Aprea Therapeutics Announces Phase 1/2 Trial of Eprenetapopt + Venetoclax + Azacitidine in TP53 Mutant AML Meets Complete Remission Primary Efficacy Endpoint
June 16, 2021 at 08:00 am EDT
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Aprea Therapeutics, Inc. announced that the Phase 1/2 trial evaluating the frontline treatment of eprenetapopt with venetoclax and azacitidine in patients with TP53 mutant AML has met the pre-specified primary efficacy endpoint of complete remission (CR) rate. In 30 patients who were evaluable for efficacy at the time of the analysis, the CR rate was 37% and the composite response rate of CR plus CR with incomplete hematologic recovery (CRi), CR/CRi, was 53%. The trial met the primary efficacy endpoint of CR, which is based on a Simon 2-stage design. As of the data cut, 11 patients remain on study treatment and continue to be followed for safety and efficacy. The Company plans to discuss the dataset with the U.S. Food and Drug Agency (FDA) in the second half of 2021 and expects to present data from the trial at a future scientific or medical conference.
Aprea Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on precision oncology through synthetic lethality. The Company's advanced synthetic lethality product candidate is ATRN-119, a clinical-stage small molecule inhibitor of ataxia telangiectasia and Rad3-related (ATR) a kinase that plays a critical role in DNA damage response (DDR). ATR and Checkpoint Kinase 1 are critical DDR kinases that prevent the collapse of replication forks into DNA double-strand breaks. It has completed all IND enabling studies for its oral, small molecule WEE1 inhibitor, APR-1051, and received United States Food and Drug Administration (FDA) clearance of its IND. It has an early-stage program that is in the lead optimization stage, for an undisclosed DDR target. The Company is evaluating potential combination opportunities within its pipeline, including research on the combination of ATRN-119 and APR-1051 that is supported by a Phase II SBIR grant from the National Cancer Institute.
APREA THERAPEUTICS, INC. 
