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Invivyd (Nasdaq: IVVD) announced positive topline results from its LIBERTY Phase 3 trial of VYD2311, an investigational monoclonal antibody for COVID-19 pre-exposure prophylaxis. In a head-to-head comparison against Pfizer’s COMIRNATY mRNA vaccine, VYD2311 showed clinically and statistically superior safety and tolerability.
What happened
The randomized, double-blind, active-controlled study in healthy adults tested VYD2311 alone, Pfizer’s COMIRNATY mRNA vaccine alone, and the two co-administered. LIBERTY met its co-primary endpoints (adverse events over the first 6 days) and its key secondary endpoint (events over the full 56 days), with VYD2311 showing superior safety and tolerability versus the mRNA vaccine over both short- and long-term follow-up. Key findings:
- Co-administration of VYD2311 with the mRNA vaccine boosted neutralizing antibody titers roughly 2.5x with no immunologic interference.
- No hypersensitivity or anaphylaxis occurred in the study.
- The data support a planned Biologics License Application to the FDA via the Accelerated Approval pathway, following a recent Type C meeting.
Why it matters
This is a head-to-head win against the current standard: an antibody candidate beating an approved mRNA vaccine on safety in a Phase 3 trial gives Invivyd real regulatory de-risking. It also targets the gap market — immunocompromised and other vulnerable patients who can’t rely on vaccines alone. TipRanks shows a Buy rating on IVVD with a $10 price target.
What to watch
The pivotal DECLARATION study’s topline safety and immunogenicity readout is expected in October; efficacy data would be unblinded after any accelerated approval is granted. Watch for the BLA submission timing and details from management’s investor call.
Related reading: Bristol Myers’ ZENBEXUS doubles deep responses in myeloma Phase 3
Could a safer antibody option win over vaccine-hesitant patients — or is the COVID market too crowded for another entrant?
Sources:
GlobeNewswire — Invivyd LIBERTY Phase 3 press release
TipRanks — Invivyd Phase 3 COVID antibody trial shows superior safetyAuto-posted by the Bull Lounge news desk.
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