Ascentage Pharma Announces Acceptance of IND Application by China FDA for Clinical Study of Novel IAP Inhibitor to Treat Hepatitis B Infection

APG-1387's apoptosis mechanism shown to be potentially curative in preclinical studies
First apoptosis-targeted IAP inhibitor against HBV being pursued in China

ROCKVILLE, Md. and HONG KONG, Jan. 8, 2018 /PRNewswire-USNewswire/ -- Ascentage Pharma, a global clinical-stage biopharmaceutical company dedicated to developing apoptosis-targeted therapies for cancers and other diseases, today announced that the China Food and Drug Administration (CFDA) has accepted the Investigational New Drug (IND) application for APG-1387, a novel small molecule IAP inhibitor for the treatment of the Hepatitis B virus (HBV) infection. APG-1387 is the first IAP inhibitor to be studied in patients with HBV in China--which accounts for approximately one-third of HBV carriers globally--and is among the first to be developed globally.

"The antiviral treatments currently in development and on the market for chronic HBV are effective at suppressing production of the virus, but lack the ability to effectively eliminate the infection, necessitating chronic use of antiviral therapies," said Jinlin Hou M.D., Principal Investigator of APG-1387, Vice Chairman of Chinese Foundation for Hepatitis Prevention and Control, Chairman of Asia-Pacific Association for the Study of Liver (APASL) 2017, former President of Society of Infectious Diseases of Chinese Medical Association (CMA), Director of Nanfang Hospital Liver Cancer of Southern Medical University. "With a unique apoptosis mechanism that includes binding to both IAP protein monomers and dimers, APG-1387 has the potential to clear HBV infection in patients."

APG-1387 is a novel and highly specific antagonist for inhibitors of Apoptosis Inhibitors (IAPs), which is independently developed by Ascentage Pharma in China. It degrades IAPs by mimicking the endogenous Smac molecule to induce programmed cell death or apoptosis. In the preclinical studies finished by Prof. Xiaoyong Zhang (Nanfang Hospital, Southern Medical University), upregulated IAPs expression in liver tissue of chronic hepatitis B patient may promote HBV-infected hepatocytes survival during immune clearance of HBV, resulted in persistent infection. APG-1387 treatment effectively targeted IAPs in both liver cells and lymphocytes, then promoted HBV-specific T cells - mediated clearance of DNA and antigens to cure HBV infection. The potential advantage of IAP inhibitors in the treatment of HBV infection, is their ability to preferentially eliminate infected cells without affecting healthy cells, which is largely dependent on the virus specific T cells recognition.

Commented Yifan Zhai, M.D. Ph.D., Chief Medical Officer of Ascentage: "The acceptance of our IND application in China is an important next step in our global development strategy to address the critical need for more meaningful and breakthrough HBV therapies."

Ascentage is also currently investigating APG-1387 in cancer clinical trials. It has previously completed Phase 1 dose escalation studies with APG-1387 in China and Australia in cancer and recently received IND acceptance for the drug candidate in the U.S. for the treatment of advanced solid tumors and hematologic malignancies in combination with an immuno-oncology therapy.

About APG-1387
APG-1387 is a novel Smac mimetic, small molecule IAP inhibitor (Inhibitor of Apoptosis Protein), 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. Ascentage is developing APG-1387 globally, and has completed Phase 1 dose escalation studies in cancer in China and Australia, and a Phase 1 trial of APG-1387 in combination with an immuno-oncology therapy is currently ongoing in the U.S. APG-1387 is also being investigated for the treatment of the Hepatitis B infection. In preclinical studies, APG-1387 significantly reduced both HBV DNA and HBV surface antigen.

About Hepatitis B
Hepatitis B virus (HBV) is an infection that attacks the liver and can cause both acute and chronic disease. The virus is transmitted through contact with the blood or other body fluids of an infected person. Patients with acute illness may experience symptoms that last several weeks, including yellowing of the skin and eyes (jaundice), dark urine, extreme fatigue, nausea, vomiting and abdominal pain, and in extreme cases, patients develop acute liver failure, which can lead to death. In some people, the Hepatitis B virus can also cause a chronic liver infection that can later develop into cirrhosis (a scarring of the liver) or liver cancer.

About Ascentage Pharma
Ascentage Pharma is a globally-focused, clinical-stage biopharmaceutical company developing novel small molecule therapies for cancers, hepatitis B and age-related diseases. Based on breakthrough technology from the University of Michigan, the Company's expertise is in designing therapeutics that inhibit protein-protein interactions to restore apoptosis, or programmed cell death, in cancers. Ascentage has built a rich pipeline of six clinical candidates, including a novel, highly potent Bcl-2/Bcl-xL inhibitor, APG-1252, as well as candidates aimed at IAP and MDM2-p53 pathways, and next-generation tyrosine kinase inhibitors. For more information, please visit www.ascentagepharma.com.

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