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ASCO 2024 | Ascentage Pharma to Present Four Studies, Including an Oral Report Featuring the Latest Data of Olverembatinib in SDH-Deficient GIST

SUZHOU, China and ROCKVILLE, Md., April 25, 2024 /PRNewswire/ — Ascentage Pharma (6855.HK), a global biopharmaceutical company engaged in developing novel therapies for cancer, chronic hepatitis B (CHB), and age-related diseases, announced today that results from four clinical studies of the company’s three key drug candidates have been selected for presentations, including an Oral Report, at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. The three drugs are olverembatinib (HQP1351), the first and only China-approved third-generation BCR-ABL inhibitor; lisaftoclax (APG-2575), a Bcl-2-selective inhibitor; and APG-2449, a FAK/ALK/ROS1 inhibitor.

The ASCO Annual Meeting showcases the most cutting-edge research in clinical oncology and state-of-the-art advanced cancer therapies and is the world’s most influential and prominent scientific gathering of the clinical oncology community. This year’s ASCO Annual Meeting will take place both online and in-person at the McCormick Place, Chicago, IL, the United States, on May 31–June 4, 2024 (local time).

“Entering the seventh consecutive year for our studies to be selected for presentations at the ASCO Annual Meeting, we are honored to have the opportunity to once again showcase our capabilities in global innovation and clinical development at this top international scientific meeting,” said Dr. Yifan Zhai, Chief Medical Officer of Ascentage Pharma. “Our presentations this year include an Oral Report featuring updated data of olverembatinib in patients with succinate dehydrogenase (SDH)-deficient gastrointestinal stromal tumor (GIST), an indication that currently has no effective treatment. Furthermore, we will release detailed data of lisaftoclax in patients with acute myeloid leukemia (AML) and in patients with Waldenstrom macroglobulinemia (WM), as well as those of APG-2449 in patients with non-small cell lung cancer (NSCLC). We look forward to sharing the detailed results from those studies with our colleagues at the meeting. Moving forward, we will remain dedicated to those global clinical development programs of key candidates to hopefully bring more treatment options to patients in need.”

These four clinical studies to be presented at this year’s ASCO Annual Meeting are as follows:

Olverembatinib
Updated efficacy results of olverembatinib (HQP1351) in patients with tyrosine kinase inhibitor (TKI)-resistant succinate dehydrogenase (SDH)-deficient gastrointestinal stromal tumor (GIST) and paraganglioma
Abstract#: 11502
Format: Oral Report
Session Title: Sarcoma
Date and Time: June 3, 2024, Monday, 3:00 PM6:00 PM (Central Time)
First Author: Haibo Qiu, MD, PhD, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China.

APG-2575 (Lisaftoclax)
Safety and efficacy of lisaftoclax, a novel BCL-2 inhibitor, in combination with azacitidine in patients with treatment-naïve or relapsed or refractory acute myeloid leukemia
Abstract#: 6541
Format: Poster Presentation
Session Title: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant
Date and Time: June 3, 2024, Monday, 9:00 AM12:00 PM (Central Time)
First Author: Huafeng Wang, MD, PhD, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China.

Updated efficacy and safety results of BCL-2 inhibitor lisaftoclax (APG-2575) alone or combined with ibrutinib or rituximab in patients (pts) with Waldenström macroglobulinemia (WM)
Abstract#: 7078
Format: Poster Presentation
Session Title: Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia
Date and Time: June 3, 2024, Monday, 9:00 AM– 12:00 PM (Central Time)
First Author: Masa Lasica, MBBS, FRACP, FRCPA, St Vincent’s Hospital, Melbourne, Victoria, Australia.

APG-2449
Updated study results of novel FAK/ALK/ROS1 inhibitor APG-2449 in patients (pts) with non-small-cell lung cancer (NSCLC) resistant to second-generation ALK inhibitors.
Abstract#: 3124
Format: Poster Presentation
Session Title: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology
Date and Time: June 1, 2024, Saturday, 9:00 AM12:00 PM (Central Time)
First Author: Yuxiang Ma, MD, PhD, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China.

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 9 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 40 Phase I/II clinical trials, including 5 global registrational phase III studies, in the US, Australia, Europe, and China. Ascentage Pharma has been designated for multiple Major National R&D Projects, including five Major New Drug Projects, one New Drug Incubator status, four Innovative Drug Programs, and one Major Project for the Prevention and Treatment of Infectious Diseases.

Olverembatinib, the company’s core drug candidate developed for the treatment of drug-resistant chronic myeloid leukemia (CML) and the company’s first approved product, has been granted Priority Review Designations and Breakthrough Therapy Designations by the Center for Drug Evaluation (CDE) of China National Medical Products Administration (NMPA). To date, the drug had been included into the China 2022 National Reimbursement Drug List (NRDL). Furthermore, olverembatinib has been granted an Orphan Drug Designation (ODD) and a Fast Track Designation (FTD) by the US FDA, and an Orphan Designation by the EMA of the EU. To date, Ascentage Pharma has obtained a total of 16 ODDs from the US FDA and 1 Orphan Designation from the EMA of the EU for 4 of the company’s investigational drug candidates.

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, MSD, and AstraZeneca. The company has built a talented team with global experience in the discovery and development of innovative drugs and is setting up its 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.

Forward-Looking Statements

The forward-looking statements made in this article relate only to the events or information as of the date on which the statements are made in this article. Except as required by law, Ascentage Pharma undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events, or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. You should read this article completely and with the understanding that our actual future results or performance may be materially different from what we expect. In this article, statements of, or references to, our intentions or those of any of our Directors or our Company are made as of the date of this article. Any of these intentions may alter in light of future development.

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