Gamifant (emapalumab-lzsg) / SOBI 
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 0 Diseases   4 Trials   4 Trials   250 News 


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  • ||||||||||  Soliris (eculizumab) / Alexion Pharma
    [VIRTUAL] ASH Poster Walk on Immunotherapies: A Walk Down Immunotherapy Lane: Watch Out for the CARs: Live Q&A (On Demand) -  Dec 2, 2020 - Abstract #ASH2020ASH_5794;    
    The following abstracts will be featured during this session: A Novel Approach for Treatment of T-Cell Malignancies: Targeting T-Cell Receptor Vβ Families, Jie Wang High IL-15 Serum Concentrations Are Associated with Response to CD19 CAR T-Cell Therapy and Robust In Vivo CAR T-Cell Kinetics, Jordan Gauthier Antibiotic Therapy and Low Gut Microbiome Diversity Is Associated with Decreased Response and High Toxicity in BCP-ALL and DLBCL Patients after Treatment with CD19. CAR T-Cells, Viktoria Blumenberg Sensitivity Analysis of Overall Response Rate (ORR) with Emapalumab in Children with Primary Hemophagocytic Lymphohistiocytosis (HLH), Michael Jordan Molecular Imaging of Chimeric Antigen Receptor T Cells By ICOS-Immunopet, Federico Simonetta Results of the Pegasus Phase 3 Randomized Trial Demonstrating Superiority of the C3 Inhibitor, Pegcetacoplan, Compared to Eculizumab in Patients with Paroxysmal Nocturnal Hemoglobinuria, Peter Hillmen
  • ||||||||||  Gamifant (emapalumab) / SOBI, Jakafi oral (ruxolitinib) / Novartis, Incyte, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
    [VIRTUAL] A Case Series: The Novel Use of Emapalumab and Ruxolitinib in Acquired Malignancy-Associated HLH in Pediatric Patients () -  Nov 5, 2020 - Abstract #ASH2020ASH_4830;    
    Gemcitabine and oxaliplatin were started as treatment for her lymphoma as the driver of her HLH, but she developed acute decompensation with hemodynamic instability and multi-organ system failure...Due to the toxicity of treatment options for often concurrent processes of malignancy, infection, and HLH, novel therapeutics such as emapalumab and ruxolitinib are required and should be evaluated in larger studies. Furthermore, guidelines for the management of pediatric m-HLH are required with inclusion of adjustments to standard therapy based on toxicity, inciting factors, concurrent processes, and the incorporation of novel therapeutics to achieve improved outcomes.
  • ||||||||||  Gamifant (emapalumab) / SOBI
    [VIRTUAL] Sensitivity Analysis of Overall Response Rate (ORR) with Emapalumab in Children with Primary Hemophagocytic Lymphohistiocytosis (HLH) (Poster Hall (Virtual Meeting)) -  Nov 5, 2020 - Abstract #ASH2020ASH_4064;    
    P2/3
    The current analyses using different definitions of treatment response support the primary analysis results by having a numerically comparable point estimate to the primary endpoint, therefore confirming the positive benefit of emapalumab in patient's refractory or intolerant to conventional HLH therapies. Taken together, these findings also suggest that the clinically objective ORR, utilized in the pivotal emapalumab trial, may be used as a primary endpoint in primary HLH.
  • ||||||||||  Gamifant (emapalumab) / SOBI
    Journal:  Emapalumab for the treatment of hemophagocytic lymphohistiocytosis. (Pubmed Central) -  Oct 27, 2020   
    Additional studies of emapalumab are currently ongoing in adults and other pediatric populations. Here, we will review the pharmacology, safety and efficacy of emapalumab for the treatment of HLH.
  • ||||||||||  Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
    [VIRTUAL] Hemophagocytic Lymphohistiocytosis Presenting as Nephrotic Syndrome (On-Demand) -  Oct 11, 2020 - Abstract #KIDNEYWEEK2020KIDNEY_WEEK_2242;    
    He achieved sufficient remission with IFN-gamma blockade with emapalumab-lzsg to undergo stem cell transplant...Discussion Virus-induced HLH can result in podocytopathy manifesting as MCD which can have serious sequelae including irreversible renal damage leading to chronic kidney disease, hypertriglyceridemia and pericardial effusion. This nephrotic syndrome can improve with treatment of HLH with immunosuppression or stem cell transplant.
