Loargys (pegzilarginase) / Immedica 
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 0 Diseases   4 Trials   4 Trials   17 News 


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  • ||||||||||  Loargys (pegzilarginase) / Immedica
    Enrollment open:  Pegzilarginase in Subjects <24 Months Old With Arginase 1 Deficiency (clinicaltrials.gov) -  Sep 19, 2024   
    P3,  N=3, Recruiting, 
    Current management strategies are insufficient for preventing progression, highlighting the need for innovative treatments like enzyme replacement and gene therapy. Not yet recruiting --> Recruiting
  • ||||||||||  Loargys (pegzilarginase) / Immedica
    EXPERIENCE OF PEGZILARGINASE FOR THE TREATMENT OF ARGINASE 1 DEFICIENCY OUTSIDE CLINICAL TRIAL SETTING (Poster Room | Level 0) -  Jul 30, 2024 - Abstract #SSIEM2024SSIEM_843;    
    Samples collected in nor-NOHA tubes are stable up to 14 days at room temperature. Data collected confirm the biochemical results demonstrated in the clinical trial setting, with further indications of opportunities for diet liberalization in ARG1-D with pegzilarginase treatment.
  • ||||||||||  Loargys (pegzilarginase) / Immedica
    Meeting the Unmet Need: Introducing pegzilarginase for the treatment of Arginase 1 Deficiency (Magnolia Auditorium | Level -1) -  Jun 13, 2024 - Abstract #SSIEM2024SSIEM_63;    
    After a brief introduction to the disease including prevalence, main signs and symptoms and current standard of care, a presentation on the disease pathophysiology will follow to highlight the role of arginine and its metabolites in the disease progression. Finally, the Phase III clinical trial results of pegzilarginase for the treatment of ARG1-D leading to EMA approval in December 2023 and clinical experience outside clinical trial setting will be presented.
  • ||||||||||  Loargys (pegzilarginase) / Immedica
    Enrollment change, Trial completion date, Trial initiation date, Trial termination, Trial primary completion date:  A Study of Safety of Weekly Subcutaneous Pegzilarginase in Subjects With Arginase 1 Deficiency (clinicaltrials.gov) -  Jul 28, 2023   
    P3,  N=3, Terminated, 
    Aeglea BioTherapeutics. N=48 --> 3 | Trial completion date: May 2024 --> Apr 2023 | Initiation date: Jan 2023 --> Apr 2023 | Not yet recruiting --> Terminated | Trial primary completion date: May 2024 --> Apr 2023; Sponsor Decision
  • ||||||||||  Loargys (pegzilarginase) / Immedica
    Trial completion, Trial completion date, Trial primary completion date:  Efficacy and Safety of Pegzilarginase in Patients With Arginase 1 Deficiency (clinicaltrials.gov) -  Jul 27, 2023   
    P3,  N=32, Completed, 
    N=48 --> 3 | Trial completion date: May 2024 --> Apr 2023 | Initiation date: Jan 2023 --> Apr 2023 | Not yet recruiting --> Terminated | Trial primary completion date: May 2024 --> Apr 2023; Sponsor Decision Active, not recruiting --> Completed | Trial completion date: Feb 2025 --> Jan 2023 | Trial primary completion date: Aug 2024 --> Jan 2023
  • ||||||||||  Loargys (pegzilarginase) / Immedica
    Trial completion, Trial completion date, Trial primary completion date:  CAEB1102-102A: A Study of AEB1102 (Pegzilarginase) in Patients With Arginase I Deficiency (clinicaltrials.gov) -  Jul 27, 2023   
    P2,  N=14, Completed, 
    Active, not recruiting --> Completed | Trial completion date: Feb 2025 --> Jan 2023 | Trial primary completion date: Aug 2024 --> Jan 2023 Active, not recruiting --> Completed | Trial completion date: Jun 2023 --> Dec 2022 | Trial primary completion date: Jun 2023 --> Dec 2022
  • ||||||||||  pegylated recombinant human arginase (BCT-100) / BCT international, pegzilarginase (AEB1102) / Aeglea, Hepacid (pegargiminase) / Polaris Pharma
    Review, Journal, PD(L)-1 Biomarker, IO biomarker:  Arginine Deprivation in SCLC: Mechanisms and Perspectives for Therapy. (Pubmed Central) -  Sep 14, 2022   
    Moreover, recent work has identified an intriguing role for targeting arginine in combination with PD-1/PD-L1 immune checkpoint inhibitors and clinical trials are in progress. Thus, future studies of arginine-depleting agents with chemoimmunotherapy, the current standard of care for SCLC, may lead to enhanced disease control and much needed improvements in long-term survival for patients.
