entolimod (STAT-600) / Coeptis 
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  • ||||||||||  entolimod (STAT-600) / Coeptis
    Journal:  The role of TRIF protein in regulating the proliferation and antigen presentation ability of myeloid dendritic cells through the ERK1/2 signaling pathway in chronic low-grade inflammation of intestinal mucosa mediated by flagellin-TLR5 complex signal. (Pubmed Central) -  Jan 12, 2024   
    Mouse bone marrow-derived DC line DC2.4 was divided into four groups: control group (BC) was DC2.4 cells cultured normally; flagellin single signal stimulation group (DC2.4+CBLB502) was DC2.4 cells stimulated with flagellin derivative CBLB502 during culture; TLR5-flagellin complex signal stimulation group (ov-TLR5-DC2.4+CBLB502) was flagellin derivative CBLB502 stimulated ov-TLR5-DC2.4 cells with TLR5 gene overexpression; TRIF signal interference group (ov-TLR5-DC2.4+CBLB502+Pepinh-TRIFTFA) was ov-TLR5-DC2.4 cells with TLR5 gene overexpression stimulated with flagellin derivative CBLB502 and intervened with TRIF-specific inhibitor Pepinh-TRIFTFA...After stimulation of flagellin protein-TLR5 complex signal, TRIF protein and p-ERK1/2 protein expression in myeloid dendritic cells were significantly up-regulated, accompanied by increased proliferation activity and maturity of DCs, enhanced antigen presentation function, increased secretion of pro-inflammatory cytokines IL-12 and IL-4. This process can be inhibited by the specific inhibitor of TRIF signal, suggesting that the TLR5-TRIF-ERK1/2 pathway may play an important role in abnormal immune response and mucosal chronic inflammation infiltration mediated by flagellin protein in DCs, which can provide a basis for our subsequent animal experiments.
  • ||||||||||  entolimod (STAT-600) / Coeptis
    Journal, IO biomarker:  The inducible secreting TLR5 agonist, CBLB502, enhances the anti-tumor activity of CAR133-NK92 cells in colorectal cancer. (Pubmed Central) -  Oct 4, 2023   
    Armed with a CBLB502 TLR5 agonist, CAR133-NK92 cells were shown to be capable of specifically eliminating CD133-positive colon cancer cells in a CAR133-dependent manner and indirectly eradicating CD133-negative colon cancer cells in a CBLB502-specific endogenous immune response manner. This study describes a novel technique for optimizing CAR-T/NK cells for the treatment of antigenically-diverse solid tumors.
  • ||||||||||  entolimod (STAT-600) / Coeptis
    Trial completion, Enrollment change, Trial completion date:  Entolimod on Immunosenescence in Healthy Geriatric Subjects Receiving Influenza Vaccination (clinicaltrials.gov) -  May 3, 2022   
    P2,  N=61, Completed, 
    In general, the developed dual-chambered nanoparticle can trigger multifaceted immune responses and shows great potential for mucosal vaccine development. Active, not recruiting --> Completed | N=100 --> 61 | Trial completion date: Dec 2022 --> Mar 2022
  • ||||||||||  entolimod (STAT-600) / Statera BioPharma
    Review, Journal:  Entolimod as a radiation countermeasure for acute radiation syndrome. (Pubmed Central) -  Dec 21, 2021   
    The US Food and Drug Administration (FDA) has granted investigational new drug, fast-track, and orphan drug statuses to entolimod. Its safety, efficacy, and animal-to-human dose conversion data allowed its progression with a pre-emergency use authorization application, which remains under review with the FDA.
  • ||||||||||  entolimod (CBLB502) / Statera BioPharma
    Journal:  Signaling through TLR5 mitigates lethal radiation damage by neutrophil-dependent release of MMP-9. (Pubmed Central) -  Sep 30, 2021   
    A TLR5 agonist, entolimod, is among the most powerful experimental radiation countermeasures and shows efficacy in rodents and non-human primates as a prophylactic (radioprotection) and treatment (radiomitigation) modality...Importantly, recombinant MMP-9 by itself has radiomitigative activity and, in the absence of neutrophils, accelerates the recovery of the hematopoietic system. Unveiling this novel TLR5-neutrophil-MMP-9 axis of radiomitigation opens new opportunities for the development of efficacious radiation countermeasures to treat ARS following accidental radiation disasters.
