other material
confidence high
sentiment positive
materiality 0.65
Genprex completes 0.09 mg/kg dose in Phase 1 Acclaim-3 trial; SRC approves escalation to highest dose
Genprex, Inc.
- 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.