secwatch.observer — SEC 8-K summary
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Issuer:     Genprex, Inc. (GNPX)
CIK:        0001595248
Form:       8-K
Filed at:   2025-11-19T23:59:59+00:00
Accession:  0001437749-25-035651
Event type: other_material
Sentiment:  positive
Materiality: 0.55
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Genprex adds Gabrail Cancer Center as new site for Acclaim-1 and Acclaim-3 Reqorsa trials
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- Gabrail Cancer Center (Canton, OH) is new clinical trial site for Acclaim-1 (NSCLC) and Acclaim-3 (ES-SCLC) studying Reqorsa gene therapy.
- Acclaim-1 Phase 2 expansion to enroll ~33 patients; interim analysis after 19 patients, enrollment of first 19 expected H1 2026.
- Acclaim-3 Phase 2 expansion to enroll ~50 patients; interim analysis after 25th patient, enrollment of first 25 expected H1 2026.
- Both trials have FDA Fast Track Designation; Acclaim-3 also has Orphan Drug Designation.
- Phase 1 showed no dose-limiting toxicities and early efficacy: some patients had prolonged progression-free survival, one partial response.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1595248/000143774925035651/0001437749-25-035651-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1595248/000143774925035651/gnpx20251116c_8k.htm
  HTML page:      https://secwatch.observer/filing/0001437749-25-035651

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