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 - Aprea Therapeutics is advancing its clinical trial for ATRN-119, a macrocyclic ATR inhibitor, with the goal of generating initial human efficacy data in the second half of 2024 [1][2] - The Safety Review Committee has approved the commencement of dosing at 800 mg once daily, indicating positive progress in the trial [2][3] - Preliminary signs of clinical benefit have been observed in two patients, with stable disease reported [4] Clinical Trial Progress - The ABOYA-119 trial is a Phase 1/2a multi-center, open-label, dose-escalation study focusing on patients with advanced solid tumors and specific mutations in DDR pathways [2][6] - A total of 17 patients have been enrolled across five cohorts, with dosing levels ranging from 50 mg to 550 mg once daily [3] - An amendment for additional cohorts at 1100 mg and 1300 mg has been submitted to the FDA, aiming for a total of eight cohorts [3] Efficacy and Safety Data - Pharmacokinetic data indicate that systemic exposure increases with each dose level, with therapeutic plasma concentrations achieved at doses of 550 mg and above [2][7] - Initial efficacy data from Part 1 of the study is expected to be announced in the second half of 2024, with the completion of dose escalation anticipated by the fourth quarter of 2024 [5] - The recommended Phase 2 dose is expected to be determined in the first quarter of 2025, with enrollment for the Phase 2a cohort beginning shortly thereafter [5] Company Overview - Aprea Therapeutics is focused on precision oncology through synthetic lethality, with ATRN-119 being its lead program targeting solid tumors [8] - The company has completed all IND enabling studies for its oral WEE1 inhibitor, APR-1051, and has received FDA clearance for its IND [8]