Uplizna (inebilizumab-cdon) / Mitsubishi Tanabe, Amgen 
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 45 Diseases   15 Trials   15 Trials   525 News 


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  • ||||||||||  Soliris (eculizumab) / Alexion Pharma
    Journal:  Current and Emerging Biologics for the Treatment of Neuromyelitis Optica Spectrum Disorders. (Pubmed Central) -  Feb 23, 2021   
    The interleukin-6 receptor inhibitor satralizumab and anti-CD19 antibody inebilizumab have published positive phase III trial results and await approval in the near future...Although we will have even more evidence-based therapy options in the future, empirically used medications will keep their importance for now. The potential effect of new medications in AQP4 antibody seronegative NMOSD and patients with an NMOSD phenotype and antibodies to myelin oligodendrocyte glycoprotein (MOG) remains to be determined.
  • ||||||||||  Soliris (eculizumab) / Alexion Pharma, Ultomiris IV (ravulizumab IV) / Alexion Pharma
    Journal:  Emerging drugs for the treatment of neuromyelitis optica. (Pubmed Central) -  Feb 4, 2021   
    For the first time in this disease, class I treatment evidence is available, but long-term data will be necessary to confirm the overall promising study results of the compounds close to approval. While drug development still centers around AQP4 antibody seropositive patients, current and future research requires consideration of possible diverging treatment demands for the smaller group of seronegative patients and patients with presence of MOG antibodies.
  • ||||||||||  Soliris (eculizumab) / Alexion Pharma
    Review, Journal:  New therapies for neuromyelitis optica spectrum disorder. (Pubmed Central) -  Jan 29, 2021   
    WHERE NEXT?: Despite the rarity of neuromyelitis optica spectrum disorder, a relative abundance of preventive treatment options now exists. In the future, trials should focus on areas of unmet need, including aquaporin-4 seronegative disease, and on development of treatments for acute relapses and for recovery from autoimmune attacks in the CNS.
  • ||||||||||  Soliris (eculizumab) / Alexion Pharma
    [VIRTUAL] NMO and antiMOG: Updates on Diagnosis and Treatment (Scientific Program Auditorium) -  Jan 27, 2021 - Abstract #ACTRIMSForum2021ACTRIMS_Forum_79;    
    The availability of proven attack prevention biologics for NMOSD provides new hope for patients with NMOSD. Improved understanding of MOGAD phenotype, natural history and immunopathologic mechanisms of disease combined with optimized MOG-IgG detection assays will allow development of international diagnostic criteria and assist in drug trial design.
  • ||||||||||  Uplizna (inebilizumab-cdon) / Mitsubishi Tanabe, Amgen
    Trial completion, Trial completion date:  N-MOmentum: A Clinical Research Study of Inebilizumab in Neuromyelitis Optica Spectrum Disorders (clinicaltrials.gov) -  Jan 22, 2021   
    P2/3,  N=231, Completed, 
    Improved understanding of MOGAD phenotype, natural history and immunopathologic mechanisms of disease combined with optimized MOG-IgG detection assays will allow development of international diagnostic criteria and assist in drug trial design. Active, not recruiting --> Completed | Trial completion date: Oct 2022 --> Nov 2020
  • ||||||||||  Arzerra (ofatumumab) / Novartis, Genmab, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
    Review, Journal:  Targeting B cells to modify MS, NMOSD, and MOGAD: Part 2. (Pubmed Central) -  Jan 14, 2021   
    The safety profile of long-term B-cell depletion in MS, NMOSD, and MOGAD will be highlighted. Finally implications of the current coronavirus disease 2019 pandemic on the management of patients with these disorders and the use of B cell-depleting agents will be discussed.
  • ||||||||||  Actemra IV (tocilizumab) / Roche, JW Pharma, Soliris (eculizumab) / Alexion Pharma, Ultomiris IV (ravulizumab IV) / Alexion Pharma
    Review, Journal:  B Cells and Antibodies as Targets of Therapeutic Intervention in Neuromyelitis Optica Spectrum Disorders. (Pubmed Central) -  Jan 10, 2021   
    In this article, we review current pathogenetic concepts in NMOSD with a focus on the role of B cells and autoantibodies as major contributors to the propagation of these diseases. Lastly, by highlighting promising experimental and future treatment options, we aim to round up the current state of knowledge on the therapeutic arsenal in NMOSD.
