Aprea: FDA Puts Clinical Hold on Lymphoid Malignancy Program

 Aprea Therapeutics Inc. on Thursday said the U.S. Food and Drug Administration has placed a clinical hold on its clinical trial evaluating eprenetapopt with acalabrutinib or with venetoclax and rituximab in lymphoid malignancies.

The Boston biopharmaceutical company said the agency's concerns relate to the safety and efficacy data from a Phase 3 study in myelodysplastic syndromes.

Aprea said it can't enroll any additional patients in the study until the hold is resolved, though current patients who are deriving clinical benefit can continue to receive study treatment.

The news comes a week after Aprea said the FDA had placed a partial clinical hold on its studies of eprenetapopt in combination with azacitidine in its myeloid malignancy programs.

Aprea said it plans to work closely with the FDA to address the agency's questions, adding that it aims to resolve the clinical hold as soon as possible.

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