birtamimab (NEOD001) / Prothena 
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 3 Diseases   2 Trials   2 Trials   129 News 


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  • ||||||||||  birtamimab (NEOD001) / Prothena, Darzalex (daratumumab) / J&J, anselamimab (CAEL-101) / AstraZeneca
    Review, Journal:  Novel monoclonal antibodies: A really specific therapy for light chain amyloidosis. (Pubmed Central) -  Apr 13, 2024   
    However, current clinical studies are investigating innovative targets, drug combinations and treatment strategies to improve therapeutic outcomes by minimizing adverse effects and refining patient prognosis in these challenging hematological conditions. In this paper, we review the state of the art regarding the use of anti-amyloid antibodies, as a revolutionary and innovative approach in the current scenario of amyloid treatment.
  • ||||||||||  birtamimab (NEOD001) / Prothena
    SURVIVAL BENEFIT OF BIRTAMIMAB IN MAYO STAGE IV AL AMYLOIDOSIS IN THE PHASE 3 VITAL STUDY WAS CONSISTENT ACROSS ALL KEY BASELINE VARIABLES (Poster Area) -  Apr 4, 2023 - Abstract #EMN2023EMN_202;    
    P3
    The survival benefit of birtamimab was consistent across all key baseline variables, including demographic factors (age, sex, race, ethnicity), clinical characteristics (age at diagnosis, duration since diagnosis, NYHA class, 6MWT distance), and laboratory parameters (NT-proBNP, dFLC, FLC, troponin-T), reinforcing the strength of the survival data in Mayo Stage IV pts. The AFFIRM-AL study (NCT04973137), designed to confirm the VITAL study results in Mayo Stage IV AL amyloidosis pts, is currently being conducted under a Special Protocol Assessment agreement with the US FDA with ?=0.10 for the primary endpoint of ACM.
  • ||||||||||  birtamimab (NEOD001) / Prothena, Darzalex (daratumumab) / J&J, anselamimab (CAEL-101) / AstraZeneca
    Review, Journal:  Advancements and future trends of immunotherapy in light-chain amyloidosis. (Pubmed Central) -  Mar 2, 2023   
    This was met with promising results for CAEL-101 and birtamimab. Although still in early stages, novel treatment options in pipeline, including antibody-drug conjugates, bispecific T-cell engagers, and chimeric antigen receptor T cell therapy may diversify the treatment armamentarium of AL amyloidosis in the future.
  • ||||||||||  birtamimab (NEOD001) / Prothena, Darzalex (daratumumab) / J&J, anselamimab (CAEL-101) / AstraZeneca
    Efficacy and Safety of Anti-Amyloid Antibodies in Patients with AL Amyloidosis: A Systematic Review of Literature () -  Nov 29, 2022 - Abstract #ASH2022ASH_7721;    
    P1, P2, P3
    13 pts with Mayo Stage (MS) IIIA/B AL amyloidosis received CAEL-101+standard of care (SoC) cyclophosphamide-bortezomib-dexamethasone (CyBorD)...Rx A and B involved 9 and 10 pts who received Daratumumab(Dara)+NEOD001 vs Dara alone respectively...2 pts with Dara experienced respiratory symptoms.Anti-SAP Antibody:Trials for Anti-SAP Ab are either completed with non-satisfactory results or terminated owing to the change in risk/benefit profile by certain data (NCT01777243, NCT03044353).Conclusion :CAEL-101 and NEOD001 are novel therapies for advanced AL amyloidosis with mild to moderate TEAEs. The ongoing trials need a longer follow-up to further elucidate the safety and efficacy of AA-Ab (Table1).
  • ||||||||||  birtamimab (NEOD001) / Prothena
    C11-1F4 Binds and Promotes Clearance of Light Chain Fibrils By Phagocytosis () -  Nov 29, 2022 - Abstract #ASH2022ASH_7640;    
    THP-1 derived macrophages were treated with C11-1F4, IgG-1 isotype control (NIST), or NEOD-001 at various concentrations preincubated with 1uM of pHrodo™Red-labeled-AL-09 fibrils...To confirm our observation from whole blood assay, we conducted the phagocytosis assay on isolated PMN cells. C11-1F4 significantly induces internalization of the pHrodo™Red-conjugated AL-09 fibrils by PMN cells compared to the isotype control antibody (Figure 2).In conclusion, our studies highlight the role of C11-1F4 in fibril opsonization and recruitment of immune cells leading to fibril removal.
