secwatch.observer — SEC 8-K summary
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Issuer:     Invivyd, Inc. (IVVD)
CIK:        0001832038
Form:       8-K
Filed at:   2024-09-04T23:59:59+00:00
Accession:  0000950170-24-103100
Event type: other_material
Sentiment:  neutral
Materiality: 0.50
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Invivyd doses first participants in Phase 1 trial of COVID-19 mAb candidate VYD2311
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- Phase 1 trial (NCT06523153) of VYD2311 dosed first healthy volunteers; placebo-controlled, randomized.
- Trial in Australia evaluating multiple dose levels, including intramuscular administration.
- Preliminary data readouts expected Q4 2024; additional clinical readouts anticipated in 2025.
- VYD2311 discovered via affinity maturation against recent SARS-CoV-2 variants; high in vitro potency.
- Program builds on PEMGARDA (pemivibart), which received FDA EUA for COVID-19 PrEP in immunocompromised.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1832038/000095017024103100/0000950170-24-103100-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1832038/000095017024103100/ivvd-20240904.htm
  HTML page:      https://secwatch.observer/filing/0000950170-24-103100

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer