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  • ||||||||||  Evusheld (cilgavimab/tixagevimab) / AstraZeneca, adintrevimab (ADG20) / Invivyd, Biocon
    Journal:  COVID-19 update: An EUA for pemivibart (Pemgarda) for pre-exposure prophylaxis. (Pubmed Central) -  May 2, 2024   
    A single dose of VYD222 4500 mg IV was well tolerated in a subset of adult solid organ transplant recipients including those on active therapy post-transplant. No abstract available
  • ||||||||||  adintrevimab (ADG20) / Adagio Therap, Biocon
    Journal:  Antibody-mediated protection against symptomatic COVID-19 can be achieved at low serum neutralizing titers. (Pubmed Central) -  Mar 25, 2023   
    Extrapolation of adintrevimab pharmacokinetic data suggests that protection against susceptible variants could be maintained for about 3 years. The results provide a benchmark for the selection of next-generation vaccine candidates and support the use of broad, long-acting monoclonal antibodies as alternatives or supplements to vaccination in high-risk populations.
  • ||||||||||  adintrevimab (ADG20) / Adagio Therap, Biocon
    Preclinical, Journal:  Prophylactic Administration of the Monoclonal Antibody Adintrevimab Protects against SARS-CoV-2 in Hamster and Non-Human Primate Models of COVID-19. (Pubmed Central) -  Dec 16, 2022   
    Adintrevimab is a human immunoglobulin G1 monoclonal antibody engineered to have broad neutralization against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants and other SARS-like coronaviruses with pandemic potential. In both Syrian golden hamster and rhesus macaque models, prophylactic administration of a single dose of adintrevimab provided protection against SARS-CoV-2/WA1/2020 infection in a dose-dependent manner, as measured by significant reductions in lung viral load and virus-induced lung pathology, and by inhibition of viral replication in the upper and lower respiratory tract.
  • ||||||||||  adintrevimab (ADG20) / Invivyd, Biocon
    Trial completion date, Trial termination:  EVADE: Evaluation of ADG20 for the Prevention of COVID-19 (clinicaltrials.gov) -  Nov 29, 2022   
    P2/3,  N=5951, Terminated, 
    Trial completion date: Mar 2023 --> Nov 2022 | Active, not recruiting --> Terminated; All primary efficacy data has been collected and analyzed. Based on the safety data gathered to date, it has been determined that continued participation by study subjects would not yield any additional beneficial safety information.
  • ||||||||||  adintrevimab (ADG20) / Invivyd, Biocon
    Enrollment change, Trial completion date, Trial termination:  STAMP: Evaluation of ADG20 for the Treatment of Mild or Moderate COVID-19 (clinicaltrials.gov) -  Nov 29, 2022   
    P2/3,  N=417, Terminated, 
    N=1084 --> 417 | Trial completion date: Mar 2023 --> Nov 2022 | Active, not recruiting --> Terminated; All primary efficacy data has been collected and analyzed. Based on the safety data gathered to date, it has been determined that continued participation by study subjects would not yield any additional beneficial safety information.
  • ||||||||||  adintrevimab (ADG20) / Adagio Therap, Biocon
    Journal:  A broad and potent neutralization epitope in SARS-related coronaviruses. (Pubmed Central) -  Jul 7, 2022   
    Here, we show that therapeutic antibody ADG20 is able to neutralize SARS-CoV-2 variants of concern (VOCs) including Omicron (B.1.1.529) as well as other SARS-related coronaviruses...Importantly, antibodies that are able to target this site generally neutralize a broad range of VOCs, albeit with reduced potency against Omicron. Thus, this conserved and vulnerable site can be exploited for the design of universal vaccines and therapeutic antibodies.
  • ||||||||||  Evusheld (cilgavimab/tixagevimab) / AstraZeneca, ADG20 / Adagio Therap, Biocon
    Journal:  Insights on the mutational landscape of the SARS-CoV-2 Omicron variant receptor-binding domain. (Pubmed Central) -  Mar 12, 2022   
    Importantly, the AAI predicted escape resulting from indirect epitope perturbations was not captured by previous sequence or point mutation analyses. Finally, for several Omicron RBD mutations, we find evidence for a plausible role in enhanced transmissibility via disruption of RBD-down conformational stability at the RBD-RBD interface.
  • ||||||||||  adintrevimab (ADG20) / Invivyd, Biocon
    Enrollment closed:  STAMP: Evaluation of ADG20 for the Treatment of Mild or Moderate COVID-19 (clinicaltrials.gov) -  Jan 24, 2022   
    P2/3,  N=1084, Active, not recruiting, 
    Finally, for several Omicron RBD mutations, we find evidence for a plausible role in enhanced transmissibility via disruption of RBD-down conformational stability at the RBD-RBD interface. Recruiting --> Active, not recruiting
  • ||||||||||  adintrevimab (ADG20) / Invivyd, Biocon
    Enrollment closed:  EVADE: Evaluation of ADG20 for the Prevention of COVID-19 (clinicaltrials.gov) -  Jan 24, 2022   
    P2/3,  N=6412, Active, not recruiting, 
    Recruiting --> Active, not recruiting Recruiting --> Active, not recruiting
  • ||||||||||  adintrevimab (ADG20) / Invivyd, Biocon
    Enrollment open:  STAMP: Evaluation of ADG20 for the Treatment of Mild or Moderate COVID-19 (clinicaltrials.gov) -  Aug 22, 2021   
    P2/3,  N=1084, Recruiting, 
    Preliminary PK and sVNA titer profiles support the ongoing Phase 2/3 trials of ADG20 at a 300 mg IM dose for the prevention of COVID-19 (EVADE: NCT04859517) and treatment of ambulatory patients with mild to moderate COVID-19 (STAMP: NCT04805671). Not yet recruiting --> Recruiting
  • ||||||||||  adintrevimab (ADG20) / Invivyd, Biocon
    Enrollment change, Trial initiation date:  STAMP: Evaluation of ADG20 for the Treatment of Mild or Moderate COVID-19 (clinicaltrials.gov) -  May 24, 2021   
    P2/3,  N=1084, Not yet recruiting, 
    Not yet recruiting --> Recruiting N=1728 --> 1084 | Initiation date: Mar 2021 --> Jul 2021
  • ||||||||||  adintrevimab (ADG20) / Invivyd, Biocon
    Enrollment closed:  STAMP: Evaluation of ADG20 for the Treatment of Mild or Moderate COVID-19 (clinicaltrials.gov) -  Apr 28, 2021   
    P2/3,  N=1728, Active, not recruiting, 
    The unique, broadly neutralising activity of ADG20 highlights its potential to be an effective prophylactic and therapeutic agent against emergent variants of SARS-CoV-2 resistant to other clinical stage mAbs as well as pre-emergent SARS-like viruses with pandemic potential. Recruiting --> Active, not recruiting
  • ||||||||||  adintrevimab (ADG20) / Invivyd, Biocon
    Enrollment open:  EVADE: Evaluation of ADG20 for the Prevention of COVID-19 (clinicaltrials.gov) -  Apr 26, 2021   
    P2/3,  N=6412, Recruiting, 
    Recruiting --> Active, not recruiting Not yet recruiting --> Recruiting