Idefirix (imlifidase) / Hansa Biopharma, Sarepta Therap 
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 5 Diseases   9 Trials   9 Trials   217 News 


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  • ||||||||||  Thymoglobulin (anti-thymocyte globulin (rabbit)) / Sanofi, Idefirix (imlifidase) / Hansa Biopharma, Sarepta Therap
    Imlifidase for Kidney Transplantation of Highly Sensitized Patients with a Positive Crossmatch: The French Consensus Guidelines () -  May 12, 2024 - Abstract #EFI2024EFI_259;    
    Frequent post-transplant testing for DSA and systematic surveillance kidney biopsies are strongly recommended to monitor post-transplant DSA rebound and detect subclinical rejection. These French guidelines aim to provide valuable insights into refining the use and implementation of Imlifidase, a major breakthrough in kidney transplantation.
  • ||||||||||  Idefirix (imlifidase) / Hansa Biopharma, Sarepta Therap, Rituxan (rituximab) / Roche
    Delisting Strategy to Enable DSA Positive and Cross-Match Negative Kidney Transplantation in Hypersensitized Patients with 100% cPRA (108-AB, Level 1) -  May 6, 2024 - Abstract #ATC2024ATC_2896;    
    Upon kidney offer, if flow-cytometry (FC-XM) and complement-dependent cytotoxicity (CDC-XM) cross-match were negative, patients were transplanted and received post-transplant desensitization with rituximab, apheresis and immunoglobulins.* From June 2022 to February 2023, we delisted HLA-antigens from 14 patients in the waiting list with a cPRA=100% who had waited in the prioritization Spanish program (PATHI) for a median time of 5.8[4.6-9.1] years...Only one patient had a positive FC-XM and was desensitized before transplantation with imlifidase and discarded from the analysis... Since DSA are not invariably associated with early graft failure due to rejection, delisting strategy and post-transplant desensitization may be considered for hypersensitized transplant candidates with 100% cPRA who have not any other options of finding a compatible match.
  • ||||||||||  Idefirix (imlifidase) / Hansa Biopharma, Sarepta Therap
    Long-Term Follow Up of Imlifidase Desensitized Kidney Transplant Recipients: 5 Year Pooled Analysis (108-AB, Level 1) -  May 6, 2024 - Abstract #ATC2024ATC_2895;    
    Since DSA are not invariably associated with early graft failure due to rejection, delisting strategy and post-transplant desensitization may be considered for hypersensitized transplant candidates with 100% cPRA who have not any other options of finding a compatible match. At 5 years, XM+ imlifidase enabled transplant recipients continue to demonstrate expected patient and graft survival and despite the high-risk immunological profile of these patients, the relative stability of allograft function indicates imlifidase is a viable treatment option for patients whose breadth and depth of sensitization may preclude them from receiving a compatible transplant.
  • ||||||||||  Idefirix (imlifidase) / Hansa Biopharma, Sarepta Therap
    IgM Cleaving Enzyme on Anti-Pig Xenoreative IgM and IgG in Nonhuman Primate Model (114 - Nutter Theater, Level 1) -  May 6, 2024 - Abstract #ATC2024ATC_2446;    
    Repeat administration of IceM in macaques enables selective, robust and transient (or prolonged) clearance of circulating IgM. This approach will be useful in treating preformed natural IgM and rebound IgM during antibody-mediated rejection in xenotransplantation.
  • ||||||||||  Thymoglobulin (anti-thymocyte globulin (rabbit)) / Sanofi, Idefirix (imlifidase) / Hansa Biopharma, Sarepta Therap
    A Phase II Study Investigating DSA Rebound in Highly Sensitized Living Donor Kidney Transplant Recipients Treated with Imlifidase (107-AB, Level 1) -  May 6, 2024 - Abstract #ATC2024ATC_1767;    
    Imlifidase is effective at converting a positive crossmatch to negative, enabling living donor kidney transplantation in highly sensitized patients who were previously unable to be transplanted with other modalities with substantial time in paired exchange. The proposed desensitization regimen appears safe and effective at suppressing DSA rebound and reducing the risk of early AMR.
  • ||||||||||  Thymoglobulin (anti-thymocyte globulin (rabbit)) / Sanofi
    Low Molecular Evolution of SARS-CoV-2 in Kidney Transplant Recipients (118-ABC, Level 1) -  May 6, 2024 - Abstract #ATC2024ATC_1192;    
    CDC guidelines recommending 20 days of isolation in immunosuppressed individuals seems to be too conservative for most KTR, with the exception of those within 1 year after transplantation, receiving T-cell depletive induction. There were no warning signals of molecular evolution and all KTRs cleared the virus, including those with high immunosuppressive burden such as imlifidase treatment.
  • ||||||||||  Idefirix (imlifidase) / Hansa Biopharma, Sarepta Therap
    Reestablishment of COVID-Specific IgG Antibodies after Imlifidase Treatment (Poster Hall, Exhibit Hall A, Level 2) -  May 6, 2024 - Abstract #ATC2024ATC_911;    
    However, it should be noted that other components of the immune system such as IgM and IgD are left intact and able to respond to active infection during imlifidase treatment. This was highlighted by the subject who was infected with COVID during the study.
