Clevegen (bexmarilimab) / Faron Pharma - LARVOL DELTA

Macrophage reprogrammer Bexmarilimab Plus Azacitidine in Myelodysplastic Syndrome: PK/PD and biomarker results from the Phase 1/2 BEXMAB Study (ESMO 2025) - No abstract available

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

Secreted Clever-1 modulates T cell responses and impacts cancer immunotherapy efficacy. (PubMed, Theranostics) - P1/2 | "The humanized anti-Clever-1 IgG4 antibody, bexmarilimab, is under clinical investigation for treating solid tumors (NCT03733990) and hematological malignancies (NCT05428969)... These findings identify sClever-1 as a previously unrecognized, immunosuppressive mediator in cancer that operates independently of cellular Clever-1 expression. sClever-1 may serve as both a therapeutic target and biomarker to guide immunotherapy strategies."

IO biomarker • Journal • Breast Cancer • Hematological Disorders • Hematological Malignancies • Oncology • Solid Tumor • CD4 • CD8 • IFNG • TGFB1

FARON ANNOUNCES ACCEPTANCE OF BEXMARILIMAB DATA FOR ORAL PRESENTATION AT ESMO 2025 (Faron Press Release) - "Faron Pharmaceuticals Ltd...announces that new clinical and translational data from the Phase I/II BEXMAB study evaluating bexmarilimab in combination with azacitidine in higher-risk myelodysplastic syndromes (HR-MDS) will be presented as a part of a Mini Oral Abstract Session at the 2025 European Society for Medical Oncology (ESMO) Congress, taking place from October 17-21, 2025, in Berlin, Germany. The oral presentation...will feature the first full disclosure of pharmacokinetic (PK) and pharmacodynamic (PD) data from the BEXMAB study. These results will be presented alongside promising efficacy and biomarker findings, which indicate bexmarilimab’s potential to address a significant unmet need in HR-MDS, a condition with a poor prognosis."

P1/2 data • PK/PD data • Myelodysplastic Syndrome

Faron Pharmaceuticals To Earn Spotlight At IUIS 2025 With Its Bexmarilimab Data (International Business Times) - "The clinical-stage biopharmaceutical company has announced that detailed Phase II data from its BEXMAB study evaluating bexmarilimab (bex), a novel immunotherapy targeting Clever-1, has been accepted for oral presentation at the 19th International Congress of Immunology (IUIS) in Vienna, Austria, from August 17 to 22, 2025...The talk will highlight both frontline HR-MDS patients and those with relapsed/refractory (r/r) disease who have failed prior HMA therapy....According to early disclosures, the data set includes impressive objective response rates and significant reductions in bone marrow blast counts, especially notable in a population where few therapeutic options remain."

P2 data • Myelodysplastic Syndrome

Faron-supported research in Theranostics identifies secreted Clever-1 (sClever-1) as an independent driver of immune evasion in cancer, deepening the understanding of bexmarilimab’s mode of action (Faron Press Release) - "In this study, researchers analyzed plasma samples from breast cancer patients (n=139) and bexmarilimab-treated clinical trial participants (n=193) as well as healthy donors and discovered that a secreted form of Clever-1 or sClever-1 was significantly enriched in the plasma of cancer patients compared to healthy individuals. sClever-1, released by macrophages and endothelial cells, was found to bind to activated T cells, impairing their signaling and promoting the differentiation of suppressive T cells, contributing to tumor immune evasion. Moreover, high sClever-1 levels were associated with resistance to anti-PD-1 therapy. Importantly, the study demonstrated that bexmarilimab treatment significantly reduced the release of sClever-1 in cancer patients. This reduction in circulating sClever-1 correlated with decreased engagement on T cells, providing a direct mechanistic link to the peripheral T-cell activation previously observed in bexmarilimab-treated patients."

Clinical data • Breast Cancer

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

SINGLE-CELL TRANSCRIPTOMICS REVEALS BONE MARROW CHANGES IN MDS PATIENTS RESPONDING TO BEXMARILIMAB AND AZACYTIDINE (EHA 2025) - P1/2 | "Our results highlight a dual mechanism of action for bexmarilimab in MDS, combining blast depletion with immune activation. This study provides mechanistic insights that could aid in refining response prediction and optimizing future therapeutic strategies in myeloid malignancies."

