Invivyd's VYD2311 bests COMIRNATY on safety in LIBERTY Phase 3; BLA via Accelerated Approval planned

Invivyd, Inc.

LIBERTY randomized 210 healthy adults (18-49) 1:1:1 to 250mg VYD2311, COMIRNATY mRNA vaccine, or both; VYD2311 met all primary and secondary endpoints.
6-day TEAE/ISR/hypersensitivity: VYD2311 56.5% vs vaccine 91.4% (P<0.0001); 56-day rate 60.9% vs 91.4% (P<0.0001); combo arm 83.1% (P=0.21).
Systemic AEs at 6 days: 44.1% for VYD2311 vs 68.1% for mRNA vaccine (P=0.008); combination 50.0% vs 68.1% (P=0.023).
No VYD2311-related AE above Grade 2 and no hypersensitivity or anaphylaxis in any arm; co-administration raised vaccine neutralizing titers ~2.5x with no immunologic interference.
After a September Type C meeting, Invivyd plans a BLA under Accelerated Approval; DECLARATION safety/immunogenicity topline data expected in October, efficacy unblinded post-approval.

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