Business
Aprea Therapeutics Reports Third Quarter 2020 Financial Results and Provides Update on Business Operations
BOSTON, Nov. 05, 2020 (GLOBE NEWSWIRE) -- Aprea Therapeutics, Inc. (Nasdaq: APRE), a biopharmaceutical company focused on developing and commercializing novel
About this update from Aprea Therapeutics, Inc.
[{"type":"text","content":"BOSTON, Nov. 05, 2020 (GLOBE NEWSWIRE) -- Aprea Therapeutics, Inc. (Nasdaq: APRE), a biopharmaceutical company focused on developing and commercializing novel cancer therapeutics that reactivate the mutant tumor suppressor protein, p53, today reported financial results for the three and nine months ended September 30, 2020 and provided a business update.\n “We made solid progress during the third quarter across our development pipeline as we approach top-line data from the Phase 3 clinical trial evaluating eprenetapopt with azacitidine for the treatment of front-line TP53 mutant myelodysplastic syndromes (MDS) patients by year-end 2020” said Christian S. Schade, Chairman and Chief Executive Officer of Aprea. “We continue to execute on our goal of expanding the clinical opportunities for our p53 reactivator programs, including expansion of our front-line AML clinical trials, enrollment of the first patients in our solid tumor trial, initiation of our lymphoma trial and clearance from FDA to proceed with the Phase 1 trial of our next-generation p53 reactivator, APR-548.” Business Operations Update: The Company is conducting, supporting, and planning multiple clinical trials of eprenetapopt (APR-246): Pivotal Phase 3 MDS Trial—The Company has completed the full enrollment of 154 patients in its pivotal Phase 3 randomized, controlled trial evaluating eprenetapopt with azacitidine as frontline therapy in HMA-naïve TP53 mutant myelodysplastic syndromes (MDS) patients with a primary endpoint of complete remission (CR) rate. The Company remains confident it will have top-line data available by year-end 2020.Phase 2 MDS/AML Post-Transplant Trial—The Company has completed the target enrollment of 31 patients in its single-arm, open-label Phase 2 trial evaluating eprenetapopt with azacitidine as post-transplant maintenance therapy in TP53 mutant MDS and acute myeloid leukemia (AML) patients who have received an allogeneic stem cell transplant.Phase 1/2 AML Trial—The Company is currently enrolling its Phase 1/2 trial evaluating the safety, tolerability, and preliminary efficacy of eprenetapopt therapy in TP53 mutant AML patients. The lead-in portion of the trial evaluated the tolerability of eprenetapopt with venetoclax, with or without azacitidine, and no dose-limiting toxicities were observed in 12 patients receiving either regimen. Based...