Invivyd VYD2311 meets Phase III endpoints as Declaration trial is delayed
- Invivyd’s monoclonal antibody candidate, VYD2311, met its co-primary endpoints in the Phase III LIBERTY study, demonstrating a superior safety and tolerability profile compared to the mRNA-based Comirnaty vaccine.
- In the LIBERTY trial (NCT07655180), researchers evaluated VYD2311 both as a standalone treatment and when co-administered with the Pfizer and BioNTech mRNA vaccine, Comirnaty.
- Beyond the initial six-day observation, VYD2311 maintained a favorable safety and tolerability profile over a 56-day follow-up period.
Invivyd’s monoclonal antibody candidate, VYD2311, met its co-primary endpoints in the Phase III LIBERTY study, demonstrating a superior safety and tolerability profile compared to the mRNA-based Comirnaty vaccine. Despite these clinical results, Invivyd shares declined following the company’s announcement that the topline readout for its separate Phase III DECLARATION trial has been delayed from the third quarter to October.
Phase III LIBERTY Study Results
In the LIBERTY trial (NCT07655180), researchers evaluated VYD2311 both as a standalone treatment and when co-administered with the Pfizer and BioNTech mRNA vaccine, Comirnaty. The study measured co-primary endpoints including the prevalence of treatment-emergent adverse events (TEAEs), injection site reactions (ISR), and hypersensitivity within a six-day window following dosing. According to the trial data, participants receiving VYD2311 experienced significantly fewer of these adverse events compared to those who received Comirnaty.
Beyond the initial six-day observation, VYD2311 maintained a favorable safety and tolerability profile over a 56-day follow-up period. The study investigators also found no clinical evidence to suggest that VYD2311 interferes with the immunological performance of the Comirnaty vaccine. These findings support Invivyd’s objective to pursue a Biologics License Application (BLA) for accelerated approval from the U.S. Food and Drug Administration (FDA).
Timeline Shift for DECLARATION Trial
While the LIBERTY study provided positive safety data, Invivyd’s financial outlook was affected by a shift in the reporting schedule for the Phase III DECLARATION trial (NCT07298434). The company confirmed that topline data regarding safety and immunogenicity from this second study will now be released in October, missing the previously anticipated third-quarter window.
Invivyd CEO Marc Elia stated, The observed profile of VYD2311 in LIBERTY and measured in vitro potency data of VYD2311 against circulating variants leave us confident and looking forward to the placebo-controlled safety and immunogenicity data we expect shortly in the DECLARATION study.
Elia added that the company aims to move toward regulatory filings as quickly as possible to provide a new option for Covid-19 protection.
Monoclonal Antibodies in the Current Market
The development of VYD2311 arrives during a period of shifting public and regulatory sentiment toward Covid-19 preventative measures in the United States. Previous monoclonal antibody treatments, such as Roche’s Ronapreve, saw their authorizations withdrawn after losing efficacy against emerging viral variants. Currently, Roche’s Actemra remains approved for a specific subgroup of patients diagnosed with Covid-19.
Vaccine distribution and uptake have faced additional pressure from declining public confidence and government policy changes. Analysis from GlobalData indicates that venture financing for vaccine innovation dropped by 82% following a 2025 move by U.S. Health Secretary Robert F. Kennedy Jr. to cancel 22 mRNA-linked research projects. This environment of heightened scrutiny follows executive orders from President Donald Trump that narrowed recommendations for childhood immunizations.