Faron Pharmaceuticals (HEL:FARON)(LSE:FARN) - Strong efficacy and survival outcomes with bexmarilimab in high-risk MDS support Phase III advancement
Median overall survival (mOS) of 13.4 months in r/r HR-MDS patients (n=32) treated with bexmarilimab + azacitidine; mOS of 9.3 months in TP53 mutated patients (n=13)
ORR of 85% and cCR of 50% in patients with frontline MDS (n=20)
Deep bone marrow responses demonstrated at all dose levels in frontline MDS and based on the safety and efficacy data of the trial, the recommended phase III bexmarilimab dose is 3 mg/kg
Turku, Finland- Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company advancing next-generation immunotherapies, presents detailed phase II data from its ongoing BEXMAB study evaluating bexmarilimab in high-risk myelodysplastic syndromes (HR-MDS) as an oral presentation at the 30th European Hematology Association's (EHA) Congress, taking place in Milan from 12-15 June 2025.
The presentation will be led by Dr. Mika Kontro, Associate Professor at University of Helsinki and Helsinki University Hospital Comprehensive Cancer Center, Department of Hematology, and will contain detailed results from the study of bexmarilimab, Faron's investigational anti-Clever-1 antibody, in combination with azacitidine for patients with relapsed or refractory (r/r) and frontline or treatment-naïve HR-MDS. These results expand upon those presented at ASCO 2025 and reaffirm the efficacy and safety of bexmarilimab in this difficult-to-treat population.
Strong efficacy data in both r/r HR-MDS and frontline MDS, support advancement into phase III
The BEXMAB study evaluated bexmarilimab (1, 3, or 6 mg/kg weekly in 28-day cycles), a first-in-class monoclonal antibody targeting the Clever-1 receptor, in combination with azacitidine, a standard-of-care hypomethylating agent (HMA). By blocking Clever-1, bexmarilimab reprograms macrophages in the bone marrow, enhancing anti-tumor immunity.
With 80% of patients with r/r HR-MDS (n=32) falling in the very high/high risk category at baseline, the phase II BEXMAB data demonstrated an estimated median overall survival (mOS) of approximately 13.4 months, significantly surpassing historical outcomes of 5-6 months expected under standard of care. A mOS of 9.3 months was observed in patients with the aggressive mTP53 mutation (n=13). Five patients in the r/r HR-MDS group proceeded to stem cell transplant (SCT), the only curative option. Of the non-mTP53 mutated patients mOS has not yet been reached and 15 out of 19 patients are still alive.
Dr. Mika Kontro, MD, PhD, also the principal investigator of the BEXMAB study, said, "The consistent and durable responses observed with bexmarilimab are notable in this patient population. The survival data with bexmarilimab are encouraging for r/r HR-MDS patients, who have limited treatment options after failing HMA therapy."
In an updated analysis compared to the ASCO data, patients with frontline MDS (n=20; 45% with the TP53 mutation), the combination of bexmarilimab with azacitidine demonstrated an ORR of 85% and a cCR of 50%. In those with TP53, the ORR and cCR were 78% and 44%, respectively. In this group too, 7(35%) patients proceeded to SCT (n=5) or are in planning for transplant (n=2). Though bone marrow responses were observed across all dose levels in these patients, the 3 mg/kg appeared to be more favourable at this early stage, indicating the use of this dose for further trials.
Dr. Petri Bono, Chief Medical Officer of Faron, said, "Achieving this milestone underscores our commitment to addressing the urgent needs of MDS patients. These results support ongoing positive and pivotal discussions with regulatory authorities. We are dedicated to advancing bexmarilimab through clinical development into phase III, with the goal of offering new hope to patients suffering from HR-MDS."
Favourable immune activation with 3 mg/kg bexmarilimab dose
According to new data to be presented at EHA, bexmarilimab showed CLEVER-1 target engagement in both blood and bone marrow across all doses with no indication of accumulation with repeated dosing. Favourable activation of both the adaptive and innate immune system indicators was seen in r/r HR-MDS and frontline MDS with 3 mg/kg bexmarilimab and azacitidine. The combination was well-tolerated in all patients with HR-MDS.
The details of the oral presentation are as follows:
Presentation title: Efficacy of Macrophage Checkpoint Clever-1 Inhibition with bexmarilimab plus Azacitidine in Myelodysplastic Syndrome: Results from the Ph1/2 BEXMAB Study
Session: Oral presentation
Presenter: Dr. Mika Kontro, MD, PhD
Date and Time: 15 June 2025 11:00 - 12:15 CEST
Location: Milan, Italy
Abstract no: S178
Faron Pharmaceuticals remains committed to accelerating the clinical development of bexmarilimab for patients with high-risk myeloid malignancies and anticipates initiating preparations for a Phase III registrational trial in the second half of 2025, following discussions with the FDA.
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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.
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SOURCE: Faron Pharmaceuticals
View the original press release on ACCESS Newswire:
https://www.accessnewswire.com/newsroom/en/biotechnology/faron-pharmaceuticals-presents-updated-phase-ii-data-from-bexmab-study-at-eha-2025-1038707
