Invivyd's COVID-19 Antibody Shows Favorable Safety, Tolerability Profile For Immunocompromised People

Invivyd Inc IVVD announced additional initial data from its ongoing Phase 1 healthy volunteer clinical trial of its lead investigational monoclonal antibody (mAb) candidate, VYD222. 

VYD222 is a broadly neutralizing, half-life extended mAb candidate in development for the prevention of symptomatic COVID-19 in vulnerable populations, such as immunocompromised people.

Related: Invivyd Says Investigational Antibody Shows Potential To Prevent Symptomatic COVID-19.

The Phase 1 trial of VYD222 enrolled 30 healthy volunteers across three different dosing cohorts. 

The initial Phase 1 data showed that a single administration of VYD222 was generally well-tolerated at all three dose levels tested, with no serious adverse events (SAEs) reported to date. 

At the middle VYD222 dose tested (2500 mg), geometric mean serum neutralizing titers were 9647.0 against Omicron XBB.1.5 at Day 7, with a geometric mean 92.82-fold rise from baseline to Day 7. 

At the highest VYD222 dose tested (4500 mg), geometric mean serum neutralizing titers were 16864.7, with a geometric mean 120.97-fold rise. 

The higher VYD222 dose levels tested in the Phase 1 clinical trial are designed to provide additional protection from potential loss of neutralization activity as SARS-CoV-2 evolves over time.

Analysis of the serum-neutralizing activity from samples collected at different time points across all dose cohorts in the Phase 1 clinical trial is ongoing, as is detailed pharmacokinetic analysis and modeling. 

Invivyd intends to use these analyses, combined with published clinical outcome data from prior clinical trials of vaccines and mAbs for the prevention of symptomatic COVID-19, including data from its Phase 2/3 clinical trial of adintrevimab for the prevention of COVID-19 (EVADE), to further inform its VYD222 dosing strategy.

Price Action: IVVD shares are up 1.44% at $1.41 on the last check Monday.