other material
confidence high
sentiment positive
materiality 0.80
OKI-219 well-tolerated in first human trial; no hyperglycemia, Part 1b combo initiated
OnKure Therapeutics, Inc.
- 17 patients dosed across 300–900 mg BID; no dose interruptions, reductions, or discontinuations.
- Only Grade 1 TRAEs reported (diarrhea, nausea, pruritus); no hyperglycemia observed.
- 900 mg BID achieved steady-state PK with near-continuous EC80 coverage for pAKT inhibition.
- Two HR+/HER2- breast cancer patients on 300 mg showed >7 months stable disease; one had >95% ctDNA reduction.
- Part 1b evaluating OKI-219 + fulvestrant initiated; single-agent/combination data expected 2H 2025.