Benzinga | Jul 16, 2020 07:15AM EDT

Aprea Therapeutics Reports Expansion Of Clinical Trial Evaluating Eprenetapopt For Front-Line Treatment Of TP53 Mutant Acute Myeloid Leukemia

Aprea Therapeutics, Inc.(NASDAQ:APRE), a biopharmaceutical company focused on developing and commercializing novel cancer therapeutics that reactivate mutant tumor suppressor protein, p53, today announced the expansion of patient enrollment in its Phase 1 clinical trial evaluating eprenetapopt in TP53 mutant AML. Following the completion of the safety lead-in portion of the clinical trial, the first expansion cohort will evaluate the combination of eprenetapopt with venetoclax and azacitidine in frontline TP53 mutant AML. The Company also plans to activate a cohort in the trial that will evaluate eprenetapopt with azacitidine in frontline TP53 mutant AML, expanding upon results for TP53 mutant AML patients recently presented from two independent Phase 1b/2 clinical trials.

The lead-in portion of the Phase 1 AML Trial evaluated the tolerability of eprenetapopt with venetoclax, with or without azacitidine, and no dose-limiting toxicities were observed in patients receiving either regimen. The expansion part of the clinical trial will treat approximately 30 front-line TP53 mutant AML patients with the triplet therapy of eprenetapopt with venetoclax and azacitidine. The Company will also evaluate front-line treatment with the doublet therapy of eprenetapopt and azacitidine in approximately 30 additional TP53 mutant AML patients. Safety and efficacy will be evaluated in both patient cohorts.

"We are encouraged by the tolerability of the eprenetapopt regimens observed to-date in the trial and look forward to continued evaluation of the potential efficacy of eprenetapopt with venetoclax and azacitidine for the frontline treatment of TP53 mutant AML," said Dr. Eyal Attar, Senior Vice President and Chief Medical Officer of Aprea. "In addition, we plan to also enroll a cohort of patients with TP53 mutant AML that will receive eprenetapopt with azacitidine to expand on the promising data generated in the two Phase 1b/2 MDS/AML trials, where the results in AML patients compare favorably to recently presented data for the venetoclax and azacitidine doublet regimen in TP53 mutant AML."