edicotinib (PRV-6527) / Sanofi 
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 7 Diseases   1 Trial   1 Trial   40 News 
  • ||||||||||  edicotinib (PRV-6527) / Provention Bio
    Biomarker, Journal:  Pharmacological modulation of TSPO in microglia/macrophages and neurons in a chronic neurodegenerative model of prion disease. (Pubmed Central) -  Apr 14, 2023   
    These findings suggest that [3H]PBR28 quantitative autoradiography in combination with immunohistochemistry are important translational tools for detecting and quantifying neuroinflammation, and its treatments, in neurodegenerative disease. Furthermore, we demonstrate that although TSPO overexpression in the ME7 brains was driven by various cell types, the therapeutic effect of the CSF1R inhibitor was primarily to modulate TSPO expression in microglia and neurons, which identifies an important route of biological action of this particular CSF1R inhibitor and provides an example of a cell-specific effect of this type of therapeutic agent on the neuroinflammatory process.
  • ||||||||||  Darzalex (daratumumab) / J&J, Conmana (icotinib) / Betta Pharma, edicotinib (PRV-6527) / Provention Bio
    Journal:  Immune and pathologic responses in patients with localized prostate cancer who received daratumumab (anti-CD38) or edicotinib (CSF-1R inhibitor). (Pubmed Central) -  Mar 25, 2023   
    Decreases in CD38 immune cells were observed in prostate tumors, bone marrow, and PBMCs with daratumumab, but changes in CSF-1R immune cells were not consistently observed with edicotinib. Neither myeloid-targeted agent alone was sufficient to generate antitumor responses in prostate cancer; thus, combinations with agents to induce T cell infiltration (eg, ICTs) will be needed to overcome the immunosuppressive prostate TME.
  • ||||||||||  Darzalex (daratumumab) / J&J, edicotinib (PRV-6527) / Sanofi
    Trial completion date, Trial primary completion date, Surgery, Metastases:  Daratumumab or FMS Inhibitor JNJ-40346527 Before Surgery in Treating Patients With High-Risk, Resectable Localized or Locally Advanced Prostate Cancer (clinicaltrials.gov) -  Feb 28, 2022   
    P1,  N=33, Active, not recruiting, 
    Neither myeloid-targeted agent alone was sufficient to generate antitumor responses in prostate cancer; thus, combinations with agents to induce T cell infiltration (eg, ICTs) will be needed to overcome the immunosuppressive prostate TME. Trial completion date: Jun 2020 --> Jun 2023 | Trial primary completion date: Jun 2020 --> Jun 2023
  • ||||||||||  edicotinib (PRV-6527) / Provention Bio
    Inhibiting CSF1 receptor signaling dampens microglial proliferation and reduces Tau deposition in mice (Virtual Only) -  Dec 20, 2021 - Abstract #Neuroscience2021Neuroscience_1763;    
    Here we tested selective brain penetrant small molecule CSF1R antagonist: JNJ-40346527 (JNJ527) to inhibit microglia proliferation...These ligands can potentially serve as target engagement biomarkers for clinical investigation of CSF1R inhibitors. Overall, these findings strongly support the inhibition of CSF1R to reduce microglial proliferation as a promising immunomodulatory strategy for the treatment of AD.
  • ||||||||||  edicotinib (PRV-6527) / Sanofi
    Enrollment change, Trial completion date, Trial termination, Trial primary completion date:  NCI-2018-00869: JNJ-40346527 in Treating Participants With Relapsed or Refractory Acute Myeloid Leukemia (clinicaltrials.gov) -  Nov 17, 2020   
    P2,  N=3, Terminated, 
    Active, not recruiting --> Completed N=28 --> 3 | Trial completion date: Dec 2023 --> Sep 2020 | Active, not recruiting --> Terminated | Trial primary completion date: Dec 2022 --> Sep 2020; Not enough enrollment to determine efficacy
  • ||||||||||  edicotinib (PRV-6527) / Sanofi
    Trial primary completion date:  MICAD: MIcroglial Colony Stimulating Factor-1 Receptor (CSF1R) in Alzheimer's Disease (clinicaltrials.gov) -  Oct 28, 2020   
    P1,  N=54, Not yet recruiting, 
    N=28 --> 3 | Trial completion date: Dec 2023 --> Sep 2020 | Active, not recruiting --> Terminated | Trial primary completion date: Dec 2022 --> Sep 2020; Not enough enrollment to determine efficacy Trial primary completion date: Nov 2020 --> Dec 2021
  • ||||||||||  edicotinib (PRV-6527) / J&J, Provention Bio
    Biomarker, Preclinical, Journal:  CSF1R inhibitor JNJ-40346527 attenuates microglial proliferation and neurodegeneration in P301S mice. (Pubmed Central) -  Jun 18, 2020   
    Then, we showed for the first time that blockade of microglial proliferation and modification of microglial phenotype leads to an attenuation of tau-induced neurodegeneration and results in functional improvement in P301S mice. Overall, this work strongly supports the potential for inhibition of CSF1R as a target for the treatment of Alzheimer's disease and other tau-mediated neurodegenerative diseases.
  • ||||||||||  edicotinib (PRV-6527) / Sanofi
    Trial initiation date:  MICAD: MIcroglial Colony Stimulating Factor-1 Receptor (CSF1R) in Alzheimer's Disease (clinicaltrials.gov) -  Mar 24, 2020   
    P1,  N=54, Not yet recruiting, 
    Overall, this work strongly supports the potential for inhibition of CSF1R as a target for the treatment of Alzheimer's disease and other tau-mediated neurodegenerative diseases. Initiation date: Nov 2019 --> May 2020