Clevegen (bexmarilimab) / Faron Pharma - LARVOL DELTA

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

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

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, 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

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

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

Activity of bexmarilimab, a novel macrophage checkpoint inhibitor, in PD-1 refractory metastatic melanoma: final results from the phase I/II MATINS study (ESMO 2026) - No abstract available

Checkpoint inhibition • Clinical • Metastases • P1/2 data • Melanoma • Oncology • Solid Tumor

BEXAR: A phase Ib/II study of bexmarilimab plus doxorubicin in metastatic soft tissue sarcoma (STS) (ESMO 2026) - No abstract available

Metastases • P1/2 data • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

Faron Pharmaceuticals Ltd…announces that it will host an R&D Day for investors, analysts and media on 8 October 2026 at 08:00 am (EDT) / 13:00 pm (BST) / 15:00 pm (EEST). (Faron Press Release) - "The event will provide an opportunity for Faron’s senior management team, together with leading external clinical experts, to review progress across the company’s bexmarilimab clinical development program and to discuss the scientific rationale and clinical opportunity across both hematological and solid tumor indications."

Clinical • Hematological Malignancies • Solid Tumor

Clever-1 blockade reprogrammes immunosuppressive macrophages in brain tumor microenvironment (EANO 2026) - P1/2 | "Our results support that targeting Clever-1 can promote anti-tumor response in pediatric and adult brain tumors by reprogramming their myeloid immune landscape and provide a means to predict the efficacy of Bexmarilimab using patient-derived tissues. Future studies could reveal the active role Clever-1 plays in brain TME through microglia and macrophages."

Biomarker • IO biomarker • Tumor microenvironment • Astrocytoma • Brain Cancer • Glioblastoma • Glioma • Hematological Malignancies • Medulloblastoma • Meningioma • Oligodendroglioma • Oncology • Rhabdoid Tumor • Sarcoma • Solid Tumor • Squamous Cell Carcinoma • CD8 • IFNG • TNFA

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 | Recruiting | Sponsor: MedSIR | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

Faron Pharmaceuticals Ltd…announces that the first patient has been enrolled in the Phase 1b/2 BEXAR investigator-initiated trial. (Faron Press Release) - "This enrollment marks the first patient treated with bexmarilimab in the BEXAR trial and the first clinical evaluation of an anti-Clever-1 strategy in combination with doxorubicin in patients with soft-tissue sarcoma."

Enrollment status • Soft Tissue Sarcoma

Faron announced a collaboration with Parexel, a global clinical research organization, to support the randomized Phase 2b BEXERA trial (FP2CLI012) in frontline, treatment-naïve higher-risk (HR) MDS, planned to start in the second half of 2026. (Faron Press Release)

Trial status • Myelodysplastic Syndrome

BLAZE: Investigating the Combination of Bexmarilimab and Nivolumab in Solid Tumours, Melanoma and NSCLC (clinicaltrials.gov) - P1/2 | N=62 | Recruiting | Sponsor: Institute of Cancer Research, United Kingdom | Not yet recruiting ➔ Recruiting

Enrollment open • Cutaneous Melanoma • Genetic Disorders • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Skin Cancer • Solid Tumor • ALK • BRAF • EGFR

Faron Pharmaceuticals Ltd…announced that it has conducted its first overall survival (OS) data cut from treatment-naive higher-risk myelodysplastic syndrome (HR-MDS) patients enrolled in the BEXMAB trial. (Faron Press Release) - "At this time, after a median follow-up of 14.9 months, the only subgroup to have hit the median is the biallelic TP53 mutated population. This subgroup, historically associated with very poor outcomes, achieved a median OS of 8.8 months, which is in line with historical data and reassuring given the complex cytogenetics within the BEXMAB biallelic patient population. Other subgroups: monoallelic TP53 mutated and wildtype patients have still not reached their median OS...Of the 21 treatment-naive HR-MDS patients, 48% harboured TP53 mutations, a well-established adverse prognostic factor associated with inferior survival outcomes. Of the TP53 mutated patients (with known allele frequency data), 33% had monoallelic TP53 alterations, and 67% had biallelic TP53 alterations. Survival follow-up is ongoing, and several patients remain alive and under follow-up, providing the opportunity for further maturation of the dataset over time."

P1/2 data • P53mut • P53WT • Myelodysplastic Syndrome

Stabilin-1+ Tumor Endothelium Organizes a Perivascular Regulatory T-Cell Niche in Renal Cell Carcinoma (KCRS 2026) - "Background Stabilin-1 (STAB-1 / CLEVER-1) is a scavenger receptor on tumor-associated macrophages (TAMs) and tumor endothelium and is the target of the humanized antibody bexmarilimab (MATINS, phase I/II), advanced as a dual agent that re-polarizes TAMs to M1 phenotype and rebalances the T cell populations entering through the vascular gate...These observations support the dual mechanistic rationale for anti-CLEVER-1 therapy in RCC — removal of endothelial STAB-1 would be expected to both re-polarize suppressive TAMs and dismantle the perivascular Treg trap, potentially redistributing the existing tumor-infiltrating lymphocyte pool. Keywords stabilin-1; multiplex immunohistochemistry; tumor microenvironment; regulatory T cell; tumor endotheliu"

Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • CD31 • CD68 • CD8 • CDH5 • FOXP3 • PECAM1 • PTPRC

