Our lead molecule, APR-246, has been shown to reactivate mutant p53 and thereby induce programmed cell death in human cancer cells. APR-246 has demonstrated compelling pre-clinical anti-tumor activity in a wide variety of solid and hematological (blood) tumors, including MDS, AML and ovarian cancer, among others. Additionally, strong synergy has been seen with both traditional anti-cancer agents, such as chemotherapy, as well as newer mechanism-based anti-cancer drugs and immuno-oncology checkpoint inhibitors.

A Phase I clinical study has been completed, demonstrating a favorable safety profile and both biological and clinical responses in hematological tumors with mutations in the p53 gene. Phase Ib/II clinical studies in MDS / AML and a Phase III clinical study in MDS are ongoing. Additional hematologic malignancy indications are planned.

Expanded Access Policy

At Aprea Therapeutics, our focus is on the discovery and development of novel anti-cancer compounds that reactivate the tumor protein p53.  The goal of our current clinical studies is to enroll patients and obtain clinical data required for submission, review and approval by regulatory authorities of marketing applications for our investigational therapies.  We believe that focusing on our clinical studies is the most appropriate way to achieve this goal; therefore, we do not currently offer access to APR-246 outside of our clinical studies and, at this time, we have no Expanded Access (EA) or Compassionate Use (CU) programs.

Further details of all APR-246 clinical trials are posted on the US NIH website ClinicalTrials.gov. A link to APR-246 clinical trials is below:

https://clinicaltrials.gov/ct2/results?cond=&term=APR-246&cntry=&state=&city=&dist=

For all inquiries relating to APR-246, please contact: info@aprea.com

Aprea Therapeutics may revise this Expanded Access policy at any time.