DOYLESTOWN - Aprea Therapeutics (NASDAQ:APRE), Inc., a biopharmaceutical company specializing in precision oncology, has submitted an Investigational New Drug (IND) application to the U.S. Food & Drug Administration (FDA) for its new cancer drug candidate, APR-1051. The submission, announced today, marks a significant step in the development of the drug, which is an oral inhibitor targeting WEE1 kinase, a key regulator in cell cycle and DNA damage repair.
APR-1051 has been distinguished from other WEE1 inhibitors based on its molecular structure, selectivity, and pharmacokinetic properties, according to preclinical studies. The studies suggest that APR-1051 may exhibit potent anti-tumor activity and a potentially favorable pharmacokinetic profile. Dr. Oren Gilad, President and CEO of Aprea, expressed confidence in the compound's unique characteristics and its potential to be a best-in-class therapy.
Pending FDA clearance, Aprea plans to initiate a Phase 1/2a dose escalation trial to assess the safety, tolerability, and preliminary efficacy of APR-1051 as a monotherapy in patients with specific genetic and/or molecular signatures. The company expects to commence clinical testing in the first half of 2024, with further details about the study design to be disclosed at a later date.
Aprea's lead program, ATRN-119, is also currently in development for solid tumor indications. The company's progress with APR-1051 represents an important milestone in its broader effort to advance precision oncology treatments.
The information in this article is based on a press release statement.
Investors and interested parties are advised to follow Aprea's updates, which may be disclosed through its investor relations website as part of its compliance with Regulation FD.
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