Invivyd’s Covid-directed monoclonal antibody (mAb) candidate, VYD2311, has demonstrated strong safety and tolerability in a Phase III study, but shares in the biotech slumped after delaying a topline readout for a separate study evaluating the drug.
In the Phase III LIBERTY study (NCT07655180), VYD2311 proved itself superior in safety and tolerability over BioNTech and Pfizer’s mRNA-based jab, Comirnaty. The vaccine won approval in the US in August 2021.
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In the trial, Invivyd evaluated the potential of VYD2311 against Comirnaty, while also looking into how the drug performed when co-administered alongside Comirnaty. The trial’s co-primary endpoints focused on the prevalence of treatment-emergent adverse events (TEAEs), injection site reactions (ISR) and hypersensitivity within the first six days post-dosing, as well as systemic AEs.
VYD2311 met both its co-primary endpoints, with far fewer patients experiencing any of the co-primary endpoint measures compared to Comirnaty after six days.
On top of its co-primary endpoint win, VYD2311 demonstrated its favourable long-term safety and tolerability profile, with stronger performance over a 56-day window.
Researchers also identified no signals to suggest that VYD2311 immunologically interferes with Comirnaty.
Following the positive outcome of this study, Invivyd is hoping to submit a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) vying for VYD2311’s accelerated approval in Covid-19, pending results of the Phase III DECLARATION trial (NCT07298434).
Shares in Invivyd slumped after the announcement, however, after the biotech said it now expects to reveal topline safety and immunogenicity data from DECLARATION in October. Originally, a readout in Q3 was expected.
Invivyd’s CEO, Marc Elia, said: “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.
“We want to move as quickly as possible to the regulatory filings required to bring Americans a new choice in protection from Covid.”
While mAbs have been approved for Covid before, several authorisations have been withdrawn, such as Roche’s Ronapreve (casirivimab and imdevimab), due to ineffectiveness against new variants. Roches’ Actemra (tocilizumab) remains approved in the US for a subgroup of Covid-19 patients.
A different option amid a troubled vaccine landscape
VYD2311 would represent a new option to Americans amid a troubled vaccine landscape in the country, as distrust in such preventative measures is on the rise within the key US market. Growing public scepticism is, in part, linked to the US Health Secretary Robert F Kennedy Jr’s (RFK) scientifically debunked claims that vaccines can cause autism, as well as President Donald Trump’s recent executive order (EO), which significantly narrowed the childhood immunisation recommendations.
While all vaccines have come under some scrutiny from the Trump administration, the mRNA-based vaccine approach has been in particularly sharp focus, as RFK Jr previously cut 22 projects linked to mRNA vaccines back in 2025. Following this, analysis from GlobalData, parent company of Clinical Trials Arena, revealed that venture financing for innovator vaccines dropped by 82%.