  • ||||||||||  entolimod (CBLB502) / Statera BioPharma
    Journal:  Synergistic effect of the TLR5 agonist CBLB502 and its downstream effector IL-22 against liver injury. (Pubmed Central) -  Sep 22, 2021   
    In IL-22 knockout mice, the loss of IL-22 resulted in a decrease of hepatic STAT3 activation, a reduction in the cytoprotective signature, and a loss of hepatoprotection following ischemia-reperfusion-induced liver injury. Taken together, these findings suggest that CBLB502 protects the liver by increasing hepatocyte resistance to acute liver injury through the cooperation of TLR5-NF-κB and IL-22-STAT3 signaling pathways.
  • ||||||||||  GP532 / Genome Protection, entolimod (CBLB502) / Cleveland Biolabs
    Journal, IO biomarker:  A deimmunized and pharmacologically optimized Toll-like receptor 5 agonist for therapeutic applications. (Pubmed Central) -  Aug 6, 2021   
    Like entolimod, GP532 demonstrated potent prophylactic and therapeutic efficacy in mouse models of radiation-induced death and tissue damage. These results establish GP532 as an optimized TLR5 agonist suitable for multi-dose therapies and for patients with high titers of preexisting flagellin-neutralizing antibodies.
  • ||||||||||  entolimod (STAT-600) / Coeptis
    Enrollment closed:  Entolimod on Immunosenescence in Healthy Geriatric Subjects Receiving Influenza Vaccination (clinicaltrials.gov) -  Jun 1, 2021   
    P2,  N=100, Active, not recruiting, 
    The results of this study, thus demonstrate that KMRC011 could potentially be used as a medical countermeasure for the treatment of acute radiation exposure. Recruiting --> Active, not recruiting
  • ||||||||||  entolimod (CBLB502) / Cleveland Biolabs
    Preclinical, Journal, IO biomarker:  Toll-like receptor 5-mediated signaling enhances liver regeneration in mice. (Pubmed Central) -  Apr 2, 2021   
    We reveal that TLR5 activation contributes to the initial events of liver regeneration after PHx. Our findings demonstrate that TLR5 signaling positively regulates liver regeneration and suggest the potential of TLR5 agonist to promote liver regeneration.
  • ||||||||||  entolimod (STAT-600) / Coeptis
    Trial completion date, Trial primary completion date:  Entolimod on Immunosenescence in Healthy Geriatric Subjects Receiving Influenza Vaccination (clinicaltrials.gov) -  Feb 9, 2021   
    P2,  N=100, Recruiting, 
    Our findings demonstrate that TLR5 signaling positively regulates liver regeneration and suggest the potential of TLR5 agonist to promote liver regeneration. Trial completion date: Apr 2021 --> Apr 2022 | Trial primary completion date: Jan 2021 --> Mar 2022
  • ||||||||||  entolimod (STAT-600) / Coeptis
    Trial completion:  Entolimod, an Adjuvant for Vaccine Augmentation (clinicaltrials.gov) -  Aug 31, 2020   
    P1,  N=40, Completed, 
    Thus, we present histone gene downregulation by radioprotectants, together with the biological functions of miRNA, lncRNA, and mRNA, to explain the mechanism underlying radioprotection. Active, not recruiting --> Completed
  • ||||||||||  bleomycin / Generic mfg., BMS, entolimod (CBLB502) / Cleveland Biolabs
    [VIRTUAL] TLR5 Protects Against Pulmonary Fibrosis (ATS 2020 Virtual) -  Jul 6, 2020 - Abstract #ATSI2020ATS-I_3638;    
    Collectively, these data suggest that TLR5 may function to protect the lung against bacterial injuries that could otherwise lead to fibrosis. Additionally, the present data suggests that Entolimod may provide a novel therapeutic approach for the treatment of pulmonary fibrosis.
  • ||||||||||  entolimod (CBLB502) / Cleveland Biolabs
    Journal, IO Biomarker:  TLR5 agonist entolimod reduces the adverse toxicity of TNF while preserving its antitumor effects. (Pubmed Central) -  Apr 23, 2020   
    Entolimod did not interfere with the antitumor activity of TNF in mouse hepatocellular and colorectal tumor models. These results support further development of TLR5 agonists to increase tissue resistance to cytotoxic cytokines, reduce the risk of septic shock and enable safe systemic application of TNF as an anticancer therapy.
  • ||||||||||  bleomycin / Generic mfg., BMS, entolimod (CBLB502) / Cleveland Biolabs
    TLR5 Protects Against Pulmonary Fibrosis (PENNSYLVANIA CONVENTION CENTER, Hall D-E (200 Level), Area A) -  Mar 15, 2020 - Abstract #ATS2020ATS_6020;    
    Collectively, these data suggest that TLR5 may function to protect the lung against bacterial injuries that could otherwise lead to fibrosis. Additionally, the present data suggests that Entolimod may provide a novel therapeutic approach for the treatment of pulmonary fibrosis.