Clinical • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology • Solid Tumor • AVEN • CD8 • GATA1 • GATA2

THERAPEUTIC TARGETING OF MYELOID CELL CHECKPOINT CLEVER-1 INDUCES ANTI-LEUKEMIA EFFECTS IN MYELOID MALIGNANCIES (EHA 2025) - P1/2 | "This study provides novel insights into the role of Clever-1 in AML pathophysiology and the immunomodulatory effects of Bexmarilimab. The results suggest that targeting Clever-1 not only disrupts energy metabolism but also enhances oxidative stress in leukemia blasts, potentially leading to reduced proliferative capacity and increased susceptibility of leukemic stem cells to immunogenic cell death. The findings support the therapeutic potential of Bexmarilimab in myeloid malignancies and lay the groundwork for further clinical evaluation, including ongoing phase I/II trial BEXMAB (NCT05428969) assessing safety and efficacy of Bexmarilimab in combination with Azacytidine on CMML, MDS, and AML patients."

IO biomarker • Acute Myelogenous Leukemia • Chronic Myelomonocytic Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology • Solid Tumor

Faron Pharmaceuticals presents updated Phase II data from BEXMAB Study at EHA 2025 (Faron Press Release) - P1/2 | N=181 | BEXMAB (NCT05428969) | Sponsor: Faron Pharmaceuticals Ltd | "Faron Pharmaceuticals Ltd...presents detailed phase II data from its ongoing BEXMAB study evaluating bexmarilimab in high-risk myelodysplastic syndromes (HR-MDS) as an oral presentation at the 30th European Hematology Association’s (EHA) Congress, taking place in Milan from 12–15 June 2025....With 80% of patients with r/r HR-MDS (n=32) falling in the very high/high risk category at baseline, the phase II BEXMAB data demonstrated an estimated median overall survival (mOS) of approximately 13.4 months, significantly surpassing historical outcomes of 5-6 months expected under standard of care. A mOS of 9.3 months was observed in patients with the aggressive mTP53 mutation (n=13). Five patients in the r/r HR-MDS group proceeded to stem cell transplant (SCT), the only curative option. Of the non-mTP53 mutated patients mOS has not yet been reached and 15 out of 19 patients are still alive."

P2 data • Myelodysplastic Syndrome

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

BEXMAB: A Study to Assess Safety, Tolerability and Preliminary Efficacy of Bexmarilimab in Combination With Standard of Care in Patients With Hematological Malignancies (clinicaltrials.gov) - P1/2 | N=181 | Active, not recruiting | Sponsor: Faron Pharmaceuticals Ltd | Recruiting ➔ Active, not recruiting | Trial completion date: Dec 2025 ➔ Apr 2026 | Trial primary completion date: Apr 2025 ➔ Apr 2026

Enrollment closed • Trial completion date • Trial primary completion date • Acute Myelogenous Leukemia • Chronic Myelomonocytic Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

Faron Pharmaceuticals presents Phase II data from BEXMAB Study at ASCO 2025 (Faron Press Release) - 1/2 | N=181 | BEXMAB (NCT05428969) | Sponsor: Faron Pharmaceuticals Ltd | "The combination of bexmarilimab and azacitidine demonstrated significant efficacy in patients with r/r MDS with a high objective response rate (ORR) of 63%. For the past 20 years re-challenging with an HMA after HMA failure would result in an ORR of 0-15% per the IWG 2006 criteria. Similarly, an ORR of 72% was observed in patients with treatment naïve HR-MDS per the International Working Group (IWG) 2006 criteria. As per the new IWG 2023 criteria, the composite CR (cCR) rate in frontline HR-MDS was 56%, while historically up to 20-25% can be expected with azacitidine alone. This supports moving on to a confirmatory registrational frontline HR-MDS trial comparing bexmarilimab + azacitidine against placebo + azacitidine according to previously received guidance from the FDA."

P2 data • Myelodysplastic Syndrome

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

Faron announces publication of full Phase I BEXMAB study data in Lancet Haematology (Faron Press Release) - P1/2 | N=181 | BEXMAB (NCT05428969) | Sponsor: Faron Pharmaceuticals Ltd | "Faron Pharmaceuticals Ltd...announced the publication of the results of its Phase I BEXMAB study in the prestigious Lancet Haematology which reinforced the safety and efficacy of the treatment in patients with high-risk myelodysplastic syndrome (HR-MDS) and relapsed/refractory (r/r) acute myeloid leukemia (AML)....Among the patients studied in BEXMAB, the estimated median overall survival (mOS) was 8.1 months in patients with r/r AML, and 13.4 months in patients with HMA-failed MDS. Generally, in these relapsed or refractory patients’ remissions are rare and median overall survival is only 5-6 months. The mOS of 13.4 months for patients with HMA-failed MDS is notable and this indication was advanced into Phase 2. Moreover, two HMA-failed MDS patients received a hematopoietic stem cell transplantation (HSCT)."