  • ||||||||||  Journal:  Antibodies to watch in 2020. (Pubmed Central) -  Jan 9, 2021   
    P3
    Of the 79 antibodies in late-stage studies, 40 were undergoing evaluation as treatments for cancer, and potentially 9 of these (belantamab mafodotin, oportuzumab monatox, margetuximab, dostarlimab, spartalizumab, 131I-omburtamab, loncastuximab tesirine, balstilimab, and zalifrelimab) may enter regulatory review in late 2019 or in 2020. Overall, the biopharmaceutical industry's clinical pipeline of antibody therapeutics is robust, and should provide a continuous supply of innovative products for patients in the future.
  • ||||||||||  Uplizna (inebilizumab-cdon) / Mitsubishi Tanabe, Amgen
    Enrollment open:  MITIGATE: A Study of Inebilizumab Efficacy and Safety in IgG4- Related Disease (clinicaltrials.gov) -  Nov 12, 2020   
    P3,  N=160, Recruiting, 
    Overall, the biopharmaceutical industry's clinical pipeline of antibody therapeutics is robust, and should provide a continuous supply of innovative products for patients in the future. Not yet recruiting --> Recruiting
  • ||||||||||  Soliris (eculizumab) / Alexion Pharma
    Review, Journal:  Update on neuromyelitis optica spectrum disorder. (Pubmed Central) -  Oct 11, 2020   
    Not yet recruiting --> Recruiting Recent research in NMOSD has resulted in improved diagnosis and approved treatments.
  • ||||||||||  Uplizna (inebilizumab-cdon) / Mitsubishi Tanabe, Amgen
    Enrollment open:  MINT: Myasthenia Gravis Inebilizumab Trial (clinicaltrials.gov) -  Sep 16, 2020   
    P3,  N=252, Recruiting, 
    Wide heterogeneity in evidence warrants more robust trial designs investigating long-term treatments for this disease. Not yet recruiting --> Recruiting
  • ||||||||||  Soliris (eculizumab) / Alexion Pharma
    Journal:  Update on neuromyelitis optica spectrum disorder. (Pubmed Central) -  Sep 9, 2020   
    Not yet recruiting --> Recruiting Recent research in NMOSD has resulted in improved diagnosis and approved treatments.
  • ||||||||||  Uplizna (inebilizumab) / Viela Bio
    [VIRTUAL] Pharmacodynamic modeling and exposure-response assessment of inebilizumab in subjects with neuromyelitis optica spectrum disorders () -  Sep 3, 2020 - Abstract #MSDC2020MSDC_1613;    
    P2/3
    Subjects with low, medium and high PK exposure had a similar hazard ratio of AC-determined NMOSD attack for inebilizumab.Conclusions The pharmacodynamic modeling and exposure-response analyses of primary and key secondary endpoints confirmed effective depletion of B cells is achieved with 300 mg dose administered as an IV infusion on Day 1 and Day 15 and every 6 months thereafter. The PK variability between patients had no apparent effect on the hazard ratio for NMOSD attack.
  • ||||||||||  Uplizna (inebilizumab-cdon) / Mitsubishi Tanabe, Amgen
    New P3 trial:  MINT: Myasthenia Gravis Inebilizumab Trial (clinicaltrials.gov) -  Aug 23, 2020   
    P3,  N=252, Not yet recruiting, 
  • ||||||||||  Uplizna (inebilizumab) / Viela Bio
    [VIRTUAL] AQP4-IgG seronegative patient outcomes in the N-MOmentum trial of inebilizumab in neuromyelitis optica spectrum disorder () -  Aug 16, 2020 - Abstract #MSDC2020MSDC_268;    
    At 120 days into the open-label period (OLP), during which all participants received inebilizumab, the AAR in AQP4− participants (n=17) remained low (0.069 [0.014–0.202]). No attacks were seen in any AQP4−, MOG+ or double seronegative patient during the OLP.Conclusions The N-MOmentum trial provides clinically important insight on the difficulty of correctly diagnosing AQP4− NMOSD and suggests that inebilizumab may have a benefit on AAR in these patients.
