Aprea Therapeutics Announces that Safety Review Committee (SRC) Endorses Dosing of Patients with ATRN-119 at 800 mg Once Daily in Ongoing ABOYA-119 Clinical Trial

Core Insights - ATRN-119 is the first and only macrocyclic ATR inhibitor in clinical trials, showing best-in-class potential [1] - The ongoing ABOYA-119 clinical trial is on track to complete dose escalation and potentially generate initial human efficacy data in the second half of 2024 [1][4] - Safety Review Committee has approved the commencement of dosing at 800 mg once daily for Cohort 6, following positive safety and pharmacokinetic data from Cohort 5 [2][3] Clinical Trial Progress - A total of 17 patients have been enrolled across the first five cohorts with doses ranging from 50 mg to 550 mg once daily [3] - Preliminary signs of clinical benefit have been observed, with two patients achieving stable disease at different dose levels [3] - The Phase 1 dose escalation is expected to be completed by the fourth quarter of 2024, with the recommended Phase 2 dose anticipated in the first quarter of 2025 [4] Drug Characteristics - ATRN-119 is designed for patients with mutations in DNA damage response (DDR) pathways, addressing a high unmet medical need in oncology [4] - The drug has demonstrated a differentiated selectivity and toxicity profile compared to other ATR inhibitors [2][4] - Pharmacokinetic data indicate that systemic exposure increases with each dose level, with therapeutic plasma concentrations observed at doses of 550 mg and above [2][5]