P1/2 data • Acute Myelogenous Leukemia • Myelodysplastic Syndrome

Faron’s Bexmarilimab demonstrates immune-activating and drug-sensitizing potential in myeloid malignancies (Faron Press Release) - "The study, conducted in collaboration with leading Finnish and Danish academic research centers, examined AML cell lines and bone marrow samples from patients with AML (n = 34) and MDS (n = 4) and showed that CLEVER-1 is highly expressed on malignant myeloid cells, especially in AML with monocytic differentiation....Bexmarilimab monotherapy increased the expression of antigen-presenting HLA-DR by 1.2- to 2-fold in up to 66% of patient samples, especially in those with low baseline expression and high CLEVER-1 levels, without any cytotoxic effects on the blast cells, via potentially inducing interferon gamma (IFNg). Addition of bexmarilimab helped overcome venetoclax-resistance in 33–40% of ex vivo AML samples, without adding to lymphocyte toxicity."

Preclinical • Acute Myelogenous Leukemia • Myelodysplastic Syndrome

Faron announces new data that highlight patient populations with cancer that are most likely to benefit from first-in-class immunotherapy bexmarilimab (Faron Press Release) - "Bexmarilimab stimulated response in immunologically 'cold' tumors (low inflammation) and reduced inflammation in TMEs with strong IFN signaling and advanced TAM activity. The analysis validated five genes (including CXCL9, FCGR1A, GBP5, SLAMF7, and SERPING1) that accurately predicted sensitivity to bexmarilimab. This allows for a potential biomarker-based strategy to enrich patient populations in clinical trials in solid tumors and optimize therapeutic outcomes. A new patent application has been filed for using this method for patient selection."

Patent • Preclinical • Breast Cancer

Finnish researchers uncover how to optimize bexmarilimab use in cancer care (News-Medical) - "Researchers at the University of Turku, Finland, have taken a step towards more personalized and effective cancer treatments. A new study has identified the conditions under which the antibody drug bexmarilimab can activate the body's own defense system against cancer, and how to identify patients who will benefit from the drug. Bexmarilimab has the ability to 'wake up' macrophages, a type of immune cell, to act against cancer. The study found that this activation occurs especially when the tumor microenvironment is immunologically silent. Moreover, in the healthy tissue adjacent to the tumor, bexmarilimab was shown to trigger B cell-mediated immune responses, regardless of how sensitive the neighboring tumor was to the treatment. This suggests that the drug may have immunological effects beyond the tumor itself."

Preclinical • Solid Tumor

Macrophage sensitivity to bexmarilimab-induced reprogramming is shaped by the tumor microenvironment. (PubMed, J Immunother Cancer) - "These findings reveal the complexity of TAM targeting in cancer and emphasize the need for patient selection to maximize bexmarilimab's efficacy."

Biomarker • Journal • Breast Cancer • Oncology • Solid Tumor

CLEVER-1 targeting antibody, bexmarilimab, supports HLA-DR expression and alters ex vivo responsiveness to azacitidine and venetoclax in myeloid malignancies. (PubMed, Sci Rep) - P1/2 | "Our non-clinical findings support the feasibility of CLEVER-1 inhibition in AML/MDS to induce antigen presentating molecule expression and potentially, an anti-leukemic effect together with SoC. Therapeutic targeting of CLEVER-1 with bexmarilimab is currently undergoing clinical investigation in the BEXMAB trial (NCT05428969)."

Journal • Preclinical • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology • Solid Tumor

Macrophage sensitivity to bexmarilimab-induced reprogramming is shaped by the tumor microenvironment (J Immunother Cancer) - "The inflammatory state of the TME emerged as the primary determinant of response. Immune activation occurred in immunologically cold TMEs lacking late-stage activated TAMs, whereas interferon-regulated TMEs exhibited suppressed inflammation. In cancer-free breast tissue, bexmarilimab activated B cell responses independent of treatment sensitivity in the adjacent tumor."