BLAZE: Investigating the Combination of Bexmarilimab and Nivolumab in Solid Tumours, Melanoma and NSCLC (clinicaltrials.gov) - P1/2 | N=62 | Not yet recruiting | Sponsor: Institute of Cancer Research, United Kingdom

New P1/2 trial • Cutaneous Melanoma • Genetic Disorders • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Skin Cancer • Solid Tumor • ALK • BRAF • EGFR

FINPROVE: Bexmarilimab cohort not to proceed (Faron Press Release) - "The FINPROVE trial is an ongoing national, investigator‑initiated precision medicine study sponsored by Helsinki University Hospital, designed to evaluate targeted treatment approaches across multiple tumor types. Following a regulatory review by the Finnish Medicines Agency (Fimea), the proposed bexmarilimab cohort was considered incompatible with the FINPROVE platform trial, which focuses primarily on marketed therapies with established and approved patient selection strategies. This outcome does not impact Faron’s broader development program for bexmarilimab."

Trial status • Hematological Malignancies • Solid Tumor

BLAZE: Investigators update combination treatment to approved standard-of-care nivolumab (Faron Press Release) - "The investigators of the BLAZE IIT, led by The Institute of Cancer Research (ICR) and conducted at The Royal Marsden NHS Foundation Trust in London, UK, as well as other leading UK hospitals, have updated the trial’s anti-PD-1 combination drug to nivolumab (Opdivo), a fully approved, globally used standard-of-care anti-PD-1 inhibitor. The trial has received the necessary regulatory and ethical approvals and is advancing towards first patient enrolment...The BLAZE trial is a Phase 1/2 evaluating bexmarilimab in combination with nivolumab in patients with metastatic non-small cell lung cancer (NSCLC) or melanoma who have developed resistance to prior anti-PD-1-based immunotherapy."

New P1/2 trial • Melanoma • Non Small Cell Lung Cancer

BEXAR: Regulatory approval received in frontline soft-tissue sarcoma (Faron Press Release) - "The BEXAR trial has received the necessary regulatory and ethical approvals and is advancing towards first patient recruitment. BEXAR is a randomized Phase 1b/2 IIT sponsored by MEDSIR and conducted at six Spanish hospitals and led by Dr. Cesar Serrano at the University Hospital Vall d’Hebron in Barcelona, Spain...The trial evaluates bexmarilimab in combination with standard-of-care doxorubicin in patients with first-line metastatic soft-tissue sarcoma. The expression of bexmarilimab’s target, Clever-1, in soft-tissue sarcomas is among the highest observed across tumor types, providing a strong biological rationale for the use of bexmarilimab in this setting."

New P1/2 trial • Soft Tissue Sarcoma

BEXERA: Bexmarilimab + Azacitidine Versus Placebo + Azacitidine in Participants With Treatment-nave Higher-risk Myelodysplastic Syndromes (clinicaltrials.gov) - P2 | N=90 | Not yet recruiting | Sponsor: Faron Pharmaceuticals Ltd

New P2 trial • Hematological Malignancies • Myelodysplastic Syndrome • Oncology

TRANSLATIONAL INSIGHTS AND CLINICAL EFFICACY WITH BEXMARILIMAB AND AZACITIDINE IN HR-MDS IN THE BEXMAB PHASE 1/2 STUDY (EHA 2026) - P1/2 | "Addition of BEX to AZA results in encouraging clinical efficacy in both treatment-naïve HR-MDS as well as r/r MDS. Translational results for the full study population, including both frontline and r/r MDS, will be reported for the first time."

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

Faron Presents Matured BEXMAB Data at EHA 2026 Confirming Durable Efficacy and Bone Marrow Reprogramming in HR-MDS (Faron Press Release) - "Data continue to demonstrate prolonged durability of response, with median duration of CR reaching 16.1 months in frontline HR-MDS, supporting the upcoming initiation of the Phase 2b trial....Frontline HR-MDS treatment achieved an 85% Overall Response Rate (ORR), with 60% of patients achieving full clearance of bone marrow blasts....Data from the treatment-naïve HR-MDS cohort continues to mature positively, reflecting an ORR of 85% and a CR rate of 45%....Backed by this clear translational validation and strong regulatory alignment, the Company is fully on track to initiate its randomized, placebo-controlled Phase 2b clinical trial (designated as the BEXERA trial) in treatment-naïve higher-risk MDS patients during the second half of 2026."

New P2b trial • P1/2 data • Myelodysplastic Syndrome

MEDOPP0799: A PHASE IB/II STUDY TO EVALUATE SAFETY AND EFFICACY OF BEXMARILIMAB IN COMBINATION WITH DOXORUBICIN IN METASTATIC SOFT-TISSUE SARCOMAn(BEXAR Study) (clinicaltrialsregister.eu) - P1/2 | N=278 | Not yet recruiting | Sponsor: Medica Scientia Innovation Research S.L.

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

Post‑EHA webcast (Faron Press Release) - "Faron will host a live webcast on Monday, 15 June 2026, following the EHA Congress. The webcast will be hosted by Faron management and will feature Dr. Mika Kontro, Principal Investigator of the BEXMAB study and presenting author of Faron’s EHA poster. The webcast will focus on the broader clinical and scientific context of the BEXMAB programme and will include a live Q&A session."

P1/2 data • Myelodysplastic Syndrome