Clinical Trials Put Discovery Into Action

Every day, Aprea is one step closer to bringing breakthrough DDR-targeted therapies to market.

The goal of clinical trials is to advance our robust pipeline of novel, highly selective therapies and quickly bring them to market to benefit the greatest number of cancer patients possible.

Current Clinical Trials

Aprea’s leading candidates, ATRN-119 and APR-1051, are a significant opportunity to address the unmet medical needs of cancer patients.

Aprea is in the beginning stages of developing next-generation cancer therapies. Our lead candidate, ATRN-119, an ATR inhibitor, is currently in a Phase 1/2a trial, and our second candidate, APR-1051, a WEE1 inhibitor, will begin clinical studies in early 2024. Initial findings and data indicate a strong foundation for moving forward in both programs.

Lead Candidate, ATRN-119

Aprea’s macrocyclic ATR inhibitor, ATRN-119, is undergoing its first-in-human phase 1/2a trial in patients with advanced solid tumors.

Outcomes to date show:

Ongoing results from a pharmacokinetic data analysis will be presented in a future publication, and the dose expansion cohort in select cancers is on track to be initiated in 2Q 2024.

Preclinical Studies of APR-1051 Monotherapy

APR-1051 shows promise as a potent and highly selective WEE1 inhibitor that may offer new ways to treat CCNE1AMP cancers.

Preclinical Studies indicate:

These findings have justified IND-enabling studies for clinical development of APR-1051.

A Planned Phase I, Open-Label, Multicenter, First-In-Human Study of WEE1

Aprea will be investigating the safety, tolerability, pharmacokinetics and preliminary efficacy of APR-1051 in patients with advanced solid tumors.

We will be addressing unmet medical needs in potential specific target populations that may include:

Expanded Access / Compassionate Use Policy

Expanded access, also known as compassionate use, may be an option for some individuals with serious or life-threatening conditions, who have exhausted all available medical options and do not qualify for clinical trials. Given the stage of development for our investigational agents, Aprea is currently not offering expanded use programs.

Please continue to monitor clinicaltrials.gov for additional options and our website for changes to our Expanded Use programs.

Consistent with the 21st Century Cures Act, Aprea may revise this Expanded Access policy at any time. This policy applies to all of Aprea’s investigational products.