secwatch.observer — SEC 8-K summary
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Issuer:     Theriva Biologics, Inc. (TOVX)
CIK:        0000894158
Form:       8-K
Filed at:   2024-09-23T23:59:59+00:00
Accession:  0001104659-24-101892
Event type: regulatory
Sentiment:  positive
Materiality: 0.70
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Theriva Biologics achieves target enrollment of 92 patients in VIRAGE Phase 2b trial for VCN-01 in pancreatic cancer
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- Target enrollment of 92 evaluable patients (46 per arm) achieved across 15 sites in Spain and USA within 21 months.
- VCN-01 is a systemically-administered oncolytic adenovirus with FDA Orphan Drug and Fast Track Designations for metastatic PDAC.
- VCN-01 treatment arm: two IV doses (1x10^13 vp/patient) administered ~3 months apart, 7 days prior to gem/nab-paclitaxel cycles.
- Phase 1 data for single VCN-01 dose plus SoC (n=6): 83% overall response rate, median PFS 6.3 months, OS 20.8 months.
- Company plans regulatory engagements to discuss next steps, including potential interim data analysis.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/894158/000110465924101892/0001104659-24-101892-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/894158/000110465924101892/tm2424516d1_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-24-101892

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