secwatch.observer — SEC 8-K summary
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Issuer:     PDS Biotechnology Corp (PDSB)
CIK:        0001472091
Form:       8-K
Filed at:   2025-08-25T23:59:59+00:00
Accession:  0001140361-25-032433
Event type: other_material
Sentiment:  positive
Materiality: 0.85
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

PDS Biotech reports mOS 39.3 months in VERSATILE-002 Phase 2 vs 17.9 months standard of care
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- Median overall survival of 39.3 months (lower bound 23.9) in CPS≥1 patients with HPV16+ HNSCC; standard pembrolizumab ± chemo mOS is 17.9 months.
- 53 patients enrolled; no discontinuations due to treatment-related adverse events.
- Phase 3 VERSATILE-003 trial is underway based on these results.
- Durable multifunctional HPV16-specific CD8+ T cells induced by PDS0101 observed across demographics.
- Full data set to be published later this year.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1472091/000114036125032433/0001140361-25-032433-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1472091/000114036125032433/ef20054394_8k.htm
  HTML page:      https://secwatch.observer/filing/0001140361-25-032433

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