Clinical trials
Advancing bexmarilimab from the clinic to patients
Our clinical program is anchored in higher-risk myelodysplastic syndrome (HR-MDS), a life-threatening form of blood cancer, where survival has not meaningfully improved in over two decades, with an expanding portfolio of investigator-initiated trials testing bexmarilimab across solid tumors and hematological malignancies.
BEXERA — advancing bexmarilimab into a randomized trial in frontline HR-MDS
BEXERA is our priority clinical trial: a randomized, double-blind, placebo-controlled Phase 2b trial of bexmarilimab in treatment-naïve patients with HR-MDS
- Objective: select the recommended Phase 3 dose and generate randomized efficacy and safety data to support later registrational filings in frontline HR-MDS
- Design: bexmarilimab at 1 mg/kg or 3 mg/kg in combination with standard-of-care azacitidine compared with placebo plus azacitidine
- Population: 90 participants across sites in North America and Europe
- Timing: first patient targeted for Q4 2026
In April 2026, Faron entered a strategic collaboration with Parexel International, a leading global clinical research organization with deep hematology-oncology expertise, to support disciplined execution of BEXERA. The trial design reflects direct feedback from an End-of-Phase 2 meeting with the US FDA, which supported an adaptive, randomized approach with dose optimization.
BEXMAB — the Phase 1/2 foundation
BEXMAB is Faron’s open-label Phase 1/2 trial investigating bexmarilimab in combination with standard-of-care azacitidine, in both relapsed/refractory (r/r) and treatment-naïve HR-MDS, as well as in acute myeloid leukemia (AML).
The headline result: in treatment-naïve HR-MDS, patients treated with bexmarilimab plus azacitidine achieved an 85% overall response rate, with a median duration of complete remission of 16.1 months and full clearance of bone marrow blasts in 60% of patients.
BEXMAB completed patient enrolment in November 2025. Clinical and translational analyses have been presented at ASCO, EHA, ESMO, and ASH in 2025, and most recently at EHA 2026, where new translational data described how bexmarilimab reshapes the immune environment of the bone marrow. Findings have also included deep, durable responses that allowed a meaningful proportion of patients to proceed to stem cell transplant, and restoration of transfusion independence in patients who were transfusion-dependent at baseline. Further findings from BEXMAB will be presented at ASH 2026.
Regulatory recognition for bexmarilimab in HR-MDS:
| Designation | Granted by | Date |
|---|---|---|
| Fast Track Designation | US FDA | August 2024 |
| Innovation Passport | UK MHRA | December 2024 |
| Orphan Drug Designation | EMA | February 2025 |
| Orphan Drug Designation | US FDA | March 2025 |
Extending bexmarilimab through investigator-initiated trials
Clever-1 is expressed across a range of solid tumors associated with an immunosuppressive, macrophage-rich microenvironment. Working with leading academic and clinical partners, we support a growing portfolio of investigator-initiated trials (IITs) testing bexmarilimab in various combinations and multiple tumor types.
SOLID TUMORS
BLAZE — overcoming resistance to anti-PD-1 therapy
A Phase 1/2 IIT sponsored by the Institute of Cancer Research and conducted at the Royal Marsden (London, UK), evaluating bexmarilimab combined with nivolumab— a combination selected by the trial investigators — in patients with PD-1-resistant metastatic non-small cell lung cancer and melanoma. Patients receive a short course of bexmarilimab priming ahead of the combination, with intensive biomarker sampling to track the macrophage switch driving any reversal of resistance. Around 62 patients are planned across dose escalation and expansion.
BEXAR — turning cold tumors hot in soft-tissue sarcoma
A Phase 1b/2 IIT sponsored by MEDSIR and conducted with University Hospital Vall d’Hebron in Barcelona is evaluating bexmarilimab in combination with standard-of-care doxorubicin in previously untreated metastatic soft-tissue sarcoma. The disease is among the tumor types with the highest Clever-1 expression observed in oncology, yet treatment options have changed little over the past decades. By combining bexmarilimab with chemotherapy, the trial investigates whether reprogramming immunosuppressive macrophages can trigger an anti-tumor immune response and improve patient outcomes. Following Phase 1b dose escalation and expansion, the trial is designed to progress into a randomized Phase 2 portion comparing bexmarilimab plus doxorubicin against doxorubicin alone, with progression-free survival as the primary endpoint.
HEMATOLOGY
BEAM-X — preventing relapse after stem cell transplant in AML
A Phase 2 open-label, single-arm IIT led by the Nordic AML Group and sponsored by Helsinki University Hospital, evaluating bexmarilimab combined with azacitidine in patients with measurable residual disease (MRD)-positive AML following allogeneic stem cell transplantation, when the risk of relapse is highest. The primary endpoint of the trial will be MRD negativity at 6 months after initiation of the bexmarilimab treatment.
MATINS — where the bexmarilimab story began
MATINS was the first-in-human Phase 1/2 trial of bexmarilimab as a single agent, across ten advanced, treatment-resistant solid tumor types. It established the safety profile and provided the first clinical evidence that bexmarilimab drives macrophages to switch from a tumor-supportive to a tumor-fighting state, increasing interferon-gamma signaling in a way that tracked with clinical benefit.
Patients who achieved disease control in MATINS had a median overall survival of 14.9 months, compared with 4.4 months for those who did not — a threefold difference that continues to underpin our rationale for combining bexmarilimab with standard-of-care therapies today.