AASLD 2022 | Ascentage Pharma to Announce Results from First-in-Human Study of IAP Antagonist APG-1387 in an Oral Report at the AASLD Annual Meeting
Orphan DrugBreakthrough TherapyPriority ReviewFast TrackClinical Result
SUZHOU, China and ROCKVILLE, Md., Oct. 19, 2022 /PRNewswire/ -- Ascentage Pharma (6855.HK), a global biopharmaceutical company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and age-related diseases, today announced that it will release results from the Phase I first-in-human study of APG-1387, the company's investigational inhibitor of apoptosis protein (IAP) antagonist, in patients with chronic hepatitis B (CHB), in an oral presentation at the 73th American Association for the Study of Liver Diseases Annual Meeting (AASLD 2022). Prof. Jinlin Hou, Director of the Center for Liver Diseases and the Institute of Hepatology at the Southern Medical University Affiliated Nanfang Hospital, is the principal investigator of this study.
This presentation will mark the first data readout reporting favorable safety and preliminary efficacy of an IAP antagonist for the treatment of CHB, signifying that the targeted induction of apoptosis and immune modulation in hepatitis B virus-infected cells by IAP antagonists may provide a revolutionary approach for functionally curing hepatitis B.
The AASLD Annual Meeting is one of the most anticipated scientific gatherings in the field of hepatology. This year's congress will take place both online and in-person in Washington, DC, the United States, during November 4th to 8th, 2022.
"We are thrilled to have the opportunity to present on APG-1387, our inhouse designed and developed novel IAP antagonist, to top hepatology experts and researchers from around the world, because being selected by the event signifies the recognition of Ascentage Pharma's R&D capabilities and global innovation strategy,"
said Dr. Yifan Zhai, Chief Medical Officer of Ascentage Pharma. "At the meeting, we will announce detailed results from a Phase I study of APG-1387 in Chinese patients with CHB, and discuss the compound's therapeutic potential for the treatment of this condition. IAP inhibitors could potentially bring a new class of drugs to the treatment of CHB, and this is why are particularly excited to share these results at the meeting."
Title: First-in-Human Study of APG-1387, Targeting Inhibitor of Apoptosis Proteins, For the Treatment of Patients with Chronic Hepatitis B
Abstract #: 32
Session: Parallel 2: Novel Therapeutic Approaches Aimed at Functional Cure of Hepatitis B and D
Date & Time: 9:00-10:30 AM, November 6, 2022, Eastern Time
Venue: Room 146, Walter E. Washington Convention Center
About Ascentage Pharma
Ascentage Pharma (6855.HK) is a globally focused biopharmaceutical company engaged in developing novel therapies for cancers, chronic hepatitis B, and age-related diseases. On October 28, 2019, Ascentage Pharma was listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code 6855.HK.
Ascentage Pharma focuses on developing therapeutics that inhibit protein-protein interactions to restore apoptosis, or programmed cell death. The company has built a pipeline of nine clinical drug candidates, including novel, highly potent Bcl-2, and dual Bcl-2/Bcl-xL inhibitors, as well as candidates aimed at IAP and MDM2-p53 pathways, and next-generation tyrosine kinase inhibitors (TKIs). Ascentage Pharma is also the only company in the world with active clinical programs targeting all three known classes of key apoptosis regulators. The company is conducting more than 50 Phase I/II clinical trials in the US, Australia, Europe, and China. Olverembatinib, the company's core drug candidate developed for the treatment of drug-resistant chronic myeloid leukemia (CML), was granted Priority Review status and a Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) and is already approved for the indication. In addition, olverembatinib was also granted an Orphan Drug Designation (ODD) and a Fast Track Designation (FTD) by the US FDA, and an Orphan Designation by the EU. To date, Ascentage Pharma has obtained a total of 15 ODDs, 2 FTDs, and 2 Rare Pediatric Disease (RPD) designations from the FDA and 1 ODD from the EU for four of the company's investigational drug candidates. Ascentage Pharma has been designated for multiple Major National R&D Projects, including 5 National Major New Drug Discovery and Manufacturing projects, 1 New Drug Incubator status, 4 Innovative Drug Programs, and 1 Major Project for the Prevention and Treatment of Infectious Diseases.
Leveraging its robust R&D capabilities, Ascentage Pharma has built a portfolio of global intellectual property rights and entered into global partnerships with numerous renowned biotechnology and pharmaceutical companies and research institutes such as UNITY Biotechnology, MD Anderson Cancer Center, Mayo Clinic, Dana-Farber Cancer Institute, Merck, AstraZeneca, and Pfizer. The company has built a talented team with global experience in discovering, developing, launching, and commercializing innovative drugs and is setting up world-class commercial manufacturing and Sales & Marketing teams. One pivotal aim of Ascentage Pharma is to continuously strengthen its R&D capabilities and accelerate its clinical development programs, in order to fulfil its mission of addressing unmet clinical needs in China and around the world for the benefit of more patients.
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