DOYLESTOWN, Pa. - Aprea Therapeutics, Inc. (NASDAQ: NASDAQ:APRE), a biopharmaceutical company specializing in precision oncology, announced today that the U.S. Food and Drug Administration (FDA) has approved its application to begin a Phase 1 clinical trial for APR-1051. The trial will assess the safety, tolerability, and preliminary efficacy of the oral WEE1 inhibitor in patients with advanced solid tumors, particularly those overexpressing Cyclin E, such as breast and ovarian cancers.
The investigational new drug (IND), APR-1051, is touted by Aprea's President and CEO, Dr. Oren Gilad, as a potential "best in class" therapy due to its unique molecular structure, selectivity, and pharmacokinetic properties. The company has conducted extensive pre-clinical studies demonstrating potent anti-tumor activity and a favorable pharmacokinetic profile for APR-1051. These studies also suggest that APR-1051 may exhibit less toxicity compared to other WEE1 inhibitors, although no direct comparative studies have been conducted.
The IND clearance allows Aprea to initiate the ACESOT-1051 dose escalation trial. Enrollment for the trial is expected to begin in the first half of this year, with an update on the trial's progress anticipated in Q4 2024.
Aprea's focus on synthetic lethality in oncology targets specific vulnerabilities in cancer cells. APR-1051's advancement into clinical trials represents a significant milestone for the company, which continues to develop its lead program, ATRN-119, another small molecule inhibitor designed for solid tumor indications.
This announcement is based on a press release statement.
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