Aprea Therapeutics Inc. (NASDAQ: APRE) jumped 28.66% after the company announced that its Phase 1/2 study evaluating eprenetapopt treatment with azacitidine and venetoclax in patients with TP52 mutant AML had achieved the pre-specified complete remission efficacy endpoint.
Eprenetapopt achieved primary efficacy endpoint.
The complete remission (CR) rate was 37%. In contrast, the composite response rate of CR + CR with incomplete hematologic recovery (CRi), CR/CRi, was 53% in 30 evaluable patients for efficacy at the analysis date. Also, the study’s primary efficacy endpoint was met through the Simon 2-stage design. Notably, at the time of the data cut, 11 individuals were still receiving trial therapy and were being monitored for efficacy and safety. In the second half of 2021, Aprea hopes to meet with the US Food and Drug Administration (FDA) to review the dataset. The company will present the findings from the study at an upcoming scientific or medical conference.
Eprenetapopt (APR-246) is a tiny molecule that induces programmed cell death in human cancer cells by reactivating mutant and inactivated p53 protein. Eprenetapopt has shown preclinical anti-tumor potential in various solid and hematological malignancies.
Aprea to release results of eprenetapopt in July
Eyal Attar, Aprea Therapeutics Chief Medical Officer, said that the results of combining eprenetapopt with venetoclax and azacitidine in this difficult-to-treat TP53 mutant AML population were encouraging. He added Attar added that the findings coming after the FDA granted eprenetapopt Fast Track and Orphan Drug designations recently, show that the drug has potential in myeloid malignancies treatment. Most importantly, the company is making significant progress in its myeloid malignancies program and will give an update on the Phase 2 trial using eprenetapopt with azacitidine as a TP53 mutant MDS and AML maintenance therapy in patients who have received allogeneic stem cell transplant by July 2021.