  • ||||||||||  birtamimab (NEOD001) / Prothena
    Survival Benefit of Birtamimab in Mayo Stage IV AL Amyloidosis in the Phase 3 VITAL Study Consistent after Adjustment for Key Baseline Variables (ENMCC - 288-290) -  Nov 4, 2022 - Abstract #ASH2022ASH_5115;    
    P3
    The survival benefit of birtamimab was consistent across all key baseline variables, including demographic factors (age, sex, race, ethnicity), clinical characteristics (age at diagnosis, duration since diagnosis, NYHA class, 6MWT distance), and laboratory parameters (NT-proBNP, dFLC, FLC, troponin-T), reinforcing the strength of the survival data in Mayo Stage IV patients. The AFFIRM-AL study, designed to confirm the VITAL study results in Mayo Stage IV AL amyloidosis patients, is currently active and enrolling.
  • ||||||||||  birtamimab (NEOD001) / Prothena, Darzalex (daratumumab) / J&J, anselamimab (CAEL-101) / AstraZeneca
    Review, Journal:  Multidisciplinary supportive care in systemic light chain amyloidosis. (Pubmed Central) -  May 21, 2022   
    Now with the approval of highly tolerable anti-CD38 monoclonal antibody daratumumab based anti-plasma cell therapy in 2021, high rates of hematologic complete responses are possible even in patients who are otherwise deemed not a candidate for autologous stem cell transplantation...In addition to achieving excellent anti-plasma cell disease control, using treatment directed to remove amyloid from the vital organs can theoretically hasten recovery of the involved organs thereby improving symptoms at a faster pace. Ongoing phase III clinical trials of CAEL-101 and Birtamimab will address this question.
  • ||||||||||  birtamimab (NEOD001) / Prothena
    Birtamimab in patients with Mayo stage IV AL amyloidosis: Rationale for confirmatory affirm-AL phase 3 study. (Available On Demand; 495a) -  Apr 28, 2022 - Abstract #ASCO2022ASCO_4188;    
    P3
    Treatments that improve survival in AL amyloidosis are needed, particularly for patients with advanced cardiac involvement, as median overall survival for those with Mayo Stage IV disease is ̃6–9 months. The AFFIRM-AL study is designed to confirm the survival benefit observed in the VITAL study in patients with Mayo Stage IV AL amyloidosis.
  • ||||||||||  birtamimab (NEOD001) / Prothena
    Birtamimab in Patients with Mayo Stage IV AL Amyloidosis: Rationale for Confirmatory Affirm-AL Phase 3 Study Design (GWCC - Hall B5, Level 1) -  Nov 5, 2021 - Abstract #ASH2021ASH_4396;    
    P3
    Conclusion/Summary: Effective treatments to improve survival in AL amyloidosis are needed, particularly for patients with advanced cardiac involvement, as median overall survival for those with Mayo stage IV disease is approximately 6-9 months. Birtamimab is the only investigational therapeutic in which a survival benefit has been observed, in a post hoc subgroup analysis of VITAL in patients with AL amyloidosis with advanced cardiac involvement.
  • ||||||||||  birtamimab (NEOD001) / Prothena, Darzalex IV (daratumumab) / J&J
    [VIRTUAL] COMBINING ANTI-FIBRIL ANTIBODY NEOD001 WITH ANTI-CD38 ANTIBODY DARATUMUMAB IN SYSTEMIC LIGHT-CHAIN AMYLOIDOSIS () -  Mar 27, 2021 - Abstract #ISOA2020ISOA_367;    
    P2b, P3
    In 9 AL patients with cardiac involvement in this series of 19 patients, we combined two monoclonal antibodies safely without unexpected toxicities, encouraging future combinations of monoclonals in this population. High rates of hematologic and organ responses occurred at a rapid pace with the combination of dara and D1, suggesting possible synergistic activity that requires further validation in a prospective randomized study.
  • ||||||||||  Darzalex IV (daratumumab) / J&J
    Review, Journal, IO biomarker:  Beyond Andromeda: Improving Therapy for Light Chain Amyloidosis. (Pubmed Central) -  Feb 23, 2021   
    P3
    Though depth and kinetics of achieving deep hematologic response as well as rates of biomarker defined organ response were improved with the addition of daratumumab to the combination of bortezomib, cyclophosphamide, and dexamethasone, death rates in each arm remained similar...We also look ahead to efforts to reimagine the clinical development of anti-fibrillar therapies after late phase study failures. Upcoming anti-amyloid fibril antibody studies explore opportunities to improve outcomes for the sickest AL patients with advanced cardiac disease, focusing on improving overall patient survival and reducing the risk of early death in this uniquely frail population.