Invivyd Inc IVVD announces initial data from its ongoing Phase 1 healthy volunteer clinical trial of VYD222, its investigational monoclonal antibody for COVID-19 prevention.
VYD222 is a broadly neutralizing, half-life extended mAb candidate in development to prevent symptomatic COVID-19 in vulnerable populations, such as immunocompromised people.
The company notes that as of June 2023, there are no monoclonal antibodies authorized or approved in the U.S. for the prevention of symptomatic COVID-19.
Single administration of VYD222 was well-tolerated, with no serious adverse events reported.
Geometric mean serum neutralizing titers show promising results against the Omicron variant.
At the lowest VYD222 dose tested (1500 mg), geometric mean serum neutralizing titers were 3245.1 against Omicron XBB.1.5 at Day 7, with a geometric mean 38.87-fold rise from baseline to Day 7.
Omicron XBB.1.5 and other related XBB sublineages are currently the dominant SARS-CoV-2 variants circulating globally.
VYD222 was designed for broad activity and has previously demonstrated in vitro neutralizing activity against prior circulating SARS-CoV-2 variants and current variants of concern, including Omicron sublineages up to and through XBB.1.5.
Higher VYD222 dose levels tested in the Phase 1 trial are designed to provide greater protection from any potential loss of neutralization activity as SARS-CoV-2 evolves.
Analysis of the serum-neutralizing activity from samples across all dose cohorts is ongoing, as is detailed pharmacokinetic analysis and modeling.
Price Action: IVVD shares are down 1.77% at $1.11 on the last check Thursday.
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