Faron Announces Five ASH 2026 Abstracts Spann...

Faron Pharmaceuticals Ltd | Press Release | November 04, 2026 at 16:20:00 EET

Abstracts include clinical, translational and biomarker findings in higher-risk MDS, a new post-hypomethylating agent survival benchmark, and the randomized Phase 2b BEXERA trial in progress

TURKU, FINLAND – Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a global, clinical-stage biopharmaceutical company focused on creating innovative cancer treatments that leverage the patient’s own immune system, today announces that five abstracts spanning its bexmarilimab program, Clever-1 biology and outcomes in higher-risk myelodysplastic syndrome (HR-MDS) have been accepted for presentation at the 68th American Society of Hematology (ASH) Annual Meeting and Exposition, taking place in New Orleans, Louisiana, 12–15 December 2026.

Together the abstracts form a connected body of evidence in HR-MDS: the full overall survival dataset from the Phase 1/2 BEXMAB trial in both frontline and relapsed/refractory disease, including survival by TP53 allelic state, new translational analyses describing how bexmarilimab plus azacitidine remodels the bone marrow and which patients respond, non-clinical evidence that Clever-1 blockade supports hematopoietic regeneration, a systematic review establishing a contemporary overall survival (OS) benchmark after hypomethylating agent (HMA) failure, and the design of the randomized Phase 2b BEXERA trial in treatment-naïve HR-MDS.

“Once hypomethylating agent therapy fails in higher-risk MDS there is no approved option left and outcomes are poor across the board, so a median overall survival of 18.7 months in patients with wild-type TP53 is a striking result. Even in TP53-mutated patients, who face the poorest outlook in this disease, the medians we are seeing are encouraging. As the dataset matures, the picture of which patients benefit is becoming clearer,” said Mika Kontro, MD, Associate Professor at the University of Helsinki and Helsinki University Hospital Comprehensive Cancer Center, Principal Investigator of the BEXMAB trial and presenting author of the survival abstract.

BEXMAB clinical results in frontline HR-MDS

As previously reported, in the treatment-naïve cohort (n=20 evaluable) bexmarilimab plus azacitidine produced an overall response rate (ORR) of 85% and a complete remission (CR) rate of 45% per IWG 2006 criteria, with a median duration of CR of 16.1 months. Among patients achieving CR, 67% were minimal residual disease (MRD) negative by local flow cytometry.

The cohort contained a high proportion of patients with high-risk molecular features, which in HR-MDS predict shorter responses and inferior survival. Nearly half of patients (48%) carried a TP53 mutation, and 60% of those mutations were biallelic, the subgroup with the poorest expected outcomes in HR-MDS.

After a median follow-up of 15 months, median OS had not been reached in patients with wild-type TP53 or monoallelic TP53 mutations. The 12-month OS rate was 70% in wild-type TP53 patients and 40% in TP53-mutated patients. Median OS was 8.8 months in the biallelic TP53-mutated subgroup and 12.1 months across the full treatment-naïve cohort.

BEXMAB clinical results after HMA failure

In the relapsed/refractory cohort (n=33 evaluable), ORR was 64% per IWG 2006 criteria, including 12% CR or partial remission. Overall survival tracked TP53 status: median OS reached 18.7 months in patients with wild-type TP53, 10.9 months in those with monoallelic TP53 and 7.5 months in those with biallelic mutations. Across the full cohort, median OS was 11.2 months.

The safety profile of bexmarilimab added to azacitidine appeared comparable to azacitidine alone, with 59% of grade 3 or higher treatment-emergent adverse events being hematological. No grade 5 events were assessed by investigators as related to bexmarilimab.

A contemporary survival benchmark after HMA failure

Patients with HR-MDS have no approved treatment options after HMA therapy fails, and the single-arm trials that dominate the setting have had no contemporary survival benchmark to be measured against. A Faron-led systematic review and meta-analysis, conducted with investigators from Yale, MD Anderson, King’s College Hospital, The Christie, Moffitt, City of Hope, the University of North Carolina and Helsinki University Hospital, establishes one. Drawing on 61 cohorts and 5,034 patients published over 20 years, the review finds that survival expectations depend heavily on how strictly a trial defines its population. Pooled median OS was 6.68 months across arms enrolling exclusively higher-risk MDS patients, and only 8.54 months even when higher-risk MDS patients accounted for less than 90% of the study population. In the only randomized controlled trial control arm identified, median OS was 5.90 months. Taken together, these figures underline the severity of disease after HMA failure, and how little outcomes have shifted over two decades of investigational studies.

The analysis also found that ORR and CR rate were significantly associated with longer median survival, with each one-percentage-point increase in CR rate corresponding to a 3.4% increase in median OS.

Translational and biomarker findings

Bone marrow immune profiling from 31 BEXMAB MDS patients identified changes that accompany clinical response and baseline features that precede it. In responding patients, erythroid cells expanded after one treatment cycle (median increase 38.9%, P=0.022) and basophil-lineage cells after three cycles (median increase 87.8%, P=0.026), while granulocyte-monocyte progenitor-like cells, monocytes and total Clever-1 positive cells all declined, consistent with a shift away from myeloid-biased hematopoiesis.

Baseline T-cell composition was strongly associated with complete remission in treatment-naïve patients. Complete responders had higher frequencies of CD4+ central memory T-cells (median 38.6% vs 23.6%, P=0.03) and CCR7+ CD8+ T-cells (median 68.9% vs 15.4%, P=0.0055), and lower frequencies of terminally differentiated CD8+ TEMRA cells (median 16.4% vs 44.8%, P=0.045). These findings suggest that pre-existing immune fitness influences response and may support biomarker-driven patient selection. These analyses will be supplemented at the meeting with single-cell RNA sequencing in a larger MDS patient set.

