ATRN-119 is the first and only macrocyclic ATR inhibitor in the clinic, with best in class potential On track to complete dose escalation in ABOYA-119 clinical trial and potentially generate initial human efficacy data in 2H 2024 Through the first 5 cohorts, ATRN-119 has been found to be safe and well tolerated with no dose limiting toxicities (DLTs) observed DOYLESTOWN, Pa., May 28, 2024 (GLOBE NEWSWIRE) -- Aprea Therapeutics, Inc. (Nasdaq: APRE) (“Aprea”, or the “Company”), a clinical-stage biopharmaceutical company focused on precision oncology through synthetic lethality, today announced that the Safety Review Committee (SRC) overseeing the ongoing ABOYA-119 clinical trial has determined that dosing of patients with ATRN-119 at 800 mg once daily (Cohort 6) can commence and that Cohort 6 is open for enrollment.

ATRN-119是临床上第一个也是唯一一个大环ATR抑制剂，有望在ABOYA-119临床试验中完成剂量递增，并有可能在2024年下半年产生初步的人体疗效数据。通过前5个队列，ATRN-119被发现是安全且耐受性良好的，没有剂量限制性毒性（DLTs），观察到宾夕法尼亚州多伊尔斯敦，2024年5月28日（全球通讯社）——Aprea Therapeutics，Inc.（纳斯达克：APRE）（“Aprea”，或“公司”），一家临床阶段的生物制药公司，专注于通过合成致死性进行精确肿瘤学研究，今天宣布安全审查委员会（SRC）监督正在进行的ABOYA-119临床试验已经确定，每天一次服用800毫克ATRN-119的患者（队列6）可以开始服用，并且队列6可以登记。

This decision follows review of the safety and pharmacokinetic data from patients treated at 550 mg once daily (Cohort 5). “We are very pleased with the progress in the ABOYA-119 clinical trial and with the SRC’s recent endorsement to commence dosing of patients with ATRN-119 at 800 mg once daily representing progress in ATRN-119 development,” said Nadeem Q.

这一决定是在审查每天一次550毫克治疗的患者的安全性和药代动力学数据之后做出的（队列5）。Nadeem Q说：“我们对ABOYA-119临床试验的进展感到非常高兴，并且SRC最近批准开始每天一次服用800毫克ATRN-119的患者，这代表了ATRN-119开发的进展。”。

Mirza, M.D., M.P.H., Chief Medical Officer of Aprea. “Pharmacokinetic data show that the duration of systemic exposure substantially increases with each dose level of ATRN-119. New data reported at the recent AACR annual meeting show that plasma concentrations of the drug are entering the expected therapeutic range at dose levels of 550 mg and above1.

Mirza，M.D.，M.P.H.，Aprea首席医疗官。“药代动力学数据显示，全身暴露的持续时间随着ATRN-119的每个剂量水平而显着增加。在最近的AACR年会上报告的新数据显示，该药物的血浆浓度在550毫克及以上的剂量水平下进入预期的治疗范围1。

We anticipate to announce additional safety and initial efficacy data from this study in the second half of 2024 and to complete dose escalation by the fourth quarter. Overall, we are very excited by ATRN-119, which we believe is differentiated from other A.

我们预计将在2024年下半年公布这项研究的额外安全性和初始疗效数据，并在第四季度完成剂量递增。总的来说，我们对ATRN-119感到非常兴奋，我们认为它与其他A有所不同。