Ascentage Pharma Doses First Patient With APG-115
Ascentage Pharma, a globally focused biotechnology company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and age-related diseases, has announced that the Phase Ib study of the company's novel MDM2-p53 inhibitor candidate APG-115 as a single agent or in combinations for the treatment of Chinese patients with relapsed/refractory acute myeloid leukemia (r/r AML), or relapsed/progressed high/very high-risk myelodysplastic syndrome (MDS) has dosed its first patient in China. As the first MDM2-p53 inhibitor entering clinical studies for the treatment of solid tumors in China, this is the first study of APG-115 in patients with hematologic malignancies.
AML is a clonal proliferative disease of the bone marrow, of which the incidence rate increases with age. AML is the most common type of leukemia in China, with an incidence rate of 1.62-2.32 cases per 100,000. MDS is a heterogeneous hematopoietic disease caused by abnormal pluripotent stem cells. The incidence rate of MDS in China is approximately 5 cases per 100,000. As a result, both refractory/progressed AML and MDS represent an urgent medical need for more effective therapies.
APG-115 is the first MDM2-p53 inhibitor entering clinical development in China, with multiple ongoing clinical studies in solid tumors in China and the US. At present, APG-115 is being investigated in a range of hematologic malignancies globally.