  • ||||||||||  entolimod (CBLB502) / Cleveland Biolabs
    Journal:  Toll-like receptors and radiation protection. (Pubmed Central) -  Oct 4, 2019   
    TLR5 ligand CBLB502 was reported to alleviate bone marrow and intestinal injuries in mice and rhesus monkeys...Moreover, some kinds of TLR agonists, such as TLR2/6 co-agonist CBLB613, were reported to be more effective in radioprotection than single TLR agonist. In conclusion, TLRs and their ligands provide novel strategies for radiation protection in nuclear accidents as well as protection of normal tissues during cancer radiotherapy.
  • ||||||||||  entolimod (CBLB502) / Cleveland Biolabs
    Journal:  TLR5 binding and activation by KMRC011, a flagellin-derived radiation countermeasure. (Pubmed Central) -  Jun 5, 2019   
    Further comparative analysis demonstrated that KMRC011 binds and activates TLR5 in a mode similar to that of entolimod. Thus, we propose that KMRC011 can be used in place of entolimod as a second-generation radiation countermeasure that shows none of the immunogenic side effects derived from the entolimod ancillary region.
  • ||||||||||  entolimod (CBLB502) / Cleveland Biolabs
    Biomarker, Clinical, Journal:  In silico modeling to optimize interpretation of liver safety biomarkers in clinical trials. (Pubmed Central) -  Oct 17, 2018   
    The results from analyses conducted with DILIsym have been reported to the FDA to support the safety of entolimod and cimaglermin alfa after elevations in serum alanine aminotransferase and/or bilirubin halted clinical development...This approach is increasingly being applied in clinical trials to more precisely assess the degree of hepatocellular injury and its functional impact. This new approach holds the promise of more accurately defining DILI risk in smaller clinical trials.
  • ||||||||||  entolimod (STAT-600) / Coeptis
    Enrollment closed:  Entolimod, an Adjuvant for Vaccine Augmentation (clinicaltrials.gov) -  Sep 21, 2018   
    P1,  N=40, Active, not recruiting, 
    This new approach holds the promise of more accurately defining DILI risk in smaller clinical trials. Recruiting --> Active, not recruiting
  • ||||||||||  entolimod (STAT-600) / Coeptis
    Trial completion date:  Entolimod, an Adjuvant for Vaccine Augmentation (clinicaltrials.gov) -  Mar 9, 2018   
    P1,  N=40, Recruiting, 
    Recruiting --> Active, not recruiting Trial completion date: Apr 2018 --> Dec 2019
  • ||||||||||  entolimod (STAT-600) / Coeptis
    Enrollment open:  Entolimod, an Adjuvant for Vaccine Augmentation (clinicaltrials.gov) -  Jan 18, 2018   
    P1,  N=40, Recruiting, 
    Trial completion date: Apr 2018 --> Dec 2019 Not yet recruiting --> Recruiting
  • ||||||||||  entolimod (STAT-600) / Coeptis
    Trial initiation date:  Entolimod, an Adjuvant for Vaccine Augmentation (clinicaltrials.gov) -  Sep 7, 2017   
    P,  N=40, Not yet recruiting, 
    Not yet recruiting --> Recruiting Initiation date: Jun 2017 --> Oct 2017
  • ||||||||||  entolimod (CBLB502) / Cleveland Biolabs
    Journal:  Mitigation of Radiation-Induced Epithelial Damage by the TLR5 Agonist Entolimod in a Mouse Model of Fractionated Head and Neck Irradiation. (Pubmed Central) -  Aug 20, 2017   
    While both tested regimens of entolimod significantly reduced the extent of radiation damage and accelerated restoration of normal structure in all tissues analyzed, administration of entolimod 1 h after each irradiation was more effective than treatment 30 min before irradiation. These results support the potential clinical use of entolimod as an adjuvant for improving the therapeutic index of head and neck cancer radiotherapy by reducing the radiation toxicity in normal tissues.
  • ||||||||||  entolimod (STAT-600) / Coeptis
    Enrollment closed, Trial primary completion date:  Clinical Study of Safety and Tolerability of CBLB502 as a Neo-adjuvant Treatment in Patients With Colorectal Cancer (clinicaltrials.gov) -  Feb 9, 2017   
    P2,  N=40, Active, not recruiting, 
    These results support the potential clinical use of entolimod as an adjuvant for improving the therapeutic index of head and neck cancer radiotherapy by reducing the radiation toxicity in normal tissues. Recruiting --> Active, not recruiting | Trial primary completion date: Sep 2016 --> Feb 2017