  • ||||||||||  Loargys (pegzilarginase) / Immedica
    Trial completion date, Trial primary completion date:  CAEB1102-102A: A Study of AEB1102 (Pegzilarginase) in Patients With Arginase I Deficiency (clinicaltrials.gov) -  Jul 25, 2022   
    P2,  N=14, Active, not recruiting, 
    Thus, future studies of arginine-depleting agents with chemoimmunotherapy, the current standard of care for SCLC, may lead to enhanced disease control and much needed improvements in long-term survival for patients. Trial completion date: Jun 2022 --> Jun 2023 | Trial primary completion date: Jun 2022 --> Jun 2023
  • ||||||||||  pegzilarginase (AEB1102) / Aeglea
    Review, Journal:  Natural history of arginase 1 deficiency and the unmet needs of patients: A systematic review of case reports. (Pubmed Central) -  Jul 14, 2022   
    Author-reported clinical improvement was documented for 26% of patients, 15% deteriorated, and 19% had limited or no change; notably, no indication of clinical outcome was reported for 40% cases. This review illustrates a significant burden of disease and highlights a considerable unmet need for clinically effective treatment options for patients with ARG1-D.
  • ||||||||||  Loargys (pegzilarginase) / Immedica
    Trial completion date, Trial primary completion date:  Efficacy and Safety of Pegzilarginase in Patients With Arginase 1 Deficiency (clinicaltrials.gov) -  Mar 28, 2022   
    P3,  N=32, Active, not recruiting, 
    This review illustrates a significant burden of disease and highlights a considerable unmet need for clinically effective treatment options for patients with ARG1-D. Trial completion date: Jul 2024 --> Feb 2025 | Trial primary completion date: Sep 2022 --> Aug 2024
  • ||||||||||  pegzilarginase (AEB1102) / Aeglea
    Clinical, Journal:  Clinical Effect and Safety Profile of Pegzilarginase In Patients with Arginase-1 Deficiency. (Pubmed Central) -  Jan 18, 2022   
    Pegzilarginase was effective in lowering pArg levels with an accompanying clinical response in patients with ARG1-D. The improvements with pegzilarginase occurred in patients receiving standard treatment approaches, which suggests that pegzilarginase could offer benefit over existing disease management.
  • ||||||||||  pegzilarginase (AEB1102) / Aeglea
    Journal, Checkpoint inhibition, PD(L)-1 Biomarker, IO biomarker:  Arginase therapy combines effectively with checkpoint blockade or agonist anti-OX40 immunotherapy to control tumor growth. (Pubmed Central) -  Dec 1, 2021   
    Our data suggests potential mechanisms of synergy between pegzilarginase and I-O agents that include increased intratumoral MHC expression on both APCs and tumor cells, and increased presence of M1-like anti-tumor macrophages. These data support the clinical evaluation of I-O agents in conjunction with pegzilarginase for the treatment of patients with cancer.
