{"schema_version":"secwatch.filing_event.v1","accession":"0001140361-25-005994","form_type":"8-K","ticker":"PDSB","cik":"0001472091","company_name":"PDS Biotechnology Corp","filed_at":"2025-02-26T23:59:59+00:00","discovered_at":"2026-05-14T18:03:03.720694+00:00","generated_at":"2026-05-26T03:29:38.394266+00:00","sec_items":["8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"PDS Biotech reports mOS of 42.4 months in ICI-naïve patients in JAMA Oncology","bullets":["Median overall survival 42.4 months in ICI-naïve patients vs. historical 7-12 months; for HPV16+ ICI-naïve, mOS not yet reached.","Confirmed ORR of 75% by irRECIST in HPV16+ ICI-naïve patients vs. historical 12-24%.","Median OS 17 months in ICI-resistant HPV16+ patients vs. historical 3-4 months; ORR 62.5% at high PDS01ADC dose.","Grade 3/4 treatment-related adverse events in 52% of patients; no treatment-related deaths.","Phase 3 VERSATILE-003 trial of Versamune HPV + pembrolizumab in head and neck cancer expected to start next month."],"urls":{"canonical":"https://secwatch.observer/filing/0001140361-25-005994","json":"https://secwatch.observer/filing/0001140361-25-005994.json","markdown":"https://secwatch.observer/filing/0001140361-25-005994.md","text":"https://secwatch.observer/filing/0001140361-25-005994.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1472091/000114036125005994/0001140361-25-005994-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1472091/000114036125005994/ef20044390_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-26T03:29:38.394266+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"}