Business
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
Recruitment completed and all doses administered for VYD2311 ongoing Phase 1/2 clinical trial (40 subjects) evaluating 3 routes of administrationPhase 1/2
About this update from Invivyd, Inc.
[{"type":"text","content":"Recruitment completed and all doses administered for VYD2311 ongoing Phase 1/2 clinical trial (40 subjects) evaluating 3 routes of administrationPhase 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 reactionsAs of Day 65, serum concentrations remain high with half-life not yet reached, indicating potential long clinical dosing intervalIn 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 diseaseLess frequent (e.g. once- or twice-annual) intramuscular or subcutaneous dosingMore 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 WALTHAM, Mass., Feb. 03, 2025 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD) today announced positive data from its ongoing Phase 1/2 clinical trial of VYD2311, Invivyd's novel monoclonal antibody (mAb) candidate designed to be a superior alternative to COVID-19 vaccination for the broad population as frontline protection in a convenient form, as well as to provide a novel, potent, long-acting option for the treatment of COVID-19. COVID-19 in 2024 caused approximately 59,0001 deaths, 665,0001 hospitalizations, and growing burden of Long COVID over time, despite broadly available and utilized vaccine boosts and small molecule therapy. The initial Phase 1/2 data support VYD2311's potential as a more effective and convenient option to manage this deadly disease. Invivyd's ongoing randomized, double-blind, Phase 1/2 clinical trial is evaluating the safety and clinical pharmacokinetic (PK) profile of VY...