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Invivyd reports REVOLUTION program updates and advancement of measles antibody candidate VMS063
Summary
Invivyd said its Phase 3 DECLARATION trial was upsized by about 500 subjects after a pre-specified sample size re-estimation, which is expected to move top-line timing to the third quarter of 2026, and the company announced discovery and IND-enabling steps for a half-life–extended measles monoclonal antibody candidate, VMS063.
Content
Invivyd announced updates to its REVOLUTION clinical program alongside news of a new measles antibody candidate. The company reported that a pre-specified sample size re-estimation in the Phase 3 DECLARATION trial was triggered when 1,500 of 1,818 enrolled participants reached Day 45. Invivyd said the trial will be upsized and that timing for top-line results is expected to shift modestly. The company also described the discovery and IND-enabling progression of VMS063, a half-life–extended measles monoclonal antibody candidate.
Key facts:
- The pre-specified sample size re-estimation was conducted when 1,500 of 1,818 randomized subjects reached Day 45 (April 6, 2026).
- The DECLARATION upsizing adds approximately 500 additional subjects and the company expects top-line results to move from mid-year guidance into the third quarter of 2026.
- Invivyd reported that pooled, blinded COVID-19 event accumulation to date (about 50% of study progress) can already support the high end of anticipated VYD2311 efficacy according to the company.
- Invivyd and the U.S. FDA have aligned on an initial Pediatric Study Plan for a BLA-directed pediatric immunobridging and safety study called DRUMMER; that study would be actioned only if DECLARATION is successful.
- VMS063 is described as a novel, half-life–extended monoclonal antibody that targets the measles Fusion (F) protein and showed potent in vitro neutralization across lineages such as B3, D8, and Edmonston in company assays.
- Invivyd has begun IND-enabling studies and regulatory outreach for VMS063 and stated a target of IND readiness in late 2026.
Summary:
The trial upsizing is presented as a measure to increase statistical robustness and is expected to push top-line timing to Q3 2026 while the company continues recruitment and event accumulation. The aligned pediatric plan for DRUMMER would follow only if the DECLARATION pivotal study is successful. For measles, Invivyd has advanced VMS063 toward IND-enabling work and regulatory engagement with an internal target of late 2026 for IND readiness. More detailed timing and outcomes were not provided.
