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Aprea Therapeutics files IND for new cancer drug APR-1051

Published 06/02/2024, 13:16
© Reuters.
APRE
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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.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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