Aprea hit with second clinical hold on lead candidate

Aug. 12, 2021

After instituting a partial clinical hold on Aprea Therapeutics myeloid malignancies program, the FDA has now placed a clinical hold on the drugmaker's lymphoid malignancy study.

The Boston-based biotech announced that the FDA placed a hold on its clinical trial evaluating eprenetapopt (APR-246) — Apea's lead drug candidate — with AstraZeneca’s Calquence or with AbbVie/Genetech's Venclexta and Roche/Biogen’s Rituxan in lymphoid malignancies.

Last week, the regulator instituted a partial clinical hold on Aprea's clinical trials of the same drug, combined with Bristol Myers Squibb’s Vidaza, in its myeloid malignancy programs.

According to the drugmaker, the agency's concerns referred to the safety and efficacy data from the phase 3 myelodysplastic syndromes (MDS) — a group of bone marrow disorders — clinical trial.

Eprenetapopt, a small molecule designed to reactivate mutant and inactivated p53 tumor suppressor protein, has received Breakthrough Therapy, Orphan Drug and Fast Track designations from the FDA for MDS, and Orphan Drug designation from the European Commission for MDS, AML and ovarian cancer.

Aprea said it intends to work closely with the FDA to address the specific questions raised and resolve the clinical holds as soon as possible.

Read the press release