secwatch.observer — SEC 8-K summary
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Issuer:     PDS Biotechnology Corp (PDSB)
CIK:        0001472091
Form:       8-K
Filed at:   2025-06-02T23:59:59+00:00
Accession:  0001140361-25-021032
Event type: other_material
Sentiment:  positive
Materiality: 0.70
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

PDS Biotech reports durable 30.0-month median OS from VERSATILE-002 in HPV16+ HNSCC
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- Median overall survival (mOS) steady at 30.0 months with ~4.5 months additional follow-up; lower 95% CI increased to 23.9 months.
- Median PFS: 6.3 months; ORR: 35.8%; disease control rate: 77.4%; median DoR: 21.8 months.
- VERSATILE-003 is the only ongoing Phase 3 trial specifically addressing 1L r/m HPV16-positive HNSCC.
- Data presented at ASCO 2025; no new safety signals; 22 of 53 patients still being followed.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1472091/000114036125021032/0001140361-25-021032-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1472091/000114036125021032/ef20050049_8k.htm
  HTML page:      https://secwatch.observer/filing/0001140361-25-021032

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