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Invivyd Announces Additional Positive Initial Data from Ongoing Phase 1 Clinical Trial of VYD222, a Monoclonal Antibody Candidate in Development for the Prevention of Symptomatic COVID-19 in Immunocompromised People
Continued favorable safety and tolerability profile for all dose levels testedSerum samples from all dose levels tested showed robust neutralization activity
About this update from Invivyd, Inc.
[{"type":"text","content":"Continued favorable safety and tolerability profile for all dose levels testedSerum samples from all dose levels tested showed robust neutralization activity against Omicron XBB.1.5, one of the dominant SARS-CoV-2 variants circulating globallyOngoing analysis of serum neutralizing activity and pharmacokinetic data expected to support rapid anticipated transition to pivotal clinical trial WALTHAM, Mass., July 17, 2023 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a clinical-stage biopharmaceutical company on a mission to protect the vulnerable from serious viral infectious diseases, today announced additional positive 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. The Phase 1 clinical trial of VYD222 enrolled 30 healthy volunteers across three different dosing cohorts. In each cohort, participants were randomized 8:2 to VYD222 or placebo. 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 (95% CI: 6115.4, 15218.0) against Omicron XBB.1.5 at Day 7, with a geometric mean 92.82-fold rise (95% CI: 21.2, 406.6) from baseline to Day 7. At the highest VYD222 dose tested (4500 mg), geometric mean serum neutralizing titers were 16864.7 (95% CI: 12825.5, 22176.1) against Omicron XBB.1.5 at Day 7, with a geometric mean 120.97-fold rise (95% CI: 31.4, 466.2) from baseline to Day 7. 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. The results announced today add to the positive initial Phase 1 data reported in June 2023, which showed that the lowest VYD222 dose tested (1500 mg) resulted in geometric mean serum neutralizing titers of 3245.1 (95% CI: 1882.5, 5594.0) against Omicron XBB.1.5 at Day 7, with a geometric mean 38.87-fold rise (95% CI: 10.3, 146.8) from baseline to Day 7. Analysis o...