secwatch.observer — SEC 8-K summary
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Issuer:     PDS Biotechnology Corp (PDSB)
CIK:        0001472091
Form:       8-K
Filed at:   2025-07-10T23:59:59+00:00
Accession:  0001140361-25-025409
Event type: other_material
Sentiment:  positive
Materiality: 0.55
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1472091/000114036125025409/0001140361-25-025409-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1472091/000114036125025409/ef20051830_8k.htm
  HTML page:      https://secwatch.observer/filing/0001140361-25-025409

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