Ascentage announces FDA acceptance of IND application for Novel IAP Inhibitor APG-1387

Ascentage Pharma announced that the U.S. Food and Drug Administration (FDA) has accepted the Investigational New Drug (IND) application for APG-1387, a novel small molecule IAP inhibitor for the treatment of advanced solid tumors and hematologic malignancies.

Inhibitors of apoptosis (IAPs) are a group of proteins that act on the intrinsic pathway that blocks programmed cell death or apoptosis. High expression of IAP proteins has been linked to several cancers, including lung, head and neck, breast, gastrointestinal, and melanoma and multiple myeloma. APG-1387 is designed to bind to IAP protein monomers and dimers, unlike other IAP inhibitors in development which bind only to monomers. The Company believes that this dual inhibition may improve its effectiveness for more cancers. Ascentage has previously completed Phase 1 dose escalation studies with APG-1387 in China and Australia.

“The acceptance of a U.S. IND application represents another important milestone in the global clinical development of APG-1387,” said Dr. Yang Dajun, Chairman and CEO of Ascentage. “Based on preclinical and clinical results achieved to date, we believe APG-1387 could represent a first-in-class treatment option for patients with a wide range of refractory or resistant cancers.”