Aprea Therapeutics, Inc. Announces Updated Results from Its Phase 2 Trial Evaluating Eprenetapopt with Azacitidine for Post-Transplant Maintenance Therapy in Patients with TP53 mutant MDS and AML
December 13, 2021 at 08:00 am EST
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Aprea Therapeutics, Inc. announced updated results from its Phase 2 trial evaluating eprenetapopt with azacitidine for post-transplant maintenance therapy in patients with TP53 mutant MDS and AML at the 2021 ASH Annual Meeting. In 33 patients enrolled in the trial, the relapse free survival (RFS) at 1 year post-transplant was 60% and the median RFS was 12.5 months. The overall survival (OS) at 1 year post-transplant was 79%, with a median OS of 20.6 months. Published studies evaluating post-transplant outcomes in TP53 mutant MDS and AML patients have reported a 1-year post-transplant RFS of ~30% and a median OS of ~5-8 months. In addition, the post- transplant regimen of eprenetapopt and azacitidine was well tolerated among patients in the clinical trial. Given the encouraging data, the Company intends to explore opportunities to conduct future randomized clinical trials to further assess safety and efficacy of this combination in the post-transplant maintenance setting.
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. Announces Updated Results from Its Phase 2 Trial Evaluating Eprenetapopt with Azacitidine for Post-Transplant Maintenance Therapy in Patients with TP53 mutant MDS and AML