DOYLESTOWN, PA — Aprea Therapeutics, Inc. (Nasdaq: APRE), a clinical-stage biopharmaceutical company, has announced that its Investigational New Drug (IND) application for APR-1051 has been cleared by the U.S. Food and Drug Administration (FDA). This clearance marks a significant milestone in the development of the next-generation cancer treatment.
APR-1051 is a novel inhibitor of WEE1 kinase, a protein that plays a role in cell division and DNA repair. The drug is being developed to target cancers that overexpress Cyclin E, including ovarian and breast cancers. “The FDA’s clearance of our IND is a critical step in the APR-1051 development program,” said Dr. Oren Gilad, President and CEO of Aprea. “We believe it will be best in class, based on its unique characteristics.”
Preclinical studies suggest that APR-1051 is distinct from other WEE1 inhibitors in several ways. Its molecular structure and selectivity for WEE1, as opposed to off-target inhibition of the polo-like kinase, or PLK, family of kinases, set it apart. Additionally, the compound has potentially superior pharmacokinetic properties, which refer to how the body absorbs, distributes, metabolizes, and excretes the drug. Importantly, APR-1051 may not cause QT prolongation—a condition that can lead to irregular heart rhythms—at doses that significantly inhibit WEE1.
APR-1051 was discovered and preclinically evaluated by Aprea’s team of chemists and scientists. Extensive pre-clinical studies have shown that the molecule has potent anti-tumor activity and a favorable pharmacokinetic profile. Pre-clinical data also suggest that APR-1051 may demonstrate less toxicity than other WEE1 inhibitors.
With the IND application cleared, Aprea is set to initiate the Phase 1 ACESOT-1051 dose escalation trial. This study will assess the safety, tolerability, and preliminary efficacy of APR-1051. The company expects to enroll the first patient in this study in the first half of 2024 and provide an update by the end of the year.
While no head-to-head studies have been conducted with APR-1051, the clearance of the IND application signifies a significant step forward in the development of this potentially transformative cancer treatment.
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