Ascentage Pharma Announces First Patient Dosed in China in the Pivotal Phase II Study of Lisaftoclax (APG-2575) in R/R CLL/SLL

SUZHOU, China, and ROCKVILLE, Md., Mar. 14, 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 has dosed the first patient in the pivotal Phase II study of the company’s novel Bcl-2 selective inhibitor, lisaftoclax (APG-2575), for the treatment of relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (R/R CLL/SLL) in China (APG2575CC201 study). Lisaftoclax is the second Bcl-2 inhibitor entering pivotal studies globally.

APG2575CC201 is a single-arm, open-label Phase II pivotal study designed to assess the efficacy and safety of lisaftoclax in patients with R/R CLL/SLL, with the overall response rate (ORR) as the primary endpoint. Based on existing safety and efficacy data of lisaftoclax, the Center for Drug Evaluation (CDE) in China has agreed that the results from the APG2575CC201 study can be used to support the New Drug Application (NDA) for the treatment of R/R CLL/SLL.

CLL/SLL is a hematologic malignancy caused by mature B-cell neoplasms and is among the most common lymphoid neoplasms in the Western world. In North America and Europe, the disease accounts for about 30% of all leukemia cases. In the US, the annual incidence of CLL was 21,250 in the year 2021 with 4320 deaths (SEER report), In China, 15,167 new cases were reported in 2020. With an aging population as well as dietary and lifestyle changes in China, CLL/SLL incidences are expected to rise, with more patients are developing the condition at younger ages, and display aggressive disease progression.

Despite significant initial responses to current first-line treatments such as immunotherapies, chemotherapies, and Bruton’s tyrosine kinase (BTK) inhibitors, relapse and drug-resistance remain a major clinical challenge. Patients with R/R CLL/SLL, commonly experience rapid disease progression and respond poorly to salvage treatments. Therefore, patients with CLL/SLL should be treated in clinical trials whenever possible to explore effective novel therapeutic

Lisaftoclax is a novel, orally administered small-molecule Bcl-2 selective inhibitor being developed by Ascentage Pharma to treat hematologic malignancies and solid tumors by selectively blocking the antiapoptotic protein Bcl-2 and hence restoring the normal apoptosis process in cancer cells. Lisaftoclax is the first China-developed Bcl-2 inhibitor entering clinical development in China, and the second entering pivotal studies globally. Lisaftoclax is being studied in multiple clinical studies in countries and regions including the U.S., China, Australia, and Europe, for a range of solid tumors and hematologic malignancies such as CLL/SLL

“Currently, patients with CLL/SLL have high unmet medical needs globally. Lisaftoclax is a key candidate in our apoptosis-targeted pipeline. In earlier clinical studies, it has demonstrated promising safety and efficacy profile implicating best-in-class potential,” said Dr. Yifan Zhai, Chief Medical Officer of Ascentage Pharma. “Upon dosing the first patient in this pivotal Phase II study, we will actively advance the clinical development of lisaftoclax to hopefully provide a new treatment option to patients with CLL/SLL in China and around the world and allow those patients who now lack effective treatment benefit from this novel therapeutic as early as possible.”

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 40 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 China National Medical Products Administration (NMPA), and is already approved for the indication. In addition, the 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 12 ODDs 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, MSD, AstraZeneca, and Pfizer. 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

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Company Codes: HongKong:6855