Invivyd, Inc. (Nasdaq: IVVD) has announced positive initial data from its Phase 1/2 clinical trial of VYD2311, a novel monoclonal antibody (mAb) candidate designed as a superior alternative to COVID-19 vaccination. The trial aims to assess VYD2311's potential for broad population frontline protection and as a potent, long-acting treatment for COVID-19.
The Phase 1/2 trial, which has completed recruitment and dosing of all 40 subjects, evaluates three routes of administration: intravenous (IV), intramuscular (IM), and subcutaneous (SC). The initial data indicate a positive safety and pharmacokinetic profile for VYD2311, supported by antiviral activity data from Invivyd's virologic assessments.
Key Findings from the Phase 1/2 Trial
- Safety and Tolerability: Pooled, blinded adverse events (AEs) to date are mild to moderate, primarily injection site or infusion reactions, and deemed unrelated to the study drug.
- Pharmacokinetics: As of Day 65, serum concentrations remain high, with the half-life not yet reached, suggesting a potential for long clinical dosing intervals. The IM cohort's analysis aligns with the pharmacokinetic profile of adintrevimab, a previous Invivyd mAb with an estimated in vivo half-life of 139 days.
- In Vitro Potency: VYD2311 demonstrates an average 17-fold greater neutralization potency than pemivibart across contemporary SARS-CoV-2 variants tested.
Potential Clinical Profile
The combined Phase 1/2 clinical data, antiviral assessments, and COVID-19 antiviral correlate of protection data, including Invivyd's Phase 3 CANOPY trial data for pemivibart, suggest a promising clinical profile for VYD2311. This includes:
- Stronger protection (70-90%) from symptomatic COVID-19 disease.
- Less frequent (once- or twice-annual) intramuscular or subcutaneous dosing.
- More favorable safety and tolerability, without activating the subject's immune system.
Strategic Implications
Marc Elia, Chairman of Invivyd's Board of Directors, stated, "We are thrilled with these Phase 1/2 data for VYD2311, which we designed for the profile we are seeing so far: a potent and long-lasting mAb with the potential to protect people with none of the well-understood limitations of COVID-19 vaccination." He added that Invivyd aims to collaborate with the U.S. FDA to advance VYD2311 to populations at the highest risk of COVID-19.
Tim Lee, Chief Commercial Officer of Invivyd, highlighted the significant impact of COVID-19, noting that in the past year, more Americans died from COVID-19 than breast cancer. He emphasized the potential of VYD2311 to offer a more convenient, scalable, and effective alternative to current vaccine boosts.
About VYD2311
VYD2311 is engineered using Invivyd's technology, involving directed evolution of antibodies for higher potency against contemporary SARS-CoV-2 lineages. It shares a similar epitope with pemivibart and adintrevimab, which has remained genetically stable across numerous virus variants.
COVID-19 Burden and Current Landscape
Despite available vaccines and small molecule therapies, COVID-19 caused approximately 59,000 deaths and 665,000 hospitalizations in 2024, with a growing burden of Long COVID. VYD2311 aims to address the need for more effective and convenient options to manage this disease.