  • ||||||||||  Uplizna (inebilizumab) / Viela Bio
    [VIRTUAL] Serum neurofilament light chain levels correlate with attack-related disability in neuromyelitis optica spectum disorder () -  Aug 16, 2020 - Abstract #MSDC2020MSDC_235;    
    P2/3
    N-MOmentum is a randomized, placebo-controlled, double-masked trial of inebilizumab, a B-cell-depleting monoclonal antibody (NCT02200770).Objectives Investigate relationships of NfL, UCH-L1, Tau and serum (s)GFAP to disease activity and Expanded Disability Status Scale (EDSS) disability in N-MOmentum trial participants with either AQP4-immunoglobulin G (IgG) seropositive or seronegative NMOSD.Methods Serum biomarkers NfL, UCH-L1, Tau and sGFAP were measured using the single molecular array (SIMOA; Quanterix) in 1260 serial and attack-related samples from N-MOmentum participants (n=215) and healthy controls (HC; n=25).Results At baseline, biomarkers were elevated in subsets of patients with NMOSD (NfL, 16%; UCH-L1, 6%; Tau, 12%; sGFAP, 29%); NfL and UCH-L1 levels correlated with sGFAP (r=0.53 [p<0.001] and 0.18 [p=0.007])...Following attacks, NfL correlated with EDSS score at attack assessments (R=0.55; p<0.001); other biomarkers did not correlate with EDSS score after controlling for NfL levels.Conclusions In NMOSD, serum NfL, UCH-L1 and Tau levels were higher than in HC; increased baseline sGFAP levels were associated with greater attack risk. Although sGFAP levels showed the greatest increase following attacks, NfL correlated with attack-related disability.
  • ||||||||||  Uplizna (inebilizumab-cdon) / Mitsubishi Tanabe, Amgen
    Phase classification:  ExTINGUSH: The ExTINGUISH Trial of Inebilizumab in NMDAR Encephalitis (clinicaltrials.gov) -  Jun 8, 2020   
    P2,  N=116, Not yet recruiting, 
    Although sGFAP levels showed the greatest increase following attacks, NfL correlated with attack-related disability. Phase classification: P2/3 --> P2
  • ||||||||||  Erbitux (cetuximab) / Eli Lilly, EMD Serono, Herceptin (trastuzumab) / Roche
    [VIRTUAL] miRNA-629: A circulating exosomal biomarker of NK cell function (Virtual Meeting: All Session Times Are U.S. EDT) -  Apr 13, 2020 - Abstract #AACRI2020AACR-I_368;    
    NK cells over-expressing miR-629 also showed a decreased killing capacity in ADCC assays with cetuximab and trastuzumab, as shown with Inebilizumab.Together, this work reveals a role for miR-629 in altering NK function and highlights the potential to use miR-629 as a biomarker of response to ADCC-mediated therapeutics across multiple cancer indications. More detailed analyses of clinical outcome with miR-629 expression in larger trials will be necessary to confirm these results.
  • ||||||||||  Soliris (eculizumab) / Alexion Pharma, efgartigimod IV (ARGX-113 IV) / argenx, Broteio, Rituxan (rituximab) / Roche, Biogen
    Review, Journal:  Immunotherapy in myasthenia gravis in the era of biologics. (Pubmed Central) -  Jan 30, 2020   
    Belimumab, an antibody against the B cell trophic factor BAFF, was ineffective in phase III trials, and efgartigimod, which depletes antibodies, was effective in a phase II study...Checkpoint inhibitors can trigger MG in some patients, necessitating early intervention. Increased availability of new biologics provides targeted immunotherapies and the opportunities to develop more specific therapies.