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aprea therapeutics Aprea Therapeutics Reports Second Quarter 2021 Financial Results and Provides Update on Business Operations August 12 , 2021 BOSTON , Aug. 12 , 2021 ( 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 six months ended June 30 , 2021 and provided a business update . Business Operations Update : The Company is conducting , supporting , and planning multiple clinical trials of eprenetapopt ( APR - 246 ) and APR - 548 . On August 4 , 2021 , the U.S. Food and Drug Administration ( FDA ) placed a partial clinical hold on the clinical trials of eprenetapopt in combination with azacitidine in our myeloid malignancy programs . There are approximately 20 patients currently receiving eprenetapopt in combination with azacitidine in our myeloid malignancy programs , which includes the MDS , AML and post - transplant maintenance trials , all of which have completed enrollment . Patients who are benefiting from treatment can continue to receive study treatment . As part of the partial clinical hold , no additional patients should be enrolled to these clinical trials until the partial clinical hold is resolved , The Company intends to work closely with the FDA to analyze the data , address the specific questions raised , and seek to resolve the partial clinical hold as soon as possible . On August 11 , 2021 , the FDA placed a clinical hold on the Company's clinical trial evaluating eprenetapopt with acalabrutinib or with venetoclax and rituximab in lymphoid malignancies . There is one CLL patient currently on study treatment receiving eprenetapopt in combination with venetoclax and rituximab . This patient may continue to receive study treatment as long as the patient is deriving clinical benefit . No additional patients can be enrolled until the clinical hold is resolved . The Company intends to work closely with the FDA to address the specific questions raised , and seek to resolve the clinical hold as soon as possible . The Company's current clinical trials are as follows : -- • Phase 3 Frontline MDS Trial In June 2020 , the Company completed full enrollment of 154 patients in a pivotal Phase 3 trial of eprenetapopt with azacitidine for frontline treatment of patients with TP53 mutant MDS . The pivotal Phase 3 trial is supported by data from two Phase 1b / 2 investigator - initiated trials , one in the U.S. and one in France , testing eprenetapopt with azacitidine as frontline treatment in TP53 mutant MDS and AML patients . The data from the U.S. and French Phase 1b / 2 trials were published in The Journal of Clinical Oncology in January 2021 and February 2021 , respectively . In December 2020 , the Company announced that its pivotal Phase 3 trial failed to meet its predefined primary endpoint of complete remission ( CR ) rate . Analysis of the primary endpoint at this data cut demonstrated a higher CR rate ( 53 % more patients achieving a CR ) in the experimental arm receiving eprenetapopt with azacitidine versus the control arm receiving azacitidine alone but did not reach statistical significance . Based on a thorough analysis of the current Phase 3 trial data and comparisons to the U.S. and French Phase 1b / 2 trials the Company believes that despite similar types and frequency of adverse events observed in the Phase 3 experimental arm and the Phase 1b / 2 trials , patients in the Phase 3 experimental arm experienced substantially more study treatment dose modifications compared to the experience in the U.S. and French Phase 1b / 2 trials . The Company believes that dose modifications of eprenetapopt and azacitidine led to undertreatment in the Phase 3 experimental arm that negatively impacted efficacy , particularly the primary endpoint of CR rate . The Company continues to follow patients who remain on - study . Based on initial feedback from the FDA and the partial clinical hold on its myeloid malignancy programs , the Company believes that there is no registrational pathway for this Phase 3 trial . • Phase 2 MDS / AML Post - Transplant Trial – In July 2021 , the Company announced positive results from a single - arm , open - label Phase 2 clinical trial evaluating eprenetapopt with azacitidine as post - transplant maintenance therapy in TP53 mutant MDS and AML patients who have received an allogeneic stem cell transplant . The primary endpoint of the trial is the rate of relapse - free survival ( RFS ) at 12 months . In 33 patients enrolled in the trial , the RFS at one - year post - transplant