---
schema_version: "secwatch.filing_event.v1"
accession: "0001140361-26-014693"
form_type: "8-K"
ticker: "PDSB"
cik: "0001472091"
company_name: "PDS Biotechnology Corp"
filed_at: "2026-04-15T23:59:59+00:00"
generated_at: "2026-05-15T06:04:59.488649+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# PDS Biotech reports 78% ORR for PDS01ADC in MSS mCRC liver metastases trial

## Summary
- Stage 1 of Phase 2 NCI-led trial: 77.8% ORR (7/9) with PDS01ADC plus HAIP vs 35% in parallel study without PDS01ADC.
- PDS01ADC plus HAIP showed ~85% 2-year survival rate; comparator arm had ~40% for MSS/pMMR metastatic colorectal cancer.
- Extrahepatic progression-free survival median not reached at 13.1 months minimum follow-up; comparator median 8.1 months.
- Data published in JCO Oncology Advances March 10, 2026; trial enrolls patients who failed at least one prior treatment.
- MSS/pMMR colorectal liver metastases represent ~95% of mCRC where checkpoint inhibitors have failed.

## SEC filing metadata
- accession: 0001140361-26-014693
- form_type: 8-K
- ticker: PDSB
- cik: 0001472091
- company_name: PDS Biotechnology Corp
- filed_at: 2026-04-15T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1472091/000114036126014693/0001140361-26-014693-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1472091/000114036126014693/ef20070560_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001140361-26-014693
- JSON: https://secwatch.observer/filing/0001140361-26-014693.json
- Plain text: https://secwatch.observer/filing/0001140361-26-014693.txt

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