TURKU, FI / ACCESS Newswire / May 27, 2025 / Faron Pharmaceuticals (HEL:FARON)(LSE:FARN) - New preclinical data published in Scientific Reports confirms CLEVER-1 inhibition by Bexmarilimab increases antigen presentation and overcoming resistance to standard-of-care drugs
Study highlights:
Ex vivo treatment of AML and MDS bone marrow samples with bexmarilimab led to increased antigen-presenting human leukocyte antigen DR isotype (HLA-DR) expression, indicating improved antigen presentation capacity.
Bexmarilimab , when combined with azacitidine or venetoclax, enhanced HLA-DR expression and in many samples, reduced the viability of leukemic blasts, particularly in venetoclax-resistant samples.
The triple combination of bexmarilimab + azacitidine + venetoclax showed greater anti-leukemic effect in resistant AML cell lines than standard treatments alone.
Turku, Finland - Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company developing novel immunotherapies, today announced the publication of a new peer-reviewed preclinical study in Scientific Reports , validating the immune-reprogramming and anti-leukemic potential of its investigational macrophage CLEVER-1 inhibitor, bexmarilimab , in acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS).
The study, conducted in collaboration with leading Finnish and Danish academic research centers, examined AML cell lines and bone marrow samples from patients with AML (n = 34) and MDS (n = 4) and showed that CLEVER-1 is highly expressed on malignant myeloid cells, especially in AML with monocytic differentiation.
Immunotherapy treatments have revolutionized the treatment of many cancers but remain largely ineffective in AML and MDS due to immune resistance. Bexmarilimab addresses these challenges by reactivating the immune environment at its source (i.e. macrophages) and targeting CLEVER-1 directly on leukemic blasts. This approach represents a novel therapeutic avenue in myeloid malignancies where effective treatments are urgently needed.
CLEVER-1, a scavenger receptor involved in immunosuppression, was found to be highly expressed on immature myeloid cells and their monocytic derivatives, particularly in AML cases with M4-M5 FAB subtypes and in Fms Related Receptor Tyrosine Kinase 3 (FLT3) and/or Nucleophosmin 1 (NPM1) mutations.
"Our results show that CLEVER-1 is not only a macrophage checkpoint but also expressed on malignant myeloid cells and targeting it with bexmarilimab can enhance antigen presentation and sensitize these cells to standard therapies. These findings highlight a compelling opportunity to integrate bexmarilimab into standard treatment regimens for AML and MDS," said Dr. Maija Hollmén, Chief Scientific Officer of Faron and senior author of the study, MediCity Research Laboratory and InFLAMES Flagship, University of Turku, Turku, Finland.
Using ex vivo models, the team evaluated the effects of bexmarilimab , alone and in combination with standard-of-care therapies azacitidine and venetoclax, on immune activation and cell viability. Bexmarilimab monotherapy increased the expression of antigen-presenting HLA-DR by 1.2- to 2-fold in up to 66% of patient samples, especially in those with low baseline expression and high CLEVER-1 levels, without any cytotoxic effects on the blast cells, via potentially inducing interferon gamma (IFNg). Addition of bexmarilimab helped overcome venetoclax-resistance in 33-40% of ex vivo AML samples, without adding to lymphocyte toxicity. Moreover, the triplet of bexmarilimab, azacitidine, and venetoclax showed enhanced cytotoxicity in ex vivo models of treatment-resistant AML; suggesting that bexmarilimab increases the susceptibility to venetoclax and/or azacitidine induced cell death.
"This is an important milestone in our mission to bring the benefits of macrophage checkpoint inhibition to patients with hematological cancers like AML and MDS, especially after disease relapse," said Dr. Juho Jalkanen, CEO of Faron Pharmaceuticals. "The results strongly support the clinical rationale for combining bexmarilimab with standard therapies and also offer compelling evidence that our approach is both scientifically robust and clinically relevant, guiding the continued advancement of our BEXMAB trial."
The ongoing BEXMAB clinical study is currently evaluating bexmarilimab in combination with azacitidine in relapsed/refractory AML and MDS patients. The trial's most recent phase II data, to be presented at ASCO and EHA 2025, showed promising response rates in pretreated populations.
Faron will be hosting a virtual webinar to discuss the full analysis of r/r MDS as well as new frontline HR MDS patient data on Monday, 2 June 2025. To register for the event visit: BEXMAB Phase II study results
For more information, please contact:
IR Partners, Finland | +358 44 313 5005 |
FINN Partners, US | +1 847 791-8085 |
Cairn Financial Advisers LLP | +44 (0) 207 213 0880 |
Sisu Partners Oy | +358 (0)40 555 4727 |
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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