This acceptance marks the fifth major medical conference this year to feature bexmarilimab in an oral session, reinforcing the drug's unique mechanism in hematologic malignancies and potential to improve patient outcomes.
TURKU, FI / ACCESS Newswire / November 4, 2025 / Faron Pharmaceuticals Ltd. (HEL:FARON)(LSE:FARN), a clinical-stage biopharmaceutical company focused on developing novel treatments for medical conditions with significant unmet needs, today announced that two abstracts featuring data from the Phase 1/2 BEXMAB study have been accepted for presentation at the American Society of Hematology (ASH) 2025 Annual Meeting.
Highlighting the growing body of evidence for bexmarilimab, an abstract detailing the overall efficacy, molecular, and translational analysis of bexmarilimab in combination with azacitidine in patients with TP53-mutated (mTP53) higher-risk myelodysplastic syndromes (HR-MDS) has been selected for an oral presentation. This patient population has a particularly poor prognosis and represents a high unmet medical need. The second abstract, accepted as a poster presentation, reports on transfusion independence, hematological improvement, and associated safety outcomes from the BEXMAB study, further characterizing the clinically meaningful benefits and differentiated biology of the combination.
"The continued recognition of the bexmarilimab program by prestigious congresses like ASH is a testament to the strength and consistency of the data we are generating," said Dr. Juho Jalkanen, CEO of Faron. "The encouraging data in the challenging mutated TP53 patient population, underscores the potential of bexmarilimab to address a significant unmet need in hematologic malignancies. This marks a significant step forward in our mission to bring novel immunotherapies to patients who currently have very few options."
The presentation at ASH marks the fifth major international medical conference in 2025 where bexmarilimab data has been accepted for an oral presentation, following sessions at the MDS Foundation, the European Hematology Association (EHA) Congress, the European Society for Medical Oncology (ESMO) Congress, and the American Society of Clinical Oncology (ASCO) Annual Meeting.
Dr. Petri Bono, Chief Medical Officer of Faron, said, "These two datasets provide a compelling, dual narrative for bexmarilimab's activity that improves patient outcomes. The oral presentation highlights encouraging response rates in TP53-mutated HR-MDS, a notoriously difficult-to-treat disease where standard therapies fall short. Concurrently, the data on transfusion independence not only demonstrates a tangible quality-of-life benefit for patients but also correlates with a better safety profile and hematopoietic recovery. These findings reinforce our belief in bexmarilimab's unique mechanism to both fight the cancer and support the recovery of the patient's own blood cell production."
The Phase 1/2 BEXMAB study assessed impact of bexmarilimab plus azacitidine in patients with treatment-naive HR-MDS (n=21; 43% with mTP53) and those who have failed hypomethylating agent (HMA) therapy or relapsed/refractory (r/r) HR-MDS (n=32; 41% with mTP53). The BEXMAB abstract accepted for an oral demonstrates encouraging clinical activity in patients with treatment-naïve HR-MDS and mTP53 with an overall response rate (ORR) of 78% and a Composite Complete Response (cCR) rate of 44%. In the difficult-to-treat r/r HR-MDS subpopulation with mTP53, the combination achieved a 46% ORR and a median overall survival of 9.3 months. Overall, 6 (27%) of the patients with mTP53 received a stem cell transplant (the only curative treatment), of which four are still in follow-up.
Data from the second abstract shows that the combination enables hematopoietic recovery and supports excellent safety profile of bexmarilimab when combined with azacitidine. Of the frontline and r/r MDS patients who were transfusion independent (TI) before the study, 60% and 70%, respectively, maintained TI during bexmarilimab plus azacitidine treatment for =56 days. These hematological findings were associated with lower rate of adverse events and an increase in bone marrow progenitor cells that produce platelets and red blood cells after treatment.
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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
View the original press release on ACCESS Newswire:
https://www.accessnewswire.com/newsroom/en/biotechnology/faron-announces-two-bexmarilimab-abstracts-accepted-at-ash-2025-including-an-oral-pre-1096630