Clevegen (bexmarilimab) / Faron Pharma - LARVOL DELTA

Efficacy, molecular and translational analysis of TP53-mutated HR-MDS with bexmarilimab and azacitidine: Updated results from the bexmab Phase 1/2 study (ASH 2025) - "ConclusionBexmarilimab plus azacitidine shows encouraging activity in mTP53 HR MDS and translational datasupports potential for altering the immune dysregulation in mTP53 MDS. Updated clinical andtranslational data will be reported."

Clinical • P1/2 data • Hematological Malignancies • Myelodysplastic Syndrome • AVEN • CD8 • TP53

Macrophage reprogrammer bexmarilimab plus azacitidine in myelodysplastic syndrome: PK/PD and biomarker results from the phase I/II BEXMAB study (ESMO 2025) - P1/2 | "In addition to these translational results, full pharmacokinetic (PK) and pharmacodynamic (PD, including correlation with clinical response) data will be presented for the first time. Conclusions Together, the clinical and biological findings highlight bexmarilimab's potential as a novel therapeutic strategy for HR MDS and support its advancement into phase 3."

Biomarker • P1/2 data • PK/PD data • Hematological Malignancies • Myelodysplastic Syndrome • Oncology • AVEN • CD8

Efficacy of macrophage checkpoint Clever-1 inhibition with bexmarilimab plus azacitidine in myelodysplastic syndrome: Results from the ph1/2 BEXMAB study. (ASCO 2025) - P1/2 | "Enrolment for both dose finding and randomized dose optimization parts (n=55) of the BEXMAB Phase 1/2 study has been completed. Safety and efficacy results for both populations will be reported for the first time."

Clinical • Hematological Malignancies • Myelodysplastic Syndrome • Oncology

Bexmarilimab plus azacitidine for high-risk myelodysplastic syndrome and relapsed or refractory acute myeloid leukaemia: results from the dose-escalation part of a multicentre, single-arm, phase 1/2 trial. (PubMed, Lancet Haematol) - P1/2 | "Bexmarilimab in combination with azacitidine has a manageable safety profile, consistent with azacitidine, and shows promising clinical activity in patients with high-risk myelodysplastic syndrome."

Journal • P1/2 data • Acute Myelogenous Leukemia • Chronic Myelomonocytic Leukemia • Febrile Neutropenia • Hematological Disorders • Hematological Malignancies • Hemophagocytic lymphohistiocytosis • Immunology • Infectious Disease • Leukemia • Myelodysplastic Syndrome • Neutropenia • Oncology • Pneumonia • Rare Diseases • Respiratory Diseases • Septic Shock • Thrombocytopenia

BEXAR: A PHASE IB/II STUDY TO EVALUATE SAFETY AND EFFICACY OF BEXMARILIMAB IN COMBINATION WITH DOXORUBICIN IN METASTATIC SOFT-TISSUE SARCOMA (clinicaltrials.gov) - P1/2 | N=278 | Not yet recruiting | Sponsor: MedSIR

New P1/2 trial • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

Transfusion independence, hematological improvement and associated safety outcomes with bexmarilimab and azacitidine in HR-MDS: Results of the bexmab Phase 1/2 study (ASH 2025) - "In addition, pre-clinical datafrom Clever-1 knock-out and anti-Clever-1 treated mice suggests improved hematopoiesis andhematological recovery after 5-fluorouracil based chemotherapy. Altogetherthese data suggest that Clever-1 inhibition with the bexmarilimab combination enables hematopoieticrecovery in MDS patients. ConclusionMaintenance of baseline TI status, increased TI rate and increased number of BM progenitor cellsproducing platelets and RBCs, support bexmarilimab's unique mechanism of action in HR MDS,improving the efficacy of HMAs and supporting hematopoietic recovery, associated with lower rate ofadverse events."

Clinical • P1/2 data • Leukopenia • Myelodysplastic Syndrome • Neutropenia • AVEN

Clever-1 blockade as a potential immunomodulatory treatment for brain tumors. (ITOC 2026) - "These responders exhibited low IFN signalling at baseline while Bexmarilimab induced pro-inflammatory immune responses implying enhanced antigen-presentation, upregulated IFN-γ, IFN-α and TNF-α signalling and downregulated M2 macrophage signature. Conclusion Our findings support Bexmarilimab as a promising treatment to induce antitumor responses by reprogramming immunosuppressive macrophages in pediatric and adult brain tumors and provide a means to predict the efficacy of Bexmarilimab using patient-derived tumor tissues."

Immunomodulating • Astrocytoma • Brain Cancer • Glioblastoma • Glioma • Medulloblastoma • Meningioma • Oligodendroglioma • Oncology • Rhabdoid Tumor • Sarcoma • Solid Tumor • Squamous Cell Carcinoma • AVEN • IFNA1 • IFNG • TNFA

Faron and City of Hope in Process of Developing a Phase II Investigator-Initiated Trial of Bexmarilimab in Relapsed/Refractory MDS (ACCESS Newswire) - "Faron Pharmaceuticals Ltd...announces that investigators at City of Hope, one of the largest and most advanced cancer research and treatment organizations in the United States, are in the process of developing a Phase II investigator-initiated clinical trial (IIT) in collaboration with Faron to evaluate bexmarilimab in participants with relapsed or refractory myelodysplastic syndrome (r/r MDS)...The proposed open-label IIT is being designed by hematology investigators at City of Hope who are participating in Faron's ongoing Phase I/II BEXMAB trial...Enrollment of the first participant is expected in the second half of 2026."

