Aprea Announces First Patient Enrolled in Phase Ib/II Clinical Study of APR-246

Aprea Therapeutics announced the first patient was enrolled in a Phase Ib/II clinical study of APR-246 in platinum-resistant high-grade serous ovarian cancer (HGSOC).

"We are excited to begin this important clinical study in a subset of high-grade serous ovarian cancer patients with few treatments options," said Christian S. Schade, President and Chief Executive Officer of Aprea Therapeutics. "This study complements our ongoing randomized Phase II study in platinum sensitive HGSOC patients and further enhances our growing clinical strategy of testing APR-246 with various combinations and in multiple tumor types, all with a high prevalence of mutated p53 protein.  We look forward to seeing the results of this study in first half of 2018."

The p53 tumor suppressor gene is the most frequently mutated gene in human cancer, occurring in approximately 50% of all human tumors.  These mutations are often associated with resistance to anticancer drugs and poor overall survival, representing a major unmet medical need in the treatment of cancer.

APR-246 has been shown to reactivate mutant p53 protein, by reconverting mutant p53 into wild-type p53 conformation and function, and thereby induce programmed cell death in human cancer cells.  APR-246 has demonstrated compelling pre-clinical antitumor activity in a wide variety of solid and hematological (blood) tumors, including ovarian cancer, small cell lung cancer, oesophageal cancer and acute myeloid leukemia (AML), among others.  Additionally, strong synergy has been seen with both traditional anticancer agents, such as chemotherapy, as well as newer mechanism-based anticancer drugs and immuno-oncology checkpoint inhibitors. In addition to pre-clinical testing, a Phase I/Ib clinical program with APR-246 has been completed, demonstrating a favorable safety profile and both biological and confirmed clinical responses in hematological malignancies and solid tumors with mutations in the p53 gene. The Company is enrolling a randomized Phase II study in platinum-sensitive ovarian cancer, a Phase Ib/II study in myelodysplastic syndrome and is expecting to initiate additional clinical studies of APR-246 in 2017.