Clinical-stage biopharma company Aprea Therapeutics, Inc. (APRE) Monday announced that the U.S. Food and Drug Administration has cleared its Investigational New Drug application for APR-1051.
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The company said further to the FDA clearance, it will evaluate the next-generation inhibitor of WEE1 kinase's therapeutic activity of APR-1051 in patients, focusing on Cyclin E overexpressing cancers, including ovarian and breast cancers.
Pre-clinical studies of APR-1051 have demonstrated that the molecule has potent anti-tumor activity, along with a favorable pharmacokinetic profile. Moreover, APR-1051 has the potential to demonstrate less toxicity than other WEE1 inhibitors, the company noted.
Aprea Therapeutics plans to initiate the Phase 1 ACESOT-1051 dose escalation trial to evaluate the safety, tolerability, and preliminary efficacy of APR-1051. Enrollment of the first patient in this study is expected in the first half of 2024.
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