---
schema_version: "secwatch.filing_event.v1"
accession: "0001140361-25-008557"
form_type: "8-K"
ticker: "PDSB"
cik: "0001472091"
company_name: "PDS Biotechnology Corp"
filed_at: "2025-03-13T23:59:59+00:00"
generated_at: "2026-05-24T21:01:56.293079+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# PDS Biotech announces FDA clearance of IND for Versamune MUC1 + PDS01ADC to treat metastatic colorectal cancer

## Summary
- FDA cleared IND for Versamune MUC1 (formerly PDS0103) + PDS01ADC to treat MUC1-positive unresectable metastatic colorectal carcinoma in failed prior treatment.
- Phase 1/2 trial will be led by the National Cancer Institute under a CRADA with PDS Biotech.
- MUC1 is over-expressed in colon, pancreatic, ovarian, breast, and NSCLC; study targets MSS mCRC, which accounts for 95% of mCRC patients.
- U.S. Patent #12,201,685 covers methods of using Versamune platform and immunocytokines including PDS01ADC.
- Company's primary focus remains on VERSATILE-003 Phase 3 trial in HPV16-positive head and neck squamous cell carcinoma.

## SEC filing metadata
- accession: 0001140361-25-008557
- form_type: 8-K
- ticker: PDSB
- cik: 0001472091
- company_name: PDS Biotechnology Corp
- filed_at: 2025-03-13T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.7
- calibrated_materiality_score: 0.7
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1472091/000114036125008557/0001140361-25-008557-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1472091/000114036125008557/ef20045415_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001140361-25-008557
- JSON: https://secwatch.observer/filing/0001140361-25-008557.json
- Plain text: https://secwatch.observer/filing/0001140361-25-008557.txt

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