APG-1387治疗hbv一期情况

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https://ichgcp.net/clinical-trials-registry/NCT03585322

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完成日期
2019-10-30

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Ascentage Pharma Announces Acceptance of IND Application by China FDA for Clinical Study of Novel IAP Inhibitor to Treat Hepatitis B Infection
January 8, 2018
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, CHINA | 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.

hchu

APG-1387是Ascentage制药公司发现并正在开发的一种新型Smac模拟小分子IAP抑制剂(凋亡蛋白抑制剂)。研究表明，IAP蛋白的高表达可促进肺癌、头颈癌、乳腺癌、胃肠道癌、黑色素瘤和多发性骨髓瘤等多种恶性肿瘤的发生。Ascentage正在全球开发APG-1387，并在中国和澳大利亚完成了癌症1期剂量递增研究，美国目前正在进行APG-1387联合免疫肿瘤治疗的1期试验。在临床前研究中，APG-1387显著降低了HBV DNA和HBV表面抗原。

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在临床前研究中，APG-1387显著降低了HBV DNA和HBV表面抗原。