LENZ (lenzilumab) / Humanigen 
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 16 Diseases   3 Trials   3 Trials   683 News 


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  • ||||||||||  azacitidine / Generic mfg.
    Clinical, Review, Journal:  Increasing recognition and emerging therapies argue for dedicated clinical trials in chronic myelomonocytic leukemia. (Pubmed Central) -  Nov 21, 2021   
    To date, approved drugs for CMML treatment are HMA, including azacitidine, decitabine, and more recently the oral combination of decitabine and cedazuridine...Several novel agents, such as sotatercept, ruxolitinib, lenzilumab, and tagraxofusp have shown promising clinical efficacy in CMML...This review focuses on recent therapeutic advances and innovative treatment strategies in CMML, including global and molecularly targeted approaches. We also discuss what may help to make progress in the design of rationally derived and disease-modifying therapies for CMML.
  • ||||||||||  [VIRTUAL] Evaluation of treatment approaches for hospitalized Covid-19 patients () -  Nov 10, 2021 - Abstract #BTSWMI2021BTS_WM_I_217;    
    2 Inpatient treatments included the anti-viral: remdesivir 3,4 ; and immune modulators: baricitinib 5 , and lenzilumab...The NNT for lenzilumab improved with refinement of concomitant medications and patient phenotype. NNT provides a simple measure for comparative analyses that helps inform clinical decision-making and resource allocation.
  • ||||||||||  lenzilumab (KB003) / Humanigen
    Optimized Inhibition of GM-CSF in Preclinical Models of Anti-CD19 Chimeric Antigen Receptor T Cell Therapy (GWCC - Hall B5, Level 1) -  Nov 5, 2021 - Abstract #ASH2021ASH_4421;    
    Having demonstrated that GM-CSFRα is significantly upregulated on stimulated CART19 cells, we aimed to determine the impact of GM-CSF neutralization (clinical-grade anti-GM-CSF antibody, lenzilumab, 10 µg/mL) versus GM-CSFRα blockade (research-grade antibody, 10 µg/mL) on CART19 cell function and CART cell-monocyte interactions...In summary, our findings indicate significant differences on CART cell functions and CART cell-monocyte interactions when a specific cytokine, GM-CSF, is neutralized compared to blocking its receptor. Further mechanistic studies are ongoing to assess the functions of GM-CSFRα k/o and GM-CSF k/o CART cells.
  • ||||||||||  Actemra IV (tocilizumab) / Roche, JW Pharma, lenzilumab (KB003) / Humanigen
    A Phase 2/3 Randomized, Placebo-Controlled, Open-Label, Multi-Center Trial of Lenzilumab to Improve the Safety and Efficacy of CAR-T Cell Therapy in Adults with Relapsed or Refractory Large B-Cell Lymphoma (The SHIELD Study) (GWCC - Hall B5, Level 1) -  Nov 5, 2021 - Abstract #ASH2021ASH_3342;    
    All three approved CD19-directed CAR-T therapies (axicabtagene ciloleucel, tisagenlecleucel, lisocabtagene maraleucel) are associated with toxicities, including cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) that can be severe, resulting in non-relapse mortality, ICU admission, and significant non-drug related health resource utilization which represent barriers to access and adoption (Nabhan, et al...Blood 2016), which helps explain why the prophylactic administration of tocilizumab is not effective in reducing the overall incidence of CRS or ICANS, as this cytokine is downstream in the inflammatory cascade...Secondary endpoints include incidence of all grades and grade > 3 CRS and/or ICANS, respectively; ORR and CR at 1, 3, 6, 12 months; durability of CR; progression-free survival, overall survival and health related quality of life using validated patient reported outcome measures. In addition, the study will explore the CRS and ICANS grading criteria that have been utilized with each of the approved CAR-Ts.
  • ||||||||||  lenzilumab (KB003) / Humanigen
    Lenzilumab. (Twitter) -  Sep 29, 2021   
  • ||||||||||  lenzilumab (KB003) / Humanigen
    #lenzilumab (Twitter) -  Sep 7, 2021   
  • ||||||||||  lenzilumab (KB003) / Humanigen
    #lenzilumab (Twitter) -  Sep 7, 2021   
  • ||||||||||  lenzilumab (KB003) / Humanigen
    Lenzilumab (Twitter) -  Aug 30, 2021   
  • ||||||||||  LENZ (lenzilumab) / Humanigen
    Enrollment change:  ACTIV-5 / Big Effect Trial (BET-B) for the Treatment of COVID-19 (clinicaltrials.gov) -  Aug 18, 2021   
    P2,  N=400, Recruiting, 
    NCT04351152 CLINICAL IMPLICATIONS: CRP, a routine laboratory test can be used to determine in which patients, and at what times, lenzilumab treatment may provide the greatest clinical benefits and outcomes. N=200 --> 400