Aprea Therapeutics Announces a Partial Clinical Hold on Myeloid Malignancy Programs
August 06, 2021 at 06:16 am EDT
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On August 4, 2021, Aprea Therapeutics, Inc. (“Aprea”) was notified by the U.S. Food and Drug Administration (FDA) that it had placed a partial clinical hold on its clinical trials of eprenetapopt in combination with azacitidine in its myeloid malignancy programs. The partial clinical hold does not apply to Aprea’s ongoing clinical trials in lymphoid malignancies and solid tumors, or the APR-548 clinical trial. There are approximately 20 patients currently receiving eprenetapopt in combination with azacitidine in Aprea’s myeloid malignancy programs, which includes myelodysplastic syndromes (MDS), acute myeloid leukemia (AML), and post-transplant maintenance trials, all of which have completed enrollment. Patients who are benefiting from treatment can continue to receive study treatment. As part of the clinical hold, no additional patients can be enrolled to these trials until the partial clinical hold is resolved. Aprea intends to work closely with the FDA to analyze the data, address the specific questions raised, and seek to resolve the partial clinical hold as soon as possible.
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. 
