Ascentage Pharma Announces U.S. FDA Acceptance of IND Application for Clinical Study of Novel IAP Inhibitor APG-1387 to Treat Advanced Solid Tumors and Blood Cancers

ROCKVILLE, MARYLAND | Ascentage Pharma, a global clinical-stage biopharmaceutical company dedicated to developing apoptosis-targeted therapies, today 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.”

About APG-1387

APG-1387 is a novel small molecule inhibitor of apoptosis (IAP), which was discovered and is being developed by Ascentage Pharma. Studies have shown that high expression of IAP protein can promote the occurrence of various malignant tumors such as lung cancer, head and neck cancer, breast cancer, gastrointestinal cancer, melanoma and multiple myeloma. APG-1387, which is being administered to patients once a week, is a dimer inhibitor that binds both IAP protein monomers and dimers, which effectively overcomes the drawbacks of the existing drugs which cannot act on the dimer of the IAP protein. Ascentage is developing APG-1387 globally, and has completed Phase 1 dose escalation studies with in China and Australia.

About Ascentage Pharma

Ascentage Pharma is a global, clinical-stage biopharmaceutical company, dedicated to the discovery and development of “first-in-class” and “best-in-class” small-molecule targeted therapeutics for addressing unmet medical needs in cancers, Hepatitis B and age-related diseases. Ascentage has world-leading proprietary Protein-Protein Interactions (PPIs)-targeting drug discovery technologies and holds over 80 international patents. Ascentage currently has six small molecule drugs in Phase 1-2 trials in the U.S., Australia and China and additional programs in preclinical stages.

The established R&D pipeline of Ascentage includes the inhibitors to a number of key proteins, including IAP, Bcl-2/Bcl-XL and MDM2-p53, that regulate programmed cell death process; 2nd and/or 3rd generation of kinase inhibitors that overcome mutant resistance in cancer therapy; and inhibitors of epigenetics. For more information, please visit