograms the tumor microenvironment to ignite a potent anti-tumor immune response.

About BEXMAB

The BEXMAB study is an open-label Phase I/II clinical trial investigating bexmarilimab in combination with standard of care (SoC) in the aggressive hematological malignancies of acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). The primary objective is to determine the safety and tolerability of bexmarilimab in combination with SoC (azacitidine) treatment.

About Faron Pharmaceuticals Ltd.

Faron Pharmaceuticals (AIM: FARN, First North: FARON) is a global, clinical-stage biopharmaceutical company, focused on creating innovative cancer treatments that leverage the patient’s own immune system. The Company’s lead asset bexmarilimab is currently being investigated in Phase I/II clinical trial as a potential therapy for patients with hematological cancers in combination with other standard treatments.

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