DOYLESTOWN, PA — Aprea Therapeutics, Inc. (Nasdaq: APRE) recently showcased preliminary safety results for its WEE1 inhibitor, APR-1051, at the EORTC-NCI-AACR Symposium in Barcelona. This data comes from ACESOT-1051, a Phase 1 trial assessing the safety and early efficacy of APR-1051 in patients with advanced solid tumors that have specific genetic alterations.
The ongoing study’s first phase involves dose escalation, with up to 39 patients expected to participate. APR-1051 is administered orally in escalating doses ranging from 10 mg to 150 mg over 28-day cycles. Initial results from the first three cohorts, involving low doses, suggest that APR-1051 is well-tolerated, with no significant hematologic toxicity or QT prolongation observed. All recorded adverse effects were mild to moderate.
Dr. Philippe Pultar, Aprea’s Senior Medical Advisor, expressed optimism about the findings, stating, “These preliminary data from our ongoing Phase 1 study are encouraging, showing that APR-1051 is safe and well-tolerated.” He emphasized the drug’s design to selectively target WEE1, avoiding the off-target effects seen with other molecules in its class.
APR-1051 targets the WEE1 kinase, a critical enzyme in the DNA damage response pathway. Its unique structure and selectivity may address limitations associated with other WEE1 inhibitors. The trial aims to explore the full therapeutic potential of APR-1051, with further efficacy data expected in 2025.
Anthony Tolcher, M.D., from NEXT Oncology, highlighted the trial’s significance, noting the minimal toxicity observed so far. “The preliminary findings from ACESOT-1051 are promising and we are encouraged by the minimal toxicity in the patients treated so far,” Tolcher commented, underscoring the potential of WEE1 as a therapeutic target.
Enrollment for the study continues across multiple U.S. sites, with additional locations planned. As Aprea Therapeutics advances this promising WEE1 inhibitor, the oncology community remains hopeful for new treatments that could improve outcomes for patients with challenging cancer profiles.
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