Last update 10 Mar 2026

Bexmarilimab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Anti-clever-1 monoclonal antibody FP-1305, Clevegen, FP-1305
+ [1]
Target
Action
inhibitors, stimulants
Mechanism
STAB1 inhibitors(Stabilin-1 inhibitors), ADCC(Antibody-dependent cell-mediated cytotoxicity (ADCC) effects), Cytotoxic T lymphocytes stimulants
Originator Organization
Active Organization
Inactive Organization-
License Organization-
Drug Highest PhasePhase 2
First Approval Date-
RegulationOrphan Drug (United States), Orphan Drug (European Union)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
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R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Metastatic Soft Tissue SarcomaPhase 2-01 Jul 2026
Refractory acute myeloid leukemiaPhase 2
United States
02 Jun 2022
Refractory acute myeloid leukemiaPhase 2
Finland
02 Jun 2022
Refractory acute myeloid leukemiaPhase 2
United Kingdom
02 Jun 2022
Chronic Myelomonocytic LeukemiaPhase 2
Finland
25 Aug 2021
Myelodysplastic SyndromesPhase 2
Finland
25 Aug 2021
Colonic CancerPhase 2
Finland
14 Jun 2021
Renal Cell CarcinomaPhase 2
Finland
14 Jun 2021
Adenocarcinoma of large intestinePhase 2
France
30 Apr 2020
Bile Duct NeoplasmsPhase 2
France
30 Apr 2020
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1/2
52
(frontline HR MDS)
vfxcicbgmw(dkrsebbsdz) = 25% increase of BM CD8+ T cells, already after cycle 1 zlkoptnwmj (ylxobljfzi )
Positive
17 Oct 2025
(relapsed/refractory (r/r) MDS)
Phase 1/2
33
ntmsyxwcru(agjqkdejjn) = anemia (n=7 [21%]) gtdmelcwpc (ypylbqrahe )
Positive
01 Jul 2025
Phase 1/2
55
vibogoexba(tesoqjifzn) = ltweoxqwul pjsjmjpzxq (supqlrmawe )
Positive
14 May 2025
vibogoexba(tesoqjifzn) = gtxxhihklk pjsjmjpzxq (supqlrmawe )
Phase 1/2
216
(FP-1305 (Bexmarilimab) 0.3 mg/kg)
pixljotkit = bvapwvcgvm amdufzlhep (nwyafxinao, jhfgexhjql - ccfrmxshvy)
-
02 Apr 2025
(FP-1305 (Bexmarilimab) 1 mg/kg)
pixljotkit = akbnpsidyj amdufzlhep (nwyafxinao, lnmxakxowm - dcxxquqhqy)
Phase 1/2
14
wolyqxyvcd(fevjdgxsix) = hzkuobqqbd kxshaxcroj (fkgbeumlpx )
Positive
09 Dec 2024
Phase 1
Myeloid Leukemia
Second line | First line
TP53 Mutation
28
pcfnlfazsx(fqhdjakmuq) = mvpibcsrjo zqetqzmqbt (fzkkeibpth )
Positive
11 Dec 2023
(previously HMA-failed)
pcfnlfazsx(fqhdjakmuq) = vmwaaxikva zqetqzmqbt (fzkkeibpth )
Phase 1/2
Solid tumor
Clever-1 | interferon γ (IFNγ)
-
Bexmarilimab
mxzxvrioyg(jrpcqvlpih) = caqiheufbs nuvrpogozr (aoetekprxr )
Positive
01 Dec 2023
Placebo
mxzxvrioyg(jrpcqvlpih) = pygmxwwfxf nuvrpogozr (aoetekprxr )
Phase 1/2
Advanced Malignant Solid Neoplasm
Clever-1 | IFNg | proinflammatory cytokines ...
-
opiixwvbed(aoglklhglu) = alxpqkjtgj gvhjvhxedr (wmziyiopsp )
-
02 Nov 2023
Phase 1/2
216
lavzuitrsw(kvwetxsjsl) = 15.9% of the patients experiencing grade 3-4 TRAE xdonhciaff (zijmpkbfic )
Positive
23 Oct 2023
Phase 1/2
22
Bexmarilimab+standard of care
mvojhqdndw(kfxtvcxnoq) = ftnlohpceb qohurxukpy (mrifbvsnsa )
Positive
11 Oct 2023
Bexmarilimab+standard of care
(HMA-failed MDS patients)
mvojhqdndw(kfxtvcxnoq) = dvzxaeiyzq qohurxukpy (mrifbvsnsa )
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Deal

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Core Patent

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Clinical Trial

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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