Aprea Therapeutics' Safety Review Committee Approves 800 mg ATRN-119 Dosing in ABOYA-119 Trial

Aprea Therapeutics, Inc. has announced significant progress in its clinical study involving ATRN-119, a novel macrocyclic ATR inhibitor. The safety review committee has approved the commencement of patient dosing at 800 mg once daily, based on data from lower doses showing the drug’s safety and tolerability.

Dr. Nadeem Q. Mirza, Chief Medical Officer of Aprea, expressed satisfaction with the trial's progress and highlighted that pharmacokinetic data reveal increased systemic exposure with higher doses. Recent data presented at the AACR annual meeting indicate that plasma concentrations of ATRN-119 are reaching therapeutic levels at doses of 550 mg and higher. The company aims to provide further safety and efficacy data in the latter half of 2024 and complete dose escalation by the fourth quarter.

The ABOYA-119 trial is a Phase 1/2a multi-center study designed to evaluate ATRN-119 monotherapy in patients with advanced solid tumors and specific DDR pathway mutations. Phase 1 focuses on assessing tolerability, pharmacokinetics, and determining the recommended Phase 2 dose (RP2D). Following this, Phase 2a will test the drug's tolerability and efficacy.

So far, 17 patients have participated in the initial dose escalation phases, which ranged from 50 mg to 550 mg once daily. Encouragingly, two patients have shown stable disease, one at 50 mg and another at 200 mg. In March 2024, Aprea submitted an FDA amendment for additional cohorts at 1100 mg and 1300 mg doses, aiming for a total of eight cohorts.

Aprea anticipates announcing initial efficacy data for Phase 1 in the second half of 2024, with dose escalation completion expected by the fourth quarter of 2024. The recommended Phase 2 dose should be identified by the first quarter of 2025, with Phase 2a enrollment beginning soon after and additional data expected in the third quarter of 2025.

ATRN-119 is a highly selective, first-in-class macrocyclic inhibitor of ATR, targeting advanced tumors with DDR-related gene mutations. These cancers currently lack effective therapies and present a high unmet medical need.

Aprea Therapeutics, headquartered in Doylestown, Pennsylvania, is focused on precision oncology through synthetic lethality. Its lead program, ATRN-119, is in development for treating solid tumors, while another program, APR-1051, recently received FDA clearance for its IND application.

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