DOYLESTOWN, PA — Aprea Therapeutics, Inc. (Nasdaq: APRE) announced a significant development in its ongoing ABOYA-119 clinical trial. The Safety Review Committee (SRC) has approved the commencement of dosing patients with ATRN-119 at 800 mg once daily. This marks the opening of Cohort 6 for enrollment following a review of safety and pharmacokinetic data from patients treated at the previous dose level of 550 mg.
Chief Medical Officer Nadeem Q. Mirza, M.D., M.P.H., expressed optimism about the progress. “We are very pleased with the SRC’s endorsement to commence dosing of patients with ATRN-119 at 800 mg once daily. Pharmacokinetic data shows that systemic exposure increases substantially with each dose level of ATRN-119,” he said. Recent data presented at the American Association for Cancer Research (AACR) meeting indicated that plasma concentrations of the drug reached the expected therapeutic range at dose levels of 550 mg and higher.
ABOYA-119 is a Phase 1/2a multi-center, open-label trial focusing on ATRN-119 monotherapy for patients with advanced solid tumors possessing specific mutations in DNA damage response (DDR) pathways. In Phase 1, the study aims to assess the drug’s tolerability, pharmacokinetics, and recommended dose for Phase 2. Upon completing Phase 1, the company expects to pinpoint the appropriate Phase 2 dose, which will then be used in the cohort expansion phase to evaluate the drug’s tolerability and potential efficacy further. Refer to clinicaltrials.gov NCT04905914.
Seventeen patients have participated in the first five cohorts, receiving doses ranging from 50 mg to 550 mg once daily. Based on promising safety profiles observed, Aprea submitted an amendment to the FDA to include additional cohorts with doses of 1100 mg and 1300 mg. The goal is to expand the study to eight cohorts in total.
Preliminary results have shown clinical benefits. Two patients achieved stable disease, one in the 50 mg cohort and another in the 200 mg cohort. The latter patient showed prolonged stability on days 55, 112, and 168. These findings were highlighted in a poster presentation at the AACR Annual Meeting in April.
Looking ahead, Aprea plans to announce initial efficacy data from Part 1 of the study in the second half of 2024. The completion of the Phase 1 dose escalation is expected by the fourth quarter of 2024, with the recommended Phase 2 dose identified by the first quarter of 2025. Enrollment for the Phase 2a cohort is slated to begin in early 2025, with additional safety and efficacy data anticipated by the third quarter of that year.
ATRN-119 is a first-in-class macrocyclic inhibitor targeting ATR, a key player in the DNA damage response mechanism. This drug is designed for patients with mutations in DDR-related genes, who currently face poor prognoses and lack effective therapies. The development of ATRN-119 aims to address this high unmet medical need, offering new hope for patients battling these challenging cancers.
The progress in the ABOYA-119 trial represents a significant step forward in cancer treatment, potentially paving the way for more effective therapies for patients with limited options. As the trial advances, the medical community and patients alike will be watching closely for further developments and data.
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