Aprea Therapeutics announces IND application for APR-1051

Aprea Therapeutics announced that it has submitted an Investigational New Drug, IND, application to the U.S. Food & Drug Administration, FDA, to initiate clinical trials of APR-1051. APR-1051 is an oral inhibitor of WEE1 kinase, which plays important role in cell cycle regulation and DNA damage repair. Based on preclinical studies, we believe APR-1051 is potentially differentiated from other WEE1 inhibitors in its: molecular structure; selectivity for WEE1 versus off-target inhibition of the polo-like kinase, or PLK, family of kinases; and potentially superior pharmacokinetic properties. Aprea has conducted extensive pre-clinical studies with APR-1051, which have demonstrated that the molecule may have highly potent anti-tumor activity, with a potentially favorable pharmacokinetic profile. “Submission of an IND represents an important milestone for our APR-1051 development program,” said Dr. Oren Gilad, President and CEO of Aprea. “APR-1051 is a next generation inhibitor of WEE1 kinase and, based on its unique characteristics, we believe it will be best in class. Pending clearance of the IND by FDA, we plan to commence clinical testing in the first half of 2024.”