  • ||||||||||  Actemra IV (tocilizumab) / Roche, JW Pharma, Soliris (eculizumab) / Alexion Pharma
    Review, Journal:  COVID-19: review on latest available drugs and therapies against SARS-CoV-2. Coagulation and inflammation cross-talking. (Pubmed Central) -  Sep 9, 2020   
    The inflammatory phase includes therapeutic options like Tocilizumab, Anakinra, Baricitinib, Eculizumab, Emapalumab and Heparin...Coagulopathy is a common complication in severe cases, inflammation and coagulation are intertwined and cross-talking between these two responses is known to happen. A possible amplification of this cross-talking is suggested to be implicated in the severe cases that show both a cytokine storm and coagulopathy.
  • ||||||||||  Gamifant (emapalumab) / SOBI
    Journal:  Emapalumab in Primary Hemophagocytic Lymphohistiocytosis. (Pubmed Central) -  Aug 13, 2020   
    Conclusions The BTD program offers sponsors intensive multidisciplinary guidance and collaboration with FDA to enhance thoughtful, efficient development of drugs for pediatric tumors. No abstract available
  • ||||||||||  Gamifant (emapalumab) / SOBI
    Biomarker, Journal, IO Biomarker:  Role of IFNγ in immune-mediated graft failure occurring after allogeneic hematopoietic stem cell transplantation. (Pubmed Central) -  Jul 16, 2020   
    Altogether, these results suggest that IFNγ pathway plays a major role in graft failure occurring after hematopoietic stem cell transplantation. Increased serum levels of IFNγ and CXCL9 represent potential biomarkers useful for early diagnosis of graft failure and provide the rationale for exploring the therapeutic/preventive role of targeted neutralization of IFNγ.
  • ||||||||||  Gamifant (emapalumab) / SOBI
    Clinical, Clinical Trial,Phase II, Clinical Trial,Phase III, Journal:  Emapalumab in Children with Primary Hemophagocytic Lymphohistiocytosis. (Pubmed Central) -  May 21, 2020   
    P=N/A, P2/
    Emapalumab was an efficacious targeted therapy for patients with primary hemophagocytic lymphohistiocytosis. (Funded by NovImmune and the European Commission; NI-0501-04 and NI-0501-05 ClinicalTrials.gov numbers, NCT01818492 and NCT02069899.).
  • ||||||||||  Gamifant (emapalumab) / SOBI, cyclophosphamide intravenous / Generic mfg., Rituxan (rituximab) / Roche, Biogen, Zenyaku Kogyo
    [VIRTUAL] SUCCESSFUL RESCUE WITH EMAPALUMAB IN AN ADA-SCID PATIENT WITH REFRACTORY HEMOPHAGOCYTIC LYMPHOHISTIOCYTOSIS (HLH)- RELATED GRAFT FAILURE AND DISSEMINATED BCGITIS () -  May 16, 2020 - Abstract #EHA2020EHA_2605;    
    The patient received a second TCD-HSCT from the same donor after conditioning with fludarabine, cyclophosphamide, ATG and Rituximab...The conditioning regimen included etoposide, cyclophosphamide and ATG, while cyclosporin-A was given for graft-rejection prevention...The patient remains on anti-TB prophylaxis to mitigate the risk of reactivation in the presence of measurable levels of emapalumab. Conclusion Administration of emapalumab was safe and efficacious in treating severe secondary HLH after a salvage haplo-HSCT in an ADA‐SCID patient with multiple active infections, including TB.
  • ||||||||||  Decadron (dexamethasone) / Merck (MSD), Gamifant (emapalumab) / SOBI, Soliris (eculizumab) / Alexion Pharma
    THE USE OF EMAPALUMAB AS TREATMENT FOR A CRITICALLY ILL PATIENT WITH FAMILIAL HLH () -  Apr 3, 2020 - Abstract #ASPHO2020ASPHO_382;    
    In our patient with life threatening complications due to shiga toxin induced HUS, Emapalumab treated his HLH to allow recovery of his organ function. Given our experience, this medication appears to be an excellent option for the treatment of HLH, even in patients with significant co-morbidities.
  • ||||||||||  Gamifant (emapalumab) / SOBI
    PREDICTIVE PHARMACOKINETIC MODEL OF EMAPALUMAB PLASMA CONCENTRATIONS IN HEALTHY VOLUNTEERS () -  Apr 3, 2020 - Abstract #ASPHO2020ASPHO_298;    
    P1
    This model, together with information on (i) the neutralization of IFN-gamma by emapalumab in vitro and (ii) IFN-gamma production in HLH patients from the literature, was successfully used to select the dose for the first clinical study of emapalumab in patients with primary HLH and which formed the basis for the FDA approval in this indication. This research was funded by Sobi (formerly Novimmune).