Aprea Therapeutics, Inc. Announces Clinical Hold on Lymphoid Malignancy Program
August 12, 2021 at 06:00 am EDT
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Aprea Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has placed a clinical hold on its clinical trial evaluating eprenetapopt with acalabrutinib or with venetoclax and rituximab in lymphoid malignancies. No additional patients can be enrolled until the clinical hold is resolved, though patients on study deriving clinical benefit can continue to receive study treatment. Subsequent to receiving notification of a partial clinical hold on its myeloid malignancies program, Aprea was informed by FDA of a clinical hold on its lymphoid malignancy study. The FDA’s concerns referred to the safety and efficacy data from the Phase 3 MDS clinical trial. One CLL patient is currently on study treatment receiving eprenetapopt in combination with venetoclax and rituximab and has achieved complete remission (CR). Aprea intends to work closely with the FDA to address the specific questions raised, and seek to resolve the 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.