Another role for Clever-1 in hematopoietic regeneration

A non-clinical abstract from Faron’s collaboration with the University of Turku identifies Clever-1 as a previously unrecognized checkpoint on hematopoietic stem and progenitor cells, restraining the bone marrow’s own capacity to regenerate. Clever-1 was expressed on a subset of human CD34+ hematopoietic stem and progenitor cells enriched for self-renewal programs, and its expression was induced by inflammatory stimulation. Genetic deletion or antibody blockade released this restraint, promoting stem cell activation and megakaryopoiesis and accelerating recovery across independent models of hematopoietic injury.

The finding points to a further dimension of Clever-1 biology. Alongside the immune activation and blast-level effects Faron has described previously, Clever-1 blockade may also support the recovery of healthy blood cell production, relevant to diseases such as HR-MDS where failing hematopoiesis is itself a defining feature.

“We have spent years describing what Clever-1 does to the immune system. These data show it is doing even more, acting as a brake on the bone marrow’s own capacity to regenerate. Releasing that brake alongside reprogramming macrophages gives a coherent explanation for what we observe in patients, where responses are accompanied by recovery of healthy blood cell production rather than further suppression of it,” said Maija Hollmén, PhD, Chief Scientific Officer of Faron.

BEXERA Phase 2b trial in progress

The fifth abstract describes the design of BEXERA (NCT07672769), a multicenter, multinational, randomized, double-blind, placebo-controlled Phase 2b trial of bexmarilimab plus azacitidine in treatment-naïve HR-MDS. Approximately 90 participants will be enrolled at approximately 35 sites across North America and Europe and randomized 1:1:1 to bexmarilimab 1 mg/kg, bexmarilimab 3 mg/kg or placebo, each combined with azacitidine. The trial is designed to select the recommended dose for subsequent development using a prospectively defined risk-benefit utility score that integrates efficacy and safety, reviewed by an independent data monitoring committee.

To Faron’s knowledge, BEXERA is the first randomized HR-MDS trial to prospectively combine IPSS-M-defined eligibility and stratification with IWG 2023 response assessment, design choices intended to produce a clearer signal than earlier trials in this setting have achieved.

Abstract details

Abstract 2086. Bexmarilimab combined with azacitidine in higher-risk MDS: Overall survival results of the BEXMAB Phase 1/2 study
Presenting author: Mika Kontro
Session: 637. Myelodysplastic Syndromes: Clinical and Epidemiological: Poster I
Date/time: 12 December 2026, 5:30–7:30 PM CT

Abstract 6357. Overall survival after hypomethylating agent failure in higher-risk myelodysplastic syndromes: A systematic review and meta-analysis
Presenting author: Joab Williamson
Session: 908. Outcomes Research: Myeloid Malignancies: Poster III
Date/time: 14 December 2026, 6:00–8:00 PM CT

Abstract 2061. Baseline T-cell states and hematopoietic remodeling predict response to bexmarilimab plus azacitidine in high-risk myelodysplastic syndromes
Presenting author: Jesper Mickos
Session: 636. Myelodysplastic Syndromes: Basic and Translational: Poster I
Date/time: 12 December 2026, 5:30–7:30 PM CT

Abstract 1354. Clever-1 is a previously unrecognized checkpoint of hematopoietic stem cell regeneration
Presenting author: Sina Tadayon, University of Turku
Session: 501. Hematopoietic Stem and Progenitor Cells and Hematopoiesis: Basic and Translational: Poster I
Date/time: 12 December 2026, 5:30–7:30 PM CT

Abstract 5610. Trial in progress: BEXERA, a randomized, double-blind, placebo-controlled Phase 2b study of bexmarilimab plus azacitidine in treatment-naïve higher-risk myelodysplastic syndromes
Presenting author: Amer M. Zeidan
Session: 637. Myelodysplastic Syndromes: Clinical and Epidemiological: Poster III
Date/time: 14 December 2026, 6:00–8:00 PM CT

All five abstracts are poster presentations and are available at https://www.hematology.org/Meetings/Annual-Meeting/Abstracts

About BEXMAB

The BEXMAB study is an open-label Phase 1/2 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 BEXERA

BEXERA (NCT07672769) is a randomized, double-blind, placebo-controlled Phase 2b clinical trial evaluating bexmarilimab in combination with standard-of-care azacitidine in treatment-naïve patients with higher-risk MDS. The trial is designed to evaluate the efficacy and safety of the combination and select a dose for Phase 3 development. Approximately 90 participants are expected to be enrolled across the United Kingdom, the United States and continental Europe. Patients will receive bexmarilimab at either 1 mg/kg or 3 mg/kg in combination with azacitidine or placebo plus azacitidine.

About bexmarilimab

Bexmarilimab is Faron’s proprietary, investigational immunotherapy designed to overcome resistance to existing treatments and optimize clinical outcomes by targeting myeloid cell function. It binds to Clever-1, a receptor on immunosuppressive macrophages that helps cancer evade the immune system. By targeting Clever-1, bexmarilimab reprograms the tumor microenvironment to ignite a potent anti-tumor immune response.

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 1/2 clinical trials as a potential therapy for patients with hematological cancers and solid tumors in combination with other standard treatments. Further information is available at www.faron.com.

Forward-Looking Statements

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