New P2 trial • Myelodysplastic Syndrome

Faron Pharmaceuticals Ltd…announces that data from its Phase I/II BEXMAB trial evaluating bexmarilimab in combination with azacitidine for the treatment of higher-risk myelodysplastic syndromes (MDS) have been accepted for presentation at the 66th Annual Scientific Meeting of the British Society for Haematology (BSH), taking place 19–21 April 2026 in Liverpool, UK. (Faron Press Release) - "The poster presents the full dataset included in the accepted abstract based on the 3 November 2025 data cut (55 patients: 21 treatment‑naïve; 34 HMA‑refractory/relapsed). The results support the planned advancement of bexmarilimab into the next development phase in treatment‑naïve higher‑risk MDS."

P1/2 data • Myelodysplastic Syndrome

Faron Pharmaceuticals Ltd….announces a significant expansion of its clinical development program with the upcoming initiation of the Phase II BEAM-X Investigator-Initiated Trial (IIT) led by the Nordic AML Group with Dr. Mika Kontro serving as principal investigator. (Faron Press Release) - "The trial evaluates bexmarilimab in combination with azacitidine for patients with measurable residual disease (MRD) positive acute myeloid leukemia (AML) following allogeneic stem cell transplantation....First patient in is expected in Q3 2026, with the initial stage-1 efficacy readout anticipated 12–15 months after enrolment begins."

New P2 trial • P2 data • Acute Myelogenous Leukemia

Faron plans €40m rights issue to fund bexmarilimab through key cancer trial milestones (TipRanks) - "Funds will support an FDA-agreed Phase II/III MDS trial and multiple cancer studies, aligning with new guidelines to shorten development, cut costs, and bolster partnering prospects."

Financing • New P2/3 trial • Myelodysplastic Syndrome

New review published in Immunotherapy highlights the potential for Clever-1 inhibition with bexmarilimab to become the cornerstone of next-generation, multi-indication cancer immunotherapy (Faron Press Release) - "The article offers a detailed exploration into the role of Clever-1 as a master regulator of immune suppression, providing a detailed mechanistic blueprint of how bexmarilimab functions....Beyond the science, it provides a comprehensive clinical synthesis of Faron’s journey with bexmarilimab to date, integrating pivotal longitudinal data from the MATINS trial in late-stage solid tumors and the BEXMAB trial in hematological malignancies. These findings illustrate a consistent safety profile and significant clinical activity across diverse and difficult-to-treat indications, underscoring the universal nature of Clever-1 as a myeloid checkpoint."

Clinical data • Acute Myelogenous Leukemia • Chronic Myelomonocytic Leukemia • Myelodysplastic Syndrome • Solid Tumor

Clinical optimization of bexmarilimab as a myeloid checkpoint therapy. (PubMed, Immunotherapy) - "This review summarizes the biological rationale for Clever-1 targeting, appraises clinical and translational evidence, and outlines strategies to enhance therapeutic efficacy through patient selection, rational drug combinations, biomarker-driven patient stratification, and timing of intervention. We also highlight future opportunities for integrating bexmarilimab with next-generation immunotherapies and precision medicine approaches."

IO biomarker • Journal • Review • Acute Myelogenous Leukemia • Oncology

Faron Expands Bexmarilimab Program in Solid Tumors with a Randomized Phase I/II BEXAR IIT in Metastatic Soft-Tissue Sarcoma (ACCESS Newswire) - "Study conducted in a collaboration between MEDSIR and University Hospital Vall d'Hebron to evaluate bexmarilimab plus standard-of-care doxorubicin in a high-unmet-need frontline setting....Faron continues to leverage its deep understanding of the Clever-1 pathway to address solid tumors."

Commercial • Trial status • Soft Tissue Sarcoma

EFFICACY OF MACROPHAGE CHECKPOINT CLEVER-1 INHIBITION WITH BEXMARILIMAB PLUS AZACITIDINE IN MYELODYSPLASTIC SYNDROME: RESULTS FROM THE PH1/2 BEXMAB STUDY (EHA 2025) - "Enrolment for both dose finding and randomized dose optimization parts (n=55) of the BEXMAB Phase 1/2 study has been completed. Safety and efficacy results for both frontline and r/r MDS populations will be reported."

Clinical • Hematological Malignancies • Myelodysplastic Syndrome • Oncology

Faron announces strategic collaboration with The Institute for Cancer Research to launch BLAZE trial, targeting immunotherapy resistance in cancer (Faron Press Release) - "The Phase I/II BLAZE trial will investigate Faron’s lead asset, bexmarilimab, in combination with the anti-PD-1 checkpoint inhibitor, zimberelimab provided by Gilead Sciences, for patients with metastatic non-small cell lung cancer (NSCLC) and melanoma who have developed resistance to prior anti-PD-1-based immunotherapy and progressed within three months of the last anti-PD-1 treatment."

