Aprea Therapeutics, Inc. today 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.
DOYLESTOWN, Pa., Feb. 06, 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 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: 1) molecular structure; 2) selectivity for WEE1 versus off-target inhibition of the polo-like kinase, or PLK, family of kinases; and 3) 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 (PK) 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.”
Clearance of the IND application will allow Aprea to initiate a Phase 1/2a dose escalation trial to evaluate the safety, tolerability, and preliminary efficacy of APR-1051 as a monotherapy in patients with a defined genetic and/or molecular signatures. Further details on the design of this study will be provided at a later date.
* No head-to-head studies have been conducted with APR-1051
About Aprea
Aprea Therapeutics, Inc. is a clinical-stage biopharmaceutical company headquartered in Doylestown, Pennsylvania, focused on precision oncology through synthetic lethality. The Company’s lead program is ATRN-119, a clinical-stage small molecule ATR inhibitor in development for solid tumor indications. Aprea has completed all IND enabling studies for its oral, small molecule WEE1 inhibitor, APR-1051, and is guiding towards FDA clearance of its IND during Q1 2024. For more information, please visit the company website at www.aprea.com.
The Company may use, and intends to use, its investor relations website at https://ir.aprea.com/ as a means of disclosing material nonpublic information and for complying with its disclosure obligations under Regulation FD.
Forward-Looking Statement
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Investor Contact:
Mike Moyer
LifeSci Advisors
mmoyer@lifesciadvisors.com