  • ||||||||||  Loargys (pegzilarginase) / Immedica
    Trial primary completion date:  Efficacy and Safety of Pegzilarginase in Patients With Arginase 1 Deficiency (clinicaltrials.gov) -  Oct 12, 2021   
    P3,  N=32, Active, not recruiting, 
    These data support the clinical evaluation of I-O agents in conjunction with pegzilarginase for the treatment of patients with cancer. Trial primary completion date: Sep 2021 --> Sep 2022
  • ||||||||||  Loargys (pegzilarginase) / Immedica
    Trial completion date, Trial primary completion date:  Efficacy and Safety of Pegzilarginase in Patients With Arginase 1 Deficiency (clinicaltrials.gov) -  Mar 24, 2021   
    P3,  N=30, Recruiting, 
    Recruiting --> Active, not recruiting Trial completion date: Jun 2023 --> Jul 2024 | Trial primary completion date: Mar 2021 --> Sep 2021
  • ||||||||||  Loargys (pegzilarginase) / Immedica
    Trial completion date, Trial primary completion date:  CAEB1102-102A: A Study of AEB1102 (Pegzilarginase) in Patients With Arginase I Deficiency (clinicaltrials.gov) -  Jan 13, 2021   
    P2,  N=14, Active, not recruiting, 
    Active, not recruiting --> Completed Trial completion date: Jun 2021 --> Jun 2022 | Trial primary completion date: Jun 2021 --> Jun 2022
  • ||||||||||  pegzilarginase (AEB1102) / Aeglea
    [VIRTUAL] Developing Novel Combinations to Enhance the Therapeutic Efficacy of OX40 Agonists () -  Aug 31, 2020 - Abstract #PEGS2020PEGS_294;    
    Therefore, we investigated the efficacy of combined therapy with pegzilarginase, a human arginase 1 enzyme engineered to have superior stability and enzymatic activity relative to native human arginase 1, plus anti-PD-L1 or agonist anti-OX40 mAb. Combined pegzilarginase/immunotherapy induced robust anti-tumor immunity characterized by increased intratumoral CD8+ T cells and M1-polarization of tumor-associated macrophages and provides a strong rationale for clinical translation of this approach.
  • ||||||||||  pegzilarginase (AEB1102) / Aeglea
    [VIRTUAL] Aeglea () -  Jun 9, 2020 - Abstract #BIO2020BIO_85;    
    In building on our metabolic franchise, we intend to file an IND or CTA for our second program for the treatment of Homocystinuria in the first quarter of 2020. Additionally, we are continuing IND-enabling activities for our Cystinuria program, where we intend to enter the clinic in 2020.
  • ||||||||||  pegzilarginase (AEB1102) / Aeglea
    ¬Arginase therapy combines effectively with checkpoint blockade or agonist anti-OX40 immunotherapy to control tumor growth (Prince George's Exhibition Halls AB) -  Oct 2, 2019 - Abstract #SITC2019SITC_865;    
    Our data suggests two potential mechanisms of synergy between pegzilarginase and I-O agents: 1) Increased intratumoral MHC expression on APCs and tumor antigen presentation; and 2) Increased presence of M1-like anti-tumor macrophages. These data support the clinical evaluation of T cell agonists and/or checkpoint inhibitors in conjunction with pegzilarginase for the treatment of patients with cancer.
  • ||||||||||  Loargys (pegzilarginase) / Immedica
    Phase classification, Metastases:  A Multiple Dose, Dose Escalation Trial of AEB1102 in Patients With Advanced Solid Tumors (clinicaltrials.gov) -  Aug 19, 2019   
    P1/2,  N=98, Completed, 
    These data support the clinical evaluation of T cell agonists and/or checkpoint inhibitors in conjunction with pegzilarginase for the treatment of patients with cancer. Phase classification: P1 --> P1/2
  • ||||||||||  Loargys (pegzilarginase) / Immedica
    Trial completion date, Trial primary completion date, Metastases:  A Multiple Dose, Dose Escalation Trial of AEB1102 in Patients With Advanced Solid Tumors (clinicaltrials.gov) -  Dec 24, 2018   
    P1,  N=100, Recruiting, 
    Trial completion date: Dec 2019 --> Dec 2020 | Trial primary completion date: Dec 2019 --> Dec 2020 Trial completion date: Sep 2018 --> Jun 2019 | Trial primary completion date: Sep 2018 --> Jun 2019
  • ||||||||||  Loargys (pegzilarginase) / Immedica
    Enrollment closed, Enrollment change:  A Phase 1/2 Study of AEB1102 in Patients With Arginase I Deficiency (clinicaltrials.gov) -  Nov 13, 2018   
    P1/2,  N=16, Active, not recruiting, 
    Trial completion date: Sep 2018 --> Jun 2019 | Trial primary completion date: Sep 2018 --> Jun 2019 Recruiting --> Active, not recruiting | N=10 --> 16