secwatch.observer — SEC 8-K summary
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Issuer:     Genprex, Inc. (GNPX)
CIK:        0001595248
Form:       8-K
Filed at:   2024-10-15T23:59:59+00:00
Accession:  0001437749-24-031202
Event type: other_material
Sentiment:  positive
Materiality: 0.65
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Genprex completes 0.09 mg/kg dose in Phase 1 Acclaim-3 trial; SRC approves escalation to highest dose
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- Completed 0.09 mg/kg dose group of Reqorsa + Tecentriq in ES-SCLC Phase 1; no dose-limiting toxicities reported.
- Safety Review Committee approved escalation to 0.12 mg/kg, the highest planned dose group.
- Phase 2 expansion will enroll 50 patients at 10-15 U.S. sites; primary endpoint is 18-week PFS rate.
- Acclaim-3 has FDA Fast Track and Orphan Drug Designations for this patient population.
- Company expects to start Phase 2 expansion in H2 2024, pending enrollment in the 0.12 mg/kg cohort.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1595248/000143774924031202/0001437749-24-031202-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1595248/000143774924031202/gnpx20241009_8k.htm
  HTML page:      https://secwatch.observer/filing/0001437749-24-031202

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