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Aprea Therapeutics Applies to FDA to Begin Clinical Studies of WEE1 Inhibitor

NEW YORK – Aprea Therapeutics has submitted an investigational new drug (IND) application to the US Food and Drug Administration seeking permission to begin clinical studies of its WEE1 inhibitor APR-1051, the company said Tuesday.

Once the agency clears the IND, Aprea will begin a Phase I/II trial to evaluate APR-1051 as a therapy for patients with tumors defined by certain genetic or molecular signatures. The firm has not disclosed the specific signatures it will explore in the trial but has indicated it will test APR-1051 in ovarian cancer and other tumors harboring CCNE amplification and other biomarkers. Aprea expects to begin the trial in the first half of 2024.

Aprea, based in Doylestown, Pennsylvania, noted that APR-1051 has demonstrated a differentiated profile from other WEE1 inhibitors in preclinical studies. The firm said that it showed selectivity for WEE1 versus off-target inhibition of the polo-like kinase (PLK) family of kinases and has a differentiated molecular structure and pharmacokinetic properties from other drugs in this class.

The firm is also studying an ATR inhibitor, ATRN-119, in a Phase I trial in advanced solid tumors harboring DNA damage response (DDR) mutations. The firm has another undisclosed DDR candidate in preclinical studies. Last year, Aprea received $2 million in funding from the National Cancer Institute to further develop its ATR and WEE1 inhibitors as treatments for ovarian cancer harboring homologous recombination mutations.

Aprea was developing the p53 reactivator APR-246, or eprenetapopt, for treating myelodysplastic syndromes, acute myeloid leukemia, and non-Hodgkin lymphoma. However, the firm has stopped studying eprenetapopt after it failed to improve outcomes as a frontline treatment for patients with TP53-mutant myelodysplastic syndromes in a Phase III trial.