Presentation to include the first full pharmacokinetic and pharmacodynamic (PK/PD) data from the BEXMAB study; supports bexmarilimab's advancement into Phase III
TURKU, FI / ACCESS Newswire / July 30, 2025 / Faron Pharmaceuticals Ltd. (AIM:FARN)(First North:FARON), a clinical-stage biopharmaceutical company developing novel immunotherapies, announces that new clinical and translational data from the Phase I/II BEXMAB study evaluating bexmarilimab in combination with azacitidine in higher-risk myelodysplastic syndromes (HR-MDS) will be presented as a part of a Mini Oral Abstract Session at the 2025 European Society for Medical Oncology (ESMO) Congress, taking place from October 17-21, 2025, in Berlin, Germany.
The oral presentation, by Dr. Amer Zeidan, MBBS, MHS, Professor of Medicine and Chief of Hematologic Malignancies at Yale School of Medicine and Yale Cancer Center , will feature the first full disclosure of pharmacokinetic (PK) and pharmacodynamic (PD) data from the BEXMAB study. These results will be presented alongside promising efficacy and biomarker findings, which indicate bexmarilimab's potential to address a significant unmet need in HR-MDS, a condition with a poor prognosis.
The data from both frontline and relapsed/refractory (r/r) patient cohorts demonstrates that bexmarilimab, a novel macrophage checkpoint inhibitor targeting Clever-1, induces significant immune activation and hematological improvement within the bone marrow. This includes an increase in the antigen presentation capacity of monocytes and a rise in CD8+ T cells. These biological changes correlate with promising overall response rates of 85% in frontline and 63% in r/r patients with HR-MDS, and a median overall survival of 13.4 months in the latter group.
"HR-MDS is a devastating disease with limited effective treatment options," said Dr. Petri Bono, Chief Medical Officer of Faron. "The BEXMAB data to be presented at ESMO annual meeting, the flagship event of ESMO and one of the largest global cancer congresses, provides a comprehensive overview of bexmarilimab's activity, combining promising efficacy with a deep dive into its pharmacokinetic and pharmacodynamic profile. These findings reinforce our belief that targeting Clever-1 is the right approach and supports the advancement of bexmarilimab into Phase III trials, offering a potential new therapeutic strategy for these patients."
The findings support a dual mechanism of action for bexmarilimab with direct metabolic effects on malignant blasts and a powerful, immune-mediated response. By reprogramming macrophages, bexmarilimab remodels the bone marrow and tumor microenvironment, overcoming immune and myelosuppression.
Faron's presence at ESMO 2025 reinforces the Company's commitment to advancing science-driven novel immunotherapy solutions and to addressing unmet medical needs in oncology.
The details of the oral presentation are as follows:
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Presentation title | Macrophage reprogrammer Bexmarilimab Plus Azacitidine in Myelodysplastic Syndrome: PK/PD and biomarker results from the Phase I/II BEXMAB Study |
Session type and title | Mini Oral Abstract Session |
Presented by | Dr. Amer Zeidan |
Session date & Time | Oct 19, 2025 (8.30 to 10.00 am) |
Abstract no. | 1249MO |
For more information, please contact:
IR Partners, Finland | +358 44 313 5005 |
FINN Partners, US | +1 847 791-8085 |
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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. Directly targeting Clever-1 could limit the replication capacity of cancer cells, increase antigen presentation, ignite an immune response, and allow current treatments to be more effective. Clever-1 is highly expressed in both AML and MDS and associated with therapy resistance, limited T cell activation and poor outcomes.
About bexmarilimab
Bexmarilimab is Faron's wholly owned, investigational immunotherapy designed to overcome resistance to existing treatments and optimize clinical outcomes, by targeting myeloid cell function and igniting the immune system. Bexmarilimab binds to Clever-1, an immunosuppressive receptor found on macrophages leading to tumor growth and metastases (i.e. helps cancer evade the immune system). By targeting the Clever-1 receptor on macrophages, bexmarilimab alters the tumor microenvironment, reprogramming macrophages from an immunosuppressive (M2) state to an immunostimulatory (M1) one, upregulating interferon production and priming the immune system to attack tumors and sensitizing cancer cells to standard of care.
About Faron Pharmaceuticals Ltd
Faron (AIM:FARN)(First North:FARON) is a global, clinical-stage biopharmaceutical company, focused on tackling cancers via novel immunotherapies. Its mission is to bring the promise of immunotherapy to a broader population by uncovering novel ways to control and harness the power of the immune system. The Company's lead asset is bexmarilimab , a novel anti-Clever-1 humanized antibody, with the potential to remove immunosuppression of cancers through reprogramming myeloid cell function. Bexmarilimab is being investigated in Phase I/II clinical trials as a potential therapy for patients with hematological cancers in combination with other standard treatments. Further information is available at www.faron.com .
SOURCE: Faron Pharmaceuticals
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