---
schema_version: "secwatch.filing_event.v1"
accession: "0001140361-25-025409"
form_type: "8-K"
ticker: "PDSB"
cik: "0001472091"
company_name: "PDS Biotechnology Corp"
filed_at: "2025-07-10T23:59:59+00:00"
generated_at: "2026-05-18T08:43:50.175875+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.55
calibrated_materiality_score: 0.55
confidence: "high"
source: SEC EDGAR
---

# PDS Biotech colorectal cancer cohort in NCI-led Phase 2 trial of PDS01ADC meets criteria for Stage 2 expansion

## Summary
- Stage 1 of NCI-led Phase 2 trial for PDS01ADC + FUDR/HAIP in metastatic colorectal cancer met RECIST v1.1 criteria for expansion.
- 6 of 9 patients achieved objective response in Stage 1, triggering Simon two-stage design expansion to up to 22 patients.
- Enrollment in Stage 2 for colorectal cancer cohort underway; completion targeted by Q4 2025.
- Two other cohorts (cholangiocarcinoma, adrenocortical cancer) continue enrolling in Stage 1.

## SEC filing metadata
- accession: 0001140361-25-025409
- form_type: 8-K
- ticker: PDSB
- cik: 0001472091
- company_name: PDS Biotechnology Corp
- filed_at: 2025-07-10T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.55
- calibrated_materiality_score: 0.55
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1472091/000114036125025409/0001140361-25-025409-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1472091/000114036125025409/ef20051830_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001140361-25-025409
- JSON: https://secwatch.observer/filing/0001140361-25-025409.json
- Plain text: https://secwatch.observer/filing/0001140361-25-025409.txt

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