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    DRUG:

    Clevegen (bexmarilimab)

    i
    Other names: FP-1305, FP1305, FP 1305
    Company:
    Faron Pharma
    Drug class:
    STAB1 inhibitor
    1d
    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.
    Journal • PD(L)-1 Biomarker • IO biomarker
    |
    PPARG (Peroxisome Proliferator Activated Receptor Gamma) • AVEN (Apoptosis And Caspase Activation Inhibitor)
    |
    Clevegen (bexmarilimab)
    4ms
    Secreted Clever-1 modulates T cell responses and impacts cancer immunotherapy efficacy. (PubMed, Theranostics)
    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.
    Journal • PD(L)-1 Biomarker • IO biomarker
    |
    CD8 (cluster of differentiation 8) • IFNG (Interferon, gamma) • CD4 (CD4 Molecule) • TGFB1 (Transforming Growth Factor Beta 1)
    |
    Clevegen (bexmarilimab)
    6ms
    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, 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
    |
    Venclexta (venetoclax) • azacitidine • Clevegen (bexmarilimab)
    over1year
    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, Recruiting, Faron Pharmaceuticals Ltd | Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Dec 2024 --> Apr 2025
    Trial completion date • Trial primary completion date • Combination therapy
    |
    Venclexta (venetoclax) • azacitidine • Clevegen (bexmarilimab)
    almost2years
    A Study to Assess Safety, Tolerability and Preliminary Efficacy of Bexmarilimab in Combination With Standard of Care in Patients With Hematological Malignancies (BEXMAB) (clinicaltrials.gov)
    P1/2, N=181, Recruiting, Faron Pharmaceuticals Ltd | Trial primary completion date: Dec 2023 --> Dec 2024
    Trial primary completion date • Combination therapy
    |
    Venclexta (venetoclax) • azacitidine • Clevegen (bexmarilimab)
    almost2years
    Bexmarilimab-induced macrophage activation leads to treatment benefit in solid tumors: The phase I/II first-in-human MATINS trial. (PubMed, Cell Rep Med)
    Spatial transcriptomics profiling of DC and non-DC tumors demonstrates bexmarilimab-induced macrophage activation and stimulation of IFNγ and T cell receptor signaling selectively in DC patients. These data suggest that bexmarilimab therapy is well tolerated and show that macrophage targeting can promote immune activation and tumor control in late-stage cancer.
    P1/2 data • Journal
    |
    ER (Estrogen receptor) • IFNG (Interferon, gamma)
    |
    ER positive
    |
    Clevegen (bexmarilimab)
    2years
    A Study to Evaluate Safety, Tolerability and Preliminary Efficacy of FP-1305 in Cancer Patients (MATINS) (clinicaltrials.gov)
    P1/2, N=216, Completed, Faron Pharmaceuticals Ltd | Active, not recruiting --> Completed | Trial completion date: Nov 2024 --> Oct 2023
    Trial completion • Trial completion date
    |
    PD-L1 (Programmed death ligand 1) • PD-1 (Programmed cell death 1)
    |
    Clevegen (bexmarilimab)
    2years
    Bexmarilimab activates human tumor-associated macrophages to support adaptive immune responses in interferon-poor immune microenvironments. (PubMed, Cancer Immunol Res)
    We further showed that bexmarilimab was most efficacious in macrophages with low baseline IFN signaling, as chronic IFNγ priming abolished bexmarilimab-induced TNFα release. These results highlight an approach to target immunologically cold tumors and to increase the likelihood of their subsequent response to immune checkpoint inhibitors.
    Journal
    |
    IFNG (Interferon, gamma) • TNFA (Tumor Necrosis Factor-Alpha) • CXCL10 (Chemokine (C-X-C motif) ligand 10)
    |
    Clevegen (bexmarilimab)
    2years
    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)
    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 • P1/2 data • Combination therapy
    |
    CD8 (cluster of differentiation 8)
    |
    Venclexta (venetoclax) • azacitidine • Clevegen (bexmarilimab)
    2years
    A Study to Evaluate Safety, Tolerability and Preliminary Efficacy of FP-1305 in Cancer Patients (MATINS) (clinicaltrials.gov)
    P1/2, N=216, Active, not recruiting, Faron Pharmaceuticals Ltd | Trial primary completion date: Nov 2024 --> Sep 2023
    Trial primary completion date • Metastases
    |
    PD-L1 (Programmed death ligand 1) • PD-1 (Programmed cell death 1)
    |
    Clevegen (bexmarilimab)
    over2years
    Full efficacy analysis of phase I/II trial investigating bexmarilimab, a novel macrophage-guided immunotherapy in refractory solid tumors (ESMO 2023)
    Conclusions Bexmarilimab demonstrates promising anti-tumour activity as a monotherapy in several refractory solid tumours. A dose of 1mg/kg Q3W is considered feasible for further monotherapy studies in solid tumors.
    Clinical • P1/2 data
    |
    AVEN (Apoptosis And Caspase Activation Inhibitor)
    |
    Clevegen (bexmarilimab)
    over2years
    Dose Escalation Trial of Bexmarilimab (FP-1305) Plus Pembrolizumab in Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P1, N=0, Withdrawn, The University of Texas Health Science Center at San Antonio | N=36 --> 0 | Not yet recruiting --> Withdrawn
    Enrollment change • Trial withdrawal • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    Keytruda (pembrolizumab) • Clevegen (bexmarilimab)