Preclinical • Breast Cancer

Faron Announces Acceptance of Bexmarilimab Data for Oral Presentation at EHA 2025 Congress (Faron Press Release) - "Faron Pharmaceuticals Ltd...announced that data from its ongoing BEXMAB study evaluating bexmarilimab in patients with high-risk myelodysplastic syndromes (HR-MDS) have been accepted for an oral presentation at the 30th European Hematology Association’s (EHA 2025) Congress, taking place in Milan from June 12–15, 2025....The oral presentation will feature detailed efficacy and safety results from the study of bexmarilimab in combination with standard-of-care (azacitidine) in frontline with HR-MDS and those with refractory or relapsed HR-MDS who have failed hypomethylating agent (HMA) therapies (r/r MDS)."

P1/2 data • Myelodysplastic Syndrome

PRELIMINARY EFFICACY OF BEXMARILIMAB WITH AZACITIDINE IN RELAPSED OR REFRACTORY MDS IN BEXMAB PH1/2 STUDY (MDS 2025) - P1/2 | "Complete remission (CR) rate was 5% (1/20) per IWG2006 criteria and CR+CRL rate was 20% (4/20) per IWG2023 criteria. Further updated efficacy parameters including duration of treatment and transfusion independence, will be reported at the meeting, together with updated BM Clever-1 expression biomarker data.ConclusionsBexmarilimab plus azacitidine is well tolerated and results in promising clinical efficacy in r/r MDS patients after HMA failure."

Clinical • Hematological Malignancies • Myelodysplastic Syndrome • Oncology • TP53

Faron Pharmaceuticals presents promising Phase 1/2 data from BEXMAB Study at MDS 2025 plenary session (Faron Press Release) - P1/2 | N=181 | BEXMAB (NCT05428969) | Sponsor: Faron Pharmaceuticals Ltd | "Faron Pharmaceuticals Ltd...presented updated data from its ongoing BEXMAB Phase 1/2 trial at plenary oral session at the 18th International Congress on Myelodysplastic Syndromes (MDS 2025) on May 10, 2025, in Rotterdam, Netherlands....90% of the patients were very high/high risk at baseline and 50% had tp53 mutations. These patients represent a population with extremely limited treatment options and aggressive and difficult-to-treat disease. The BEXMAB Phase 1 & 2 MDS patients with prior HMA failure experienced an estimated median overall survival (mOS) of approximately 13.4 months, compared to the 5-6 months that would typically be expected under standard of care historically."

P1/2 data • Myelodysplastic Syndrome

Faron announces acceptance of bexmarilimab Phase II data for oral presentation at ASCO 2025 (Faron Press Release) - "Faron Pharmaceuticals Ltd...announces that new Phase II data from its ongoing BEXMAB study evaluating bexmarilimab in high-risk myelodysplastic syndromes (HR-MDS) will be presented as a part of a Rapid Oral Abstract Session at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place from 30 May to 3 June 2025, in Chicago, Illinois, USA....The abstract, selected for oral communication, highlights the efficacy and tolerability of bexmarilimab, Faron’s novel humanized anti-Clever-1 antibody, with no dose-limiting toxicities during dose escalation, when used in combination with standard-of-care, azacitidine, treatment in patients with both treatment naïve (frontline) and relapsed/refractory (r/r) HR MDS patients."

P2 data • Myelodysplastic Syndrome

Inside Information: Faron Announces Positive Phase II results in higher-risk myelodysplastic syndrome (Faron Press Release) - P1/2 | N=181 | BEXMAB (NCT05428969) | Sponsor: Faron Pharmaceuticals Ltd | "Faron Pharmaceuticals Ltd...announced positive topline results of the BEXMAB trial, which shows a high overall response rate (ORR) among both frontline as well as relapsed/refractory (r/r) HR MDS patients treated with a combination of bexmarilimab and azacitidine...According to this first fully enrolled Phase II analysis, the treatment continues to be well tolerated without any dose-limiting toxicity in r/r HR MDS patients with no other currently effective treatment options. A high objective response rate of 63% was observed in this initial data cut. The median overall survival remains at the same level as previously reported. Among treatment naïve (frontline phase 1) HR MDS patients, an ORR of 76% was observed...Faron is planning for a Phase III trial, pending U.S Food and Drug Administration (FDA) End of Phase II meeting Feedback"

New P3 trial • P2 data • Myelodysplastic Syndrome