SUZHOU, China, and ROCKVILLE, MD, Apr. 27, 2022—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 updated results from seven studies involving the company’s five novel drug candidates will be presented at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting. The company will present clinical trials involving the third-generation tyrosine kinase inhibitor (TKI) olverembatinib (HQP1351); as well as the following investigational agents: (1) Bcl-2 inhibitor lisaftoclax (APG-2575); (2) MDM-p53 inhibitor alrizomadlin (APG-115); (3) ALK inhibitor APG-2449; and (4) dual Bcl-2/Bcl-xL inhibitor pelcitoclax (APG-1252).
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 (McCormick Place; Chicago, IL) on June 3–7, 2022.
“This is the fifth consecutive year in which Ascentage-sponsored clinical results have been selected for presentations at the ASCO Annual Meeting,” said Dr. Yifan Zhai, Chief Medical Officer. “We are pleased to be offered a further opportunity to showcase our company’s progress on multiple clinical trials and demonstrate our ample capabilities in global innovation and R&D,” she said.
“In addition to the updated results on lisaftoclax and alrizomadlin, two key drug candidates in our apoptosis-targeted pipeline, we will also release the first-in-human data of APG-2449, a promising drug candidate with potential as the first China-developed third-generation ALK inhibitor,” according to Dr. Zhai.
“We also look forward to disseminating new clinical data on recently approved third-generation TKI olverembatinib in patients with gastrointestinal stromal tumor (GIST),” Dr. Zhai added. “We look forward to sharing these detailed results during the meeting. Moving forward, we will continue to accelerate these and other global clinical development programs, in an effort to expeditiously bring more therapeutic alternatives to patients as soon as possible.”
These seven clinical studies to be presented at this year’s ASCO Annual Meeting are as follows:
Promising antitumor activity of olverembatinib (HQP1351) in patients (pts) with tyrosine kinase inhibitor- (TKI-) resistant succinate dehydrogenase- (SDH-) deficient gastrointestinal stromal tumor (GIST).
A phase Ib/II study of lisaftoclax (APG-2575), a novel BCL-2 inhibitor (BCL-2i), in patients (pts) with relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (R/R CLL/SLL).
Phase Ib/II study of BCL-2 inhibitor lisaftoclax (APG-2575) safety and tolerability when administered alone or combined with a cyclin-dependent kinase 4/6 (CDK4/6) inhibitor in patients with estrogen receptor-positive (ER⁺) breast cancer or advanced solid tumors.
Newly updated activity results of alrizomadlin (APG-115), a novel MDM2/p53 inhibitor, plus pembrolizumab: Phase 2 study in adults and children with various solid tumors.
First-in-human phase I results of APG-2449, a novel FAK and third-generation ALK/ ROS1 tyrosine kinase inhibitor (TKI), in patients (pts) with second-generation TKI-resistant ALK/ROS1 non-small-cell lung cancer (NSCLC) or mesothelioma.
Updated study results of pelcitoclax (APG-1252) in combination with osimertinib in patients (pts) with EGFR-mutant non-small-cell lung cancer (NSCLC).
First-in-human study of pelcitoclax (APG-1252) in combination with paclitaxel in patients (pts) with relapsed/refractory small-cell lung cancer (R/R SCLC).
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 eight 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 US 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 five National Major New Drug Discovery and Manufacturing projects, one New Drug Incubator status, four Innovative Drug Programs, and one 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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