FDA Orders Clinical Hold on Aprea’s P53 Reactivator in Myeloid Malignancies Trial

The FDA has ordered a clinical hold on Aprea's novel cancer therapeutic eprenetapopt.

The Boston-based biotech announced that the FDA has placed a partial hold on its clinical trials of eprenetapopt, a p53 gene reactivator, in combination with the chemotherapy drug azacitidine in the company’s myeloid malignancy programs.

Eprenetapopt, the company’s lead candidate, aims to reactivate the body’s natural tumor suppressor protein on gene p53. Tumor protein gene p53 (TP53) plays a crucial role in the suppression of cancer growth. The gene also can determine the type of myeloid malignancy a person has, their treatment response and risk of the cancer transforming to acute myeloid leukemia (AML).

Eprenetapopt is in clinical development for hematologic malignancies and solid tumors.

No details were forthcoming about why the FDA ordered the hold.

“Based on the totality of the data we have for eprenetapopt, we believe that it continues to be a promising therapeutic option for cancer patients,” said Christian S. Schade, chairman and CEO of Aprea.