---
schema_version: "secwatch.filing_event.v1"
accession: "0001140361-25-005994"
form_type: "8-K"
ticker: "PDSB"
cik: "0001472091"
company_name: "PDS Biotechnology Corp"
filed_at: "2025-02-26T23:59:59+00:00"
generated_at: "2026-05-26T03:29:38.394266+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# PDS Biotech reports mOS of 42.4 months in ICI-naïve patients in JAMA Oncology

## Summary
- 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.

## SEC filing metadata
- accession: 0001140361-25-005994
- form_type: 8-K
- ticker: PDSB
- cik: 0001472091
- company_name: PDS Biotechnology Corp
- filed_at: 2025-02-26T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1472091/000114036125005994/0001140361-25-005994-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1472091/000114036125005994/ef20044390_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001140361-25-005994
- JSON: https://secwatch.observer/filing/0001140361-25-005994.json
- Plain text: https://secwatch.observer/filing/0001140361-25-005994.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.