{"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","discovered_at":"2026-05-14T18:02:44.056924+00:00","generated_at":"2026-05-18T08:43:50.175875+00:00","sec_items":["8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.55,"calibrated_materiality_score":0.55,"confidence":"high","headline":"PDS Biotech colorectal cancer cohort in NCI-led Phase 2 trial of PDS01ADC meets criteria for Stage 2 expansion","bullets":["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."],"urls":{"canonical":"https://secwatch.observer/filing/0001140361-25-025409","json":"https://secwatch.observer/filing/0001140361-25-025409.json","markdown":"https://secwatch.observer/filing/0001140361-25-025409.md","text":"https://secwatch.observer/filing/0001140361-25-025409.txt","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"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-18T08:43:50.175875+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"}