Invivyd Positive Phase 1/2 Data for Monoclonal Antibody Designed to be Superior to COVID-19 Vax

 

• Recruitment completed and all doses administered for VYD2311 ongoing Phase 1/2 clinical trial (40 subjects) evaluating 3 routes of administration
• Phase 1/2 clinical data for VYD2311 to date are positive for both safety and pharmacokinetics, and are supported by antiviral activity data from Invivyd's standard virologic assessments
  • Pooled, blinded adverse events (AEs) to date are mild or moderate and thus far deemed unrelated to study drug or largely related to injection site reaction or infusion reactions
  • As of Day 65, serum concentrations remain high with half-life not yet reached, indicating potential long clinical dosing interval
  • In vitro neutralization potency of VYD2311 assessed across contemporary SARS-CoV-2 variants tested shows an average 17-fold greater neutralization potency than pemivibart
• Phase 1/2 clinical data, combined with antiviral assessment and COVID-19 antiviral correlate of protection data, including Invivyd's Phase 3 CANOPY clinical trial data for pemivibart, support a potential clinical profile for VYD2311 with superior efficacy, safety, and durability to COVID-19 vaccines:
  • Stronger protection (70-90%) from symptomatic COVID-19 disease
  • Less frequent (e.g. once- or twice-annual) intramuscular or subcutaneous dosing
  • More favorable safety and tolerability and, since VYD2311 is not a vaccine, no activation of subject immune systems
• Profile also suitable as a potential novel, potent, long-acting COVID-19 treatment option

https://www.globenewswire.com/news-release/2025/02/03/3019374/0/en/Invivyd-Announces-Positive-Phase-1-2-Clinical-Data-for-VYD2311-a-Monoclonal-Antibody-Designed-to-be-a-Superior-Alternative-to-COVID-19-Vaccination-for-the-Broad-Population.html