  • ||||||||||  Idefirix (imlifidase) / Hansa Biopharma, Sarepta Therap
    IgG depletion with imlifidase ? a potential way to increase the eligible patient population for AAV based gene therapies () -  Oct 15, 2023 - Abstract #ESGCT2023ESGCT_1051;    
    All in all, antibody depletion with imlifidase could be a solution for patients excluded from participation in gene therapy clinical trials because of pre?formed immunogenicity towards the AAV vector. The therapeutic potential of imlifidase as pre?treatment to gene therapy is currently being evaluated for AAV based gene therapies in collaboration with Sarepta Therapeutics, Genethon and AskBio.*EU/EEA, UK and Switzerland
  • ||||||||||  Idefirix (imlifidase) / Hansa Biopharma, Sarepta Therap
    Neutralizing Antibody Depletion with Imlifidase - A Potential Way to Enable AAV Based Gene Therapy in Seropositive Patients (Board No. 726) -  Apr 21, 2023 - Abstract #ASGCT2023ASGCT_1358;    
    All in all, antibody depletion with imlifidase could offer a simple and elegant way to enable gene therapy in seropositive patients with AAV antibodies and supports the rational for further clinical studies. The therapeutic effects of imlifidase established in various indications are thus being further evaluated in AAV based gene therapy in collaboration with gene therapy companies, including Sarepta Therapeutics and AskBio.*EU/EEA, UK and Switzerland
  • ||||||||||  Idefirix (imlifidase) / Hansa Biopharma, Sarepta Therap
    Enrollment change, Trial completion date, Trial termination, Trial primary completion date:  An Long-term Follow-up Trial of Kidney Tx Patients Treated With Imlifidase or PE After an AMR (clinicaltrials.gov) -  Apr 6, 2023   
    P=N/A,  N=18, Terminated, 
    The therapeutic effects of imlifidase established in various indications are thus being further evaluated in AAV based gene therapy in collaboration with gene therapy companies, including Sarepta Therapeutics and AskBio.*EU/EEA, UK and Switzerland N=30 --> 18 | Trial completion date: Apr 2025 --> Mar 2023 | Recruiting --> Terminated | Trial primary completion date: Apr 2025 --> Mar 2023; This is an internal decision based on prioritisations and no safety issues have been raised during the trial.
  • ||||||||||  Idefirix (imlifidase) / Hansa Biopharma, Sarepta Therap
    Trial completion, Trial completion date:  An Efficacy and Safety Study of Imlifidase in Treatment of Antibody-Mediated Rejection in Kidney Transplant Patients (clinicaltrials.gov) -  Feb 28, 2023   
    P2,  N=30, Completed, 
    N=30 --> 18 | Trial completion date: Apr 2025 --> Mar 2023 | Recruiting --> Terminated | Trial primary completion date: Apr 2025 --> Mar 2023; This is an internal decision based on prioritisations and no safety issues have been raised during the trial. Active, not recruiting --> Completed | Trial completion date: Mar 2023 --> Nov 2022
  • ||||||||||  Idefirix (imlifidase) / Hansa Biopharma, Sarepta Therap, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
    Successful Desensitization of Severe Alloimmune Platelet Refractoriness and Provision of Permissive Platelet Transfusions with a Novel IgG-Targeted Enzyme Therapeutic (ENMCC - Hall D) -  Nov 4, 2022 - Abstract #ASH2022ASH_5639;    
    PATIENT CASE A 43-year-old woman with AML treated with cytarabine and daunorubicin was referred for matched-unrelated donor allogeneic hematopoietic progenitor cell transplantation...STUDY DESIGN With IRB approval, the number of predicted clinically significant alloantibodies (antibodies with = 3000 mean fluorescence intensity, MFI) and PRA (LABScreen single antigen and PRA Class I, One Lambda/ThermoFisher, West Hills, California) were compared at baseline, after rituximab/TPE, and after imlifidase administration...Our limited data suggest a potentially novel application of imlifidase for desensitization of highly platelet allo-refractory patients requiring multiple platelet transfusions over a short period. We will perform western blot analysis of antibodies from in vivo samples collected over the treatment course to compare antibody fragmentation over time, as partially cleaved immunoglobulin detected by our microbead-based assays may not be pathologic.2 Additionally, as the patient’s initial antibody levels exceeded the range of linearity of the bead-based assay, serial dilution studies of patient serum over the treatment course will more precisely semi-quantitate the true peak antibody levels.
  • ||||||||||  Idefirix (imlifidase) / Hansa Biopharma, Sarepta Therap
    Erythrocyte Targeted Ides Selectively Cleaves RBC-Bound Antibodies and Protects Against IgG Mediated Hemolysis (Orange County Convention Center - Tangerine Ballroom 1) -  Sep 26, 2022 - Abstract #AABB2022AABB_505;    
    Fab-IdeS fusion proteins bind to the erythrocyte surface improving pharmacokinetics, enhancing selectivity for RBC-bound IgG, and increasing potency in a murine passive immunization model. Further investigation is warranted to determine their potential as translational therapeutics for treatment of IgG-mediated hemolysis in clinical settings.
  • ||||||||||  Idefirix (imlifidase) / Hansa Biopharma, Sarepta Therap
    Trial completion date, Trial initiation date, Trial primary completion date:  A Study to Investigate DSA Rebound in Patients Treated with Imlifidase Prior to Transplantation (clinicaltrials.gov) -  Aug 24, 2022   
    P2,  N=12, Not yet recruiting, 
    Further investigation is warranted to determine their potential as translational therapeutics for treatment of IgG-mediated hemolysis in clinical settings. Trial completion date: Jun 2023 --> Jun 2024 | Initiation date: Oct 2021 --> Oct 2022 | Trial primary completion date: Mar 2023 --> Mar 2024