secwatch.observer — SEC 8-K summary
======================================

Issuer:     PDS Biotechnology Corp (PDSB)
CIK:        0001472091
Form:       8-K
Filed at:   2025-02-26T23:59:59+00:00
Accession:  0001140361-25-005994
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 of 42.4 months in ICI-naïve patients in JAMA Oncology
-----------------------------------------------------------------------------

- Median overall survival 42.4 months in ICI-naïve patients vs. historical 7-12 months; for HPV16+ ICI-naïve, mOS not yet reached.
- Confirmed ORR of 75% by irRECIST in HPV16+ ICI-naïve patients vs. historical 12-24%.
- Median OS 17 months in ICI-resistant HPV16+ patients vs. historical 3-4 months; ORR 62.5% at high PDS01ADC dose.
- Grade 3/4 treatment-related adverse events in 52% of patients; no treatment-related deaths.
- Phase 3 VERSATILE-003 trial of Versamune HPV + pembrolizumab in head and neck cancer expected to start next month.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1472091/000114036125005994/0001140361-25-005994-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1472091/000114036125005994/ef20044390_8k.htm
  HTML page:      https://secwatch.observer/filing/0001140361-25-005994

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