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DRUG CLASS:

STAB1 inhibitor

9d
New P1/2 trial
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doxorubicin hydrochloride • Clevegen (bexmarilimab)
2ms
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 | Trial completion date: Apr 2026 --> Mar 2027 | Trial primary completion date: Apr 2026 --> Mar 2027
Trial completion date • Trial primary completion date
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Venclexta (venetoclax) • azacitidine • Clevegen (bexmarilimab)
3ms
New P1/2 trial
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doxorubicin hydrochloride • Clevegen (bexmarilimab)
7ms
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
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PPARG (Peroxisome Proliferator Activated Receptor Gamma) • AVEN (Apoptosis And Caspase Activation Inhibitor)
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Clevegen (bexmarilimab)
11ms
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
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CD8 (cluster of differentiation 8) • IFNG (Interferon, gamma) • CD4 (CD4 Molecule) • TGFB1 (Transforming Growth Factor Beta 1)
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Clevegen (bexmarilimab)
1year
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
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Venclexta (venetoclax) • azacitidine • Clevegen (bexmarilimab)
almost2years
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
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Venclexta (venetoclax) • azacitidine • Clevegen (bexmarilimab)
over2years
Deficiency of Stabilin-1 in the Context of Hepatic Melanoma Metastasis. (PubMed, Cancers (Basel))
Hepatic melanoma metastases show resistance to Stabilin-1 targeting approaches. This suggests that anti-Stab1 therapies should be considered with respect to the tumor entity or target organs.
Journal
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POSTN (Periostin)
over2years
Trial primary completion date • Combination therapy
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Venclexta (venetoclax) • azacitidine • Clevegen (bexmarilimab)
over2years
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
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ER (Estrogen receptor) • IFNG (Interferon, gamma)
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ER positive
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Clevegen (bexmarilimab)
over2years
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
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PD-L1 (Programmed death ligand 1) • PD-1 (Programmed cell death 1)
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Clevegen (bexmarilimab)
over2years
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
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IFNG (Interferon, gamma) • TNFA (Tumor Necrosis Factor-Alpha) • CXCL10 (Chemokine (C-X-C motif) ligand 10)
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Clevegen (bexmarilimab)