secwatch.observer — SEC 8-K summary
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Issuer:     Genprex, Inc. (GNPX)
CIK:        0001595248
Form:       8-K
Filed at:   2024-12-16T23:59:59+00:00
Accession:  0001437749-24-037525
Event type: other_material
Sentiment:  positive
Materiality: 0.70
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Genprex completes Phase 1 dose escalation of Reqorsa + Tecentriq in ES-SCLC; Phase 2 opens
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- No dose-limiting toxicities observed; RP2D set at 0.12 mg/kg (highest dose tested).
- Safety Review Committee approved opening Phase 2 expansion; enrollment has started.
- Phase 2 will enroll ~50 patients at 10-15 U.S. sites; primary endpoint is 18-week PFS rate.
- Futility analysis after 25th patient reaches 18 weeks of follow-up.
- Acclaim-3 has FDA Fast Track and Orphan Drug designations for ES-SCLC.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1595248/000143774924037525/0001437749-24-037525-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1595248/000143774924037525/gnpx20241205_8k.htm
  HTML page:      https://secwatch.observer/filing/0001437749-24-037525

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