Commercial • Melanoma • Non Small Cell Lung Cancer

Faron presents updated BEXMAB data at ASH 2025: Deep and durable responses in HR-MDS with favorable safety profile (Faron Press Release) - "In treatment-naïve HR-MDS, the bexmarilimab and azacitidine combination reported an overall response rate (ORR) of 85% and a complete remission (CR) rate of 45%. Efficacy was exceptionally strong in patients with TP53 mutations, who achieved an ORR of 80% and a CR rate of 70% (50% of this TP53 cohort proceeded to stem cell transplant). Overall, 55% of treatment-naïve patients showed complete clearance of bone marrow blasts, and 35% proceeded to stem cell transplant (SCT)."

P1/2 data • Myelodysplastic Syndrome

CLEVER-1 blockade reprograms TAMs to overcome anti-PD-1 resistance in gastric cancer. (PubMed, J Immunother Cancer) - "These findings identify CLEVER-1+ TAMs as both biomarker and functional mediator of anti-PD-1 therapy resistance, providing a rationale for combining bexmarilimab with immune checkpoint blockade in GC. In this commentary, we discuss the mechanistic significance, translational potential, and clinical prospects of CLEVER-1 blockade to overcome immunotherapy resistance in GC."

IO biomarker • Journal • Gastric Cancer • Metabolic Disorders • Oncology • Solid Tumor • AVEN • PPARG

Encouraging Efficacy Observed in Bexmab Study: A Phase 1/2 Study to Assess Safety and Efficacy of Bexmarilimab in Combination with Standard of Care in Myeloid Malignancies (ASH 2023) - P1/2 | "Treatment of AML bone marrow cells with BEX alone or in combination with azacitidine/venetoclax results in enhanced antigen presentation capacity and increased activation markers on effector T cells with synergistic effect on cell death. Additional clinical and pharmacodynamic data of the completed Ph1 of the study will be presented during the meeting. Ph2 of BEX plus azacitidine will open in the 2nd half of 2023 in HMA-failed r/r AML and/or higher risk MDS patients."

Clinical • Combination therapy • P1/2 data • Acute Myelogenous Leukemia • Hematological Malignancies • Hemophagocytic lymphohistiocytosis • Immunology • Leukemia • Myelodysplastic Syndrome • Oncology • Rare Diseases • CD8

Encouraging Efficacy of Bexmarilimab with Azacitidine in Relapsed or Refractory MDS in Bexmab Ph1/2 Study (ASH 2024) - P1/2 | "Preliminary data suggest significant changes in the expression of genes related to blast cell energy production and macrophage activity induced by bexmarilimab and azacitidine treatment. Conclusions Bexmarilimab plus azacitidine is well tolerated and results in promising clinical efficacy in r/r MDS patients after HMA failure."

Clinical • Febrile Neutropenia • Hematological Disorders • Hematological Malignancies • Myelodysplastic Syndrome • Neutropenia • Oncology • CD4 • CD8 • TP53

Correction: Macrophage sensitivity to bexmarilimab-induced reprogramming is shaped by the tumor microenvironment. (PubMed, J Immunother Cancer) - No abstract available

Biomarker • Journal • Oncology

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. (Faron Press Release) - "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."

P1/2 data • P53mut • Myelodysplastic Syndrome

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. (Faron Press Release) - "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."

P1/2 data • Myelodysplastic Syndrome

Faron Pharmaceuticals Ltd…announces the official completion of patient enrolment in its BEXMAB Phase 2 trial. (ACCESS Newswire) - "The formal decision to conclude enrolment was supported by the trial Steering Group...The trial will continue with ongoing patient treatment and follow-up, and a final data update is scheduled for an upcoming major scientific meeting...'We will now focus on conducting the registrational Phase 2/3 trial for bexmarilimab in treatment-naïve patients with HR-MDS'"

Enrollment closed • New P2/3 trial • Myelodysplastic Syndrome

Updated BEXMAB Phase I/II Data presented at ESMO 2025 shows further improvement, strengthening the clinical profile of bexmarilimab in treatment-naïve HR-MDS patients (Faron Press Release) - "Faron will be hosting a virtual webinar to discuss the updated BEXMAB data presented at ESMO 2025 on 23 October at 4pm EEST/9am ET...The updated data presented at ESMO 2025 reinforces the efficacy previously observed for the bexmarilimab and azacitidine combination. In 20 evaluable treatment-naïve patients, the study confirmed an 85% ORR and a 45% CR rate. These high response rates were observed in a difficult-to-treat population, where over 66% of patients were classified as high to very high risk at baseline. The combination also showed robust activity in patients with high-risk mutations like mTP53, achieving an ORR of 78%...In the r/r HMA-failed population (n=32), the combination achieved a 63% ORR and a median overall survival (mOS) of 13.4 months....The most significant update is the new pharmacodynamic data that provided a clear biological explanation for the strong clinical results."

P1/2 data • Myelodysplastic Syndrome