secwatch.observer — SEC 8-K summary
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Issuer:     PDS Biotechnology Corp (PDSB)
CIK:        0001472091
Form:       8-K
Filed at:   2025-05-22T23:59:59+00:00
Accession:  0001140361-25-020206
Event type: other_material
Sentiment:  positive
Materiality: 0.75
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

PDS Biotech reports positive extended follow-up data for Versamune HPV Phase 2 in head and neck cancer
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- VERSATILE-002: mOS of 39.3 months (CPS≥20) vs ~15 months for pembrolizumab; median follow-up 18.4 months.
- mOS of 30.0 months (CPS≥1) and 29.5 months (CPS 1-19), exceeding historical pembrolizumab results.
- Phase 3 VERSATILE-003 (n=351) enrolling; primary endpoint mOS with two interim analyses planned.
- Phase 2 window trial: 70% stable disease with Versamune HPV alone; 100% SD/PR with combo; met ctDNA endpoint.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1472091/000114036125020206/0001140361-25-020206-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1472091/000114036125020206/ef20049600_8k.htm
  HTML page:      https://secwatch.observer/filing/0001140361-25-020206

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