{"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","discovered_at":"2026-05-14T18:02:32.327828+00:00","generated_at":"2026-05-15T06:04:59.488649+00:00","sec_items":["8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"PDS Biotech reports 78% ORR for PDS01ADC in MSS mCRC liver metastases trial","bullets":["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."],"urls":{"canonical":"https://secwatch.observer/filing/0001140361-26-014693","json":"https://secwatch.observer/filing/0001140361-26-014693.json","markdown":"https://secwatch.observer/filing/0001140361-26-014693.md","text":"https://secwatch.observer/filing/0001140361-26-014693.txt","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"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-15T06:04:59.488649+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}