secwatch.observer — SEC 8-K summary
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Issuer:     PDS Biotechnology Corp (PDSB)
CIK:        0001472091
Form:       8-K
Filed at:   2026-04-15T23:59:59+00:00
Accession:  0001140361-26-014693
Event type: other_material
Sentiment:  positive
Materiality: 0.75
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1472091/000114036126014693/0001140361-26-014693-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1472091/000114036126014693/ef20070560_8k.htm
  HTML page:      https://secwatch.observer/filing/0001140361-26-014693

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