Ascentage Pharma Announces Approval for the Phase Ib/II Clinical Study of Bcl-2 Inhibitor APG-2575 for the Treatment of Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma in China

SUZHOU, China, and ROCKVILLE, Md., April 7, 2020 /PRNewswire/ -- Ascentage Pharma (6855.HK), a globally focused, clinical-stage biotechnology company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and age-related diseases, today announced that it has received approval from the Center for Drug Evaluation of the China National Medical Products Administration for the Phase Ib/II study of APG-2575, the company's novel Bcl-2?selective inhibitor, for the treatment of patients with relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (r/r CLL/SLL).

This open-label, Phase Ib/II dose-escalation and dose-expansion study is designed to evaluate the safety, tolerability, and preliminary anticancer activity of APG-2575 as a single agent or in combination therapies for the treatment of patients with r/r CLL/SLL in China.

APG-2575 is a novel, orally administered Bcl-2?selective inhibitor being developed by Ascentage Pharma. APG-2575 is designed to treat several hematologic malignancies by selectively blocking Bcl-2 to restore the normal apoptosis process in cancer cells.

Recent studies have demonstrated that Bcl-2 inhibitors are effective in CLL/SLL, and Bcl-2 inhibitors in combination with Bruton tyrosine kinase inhibitors or CD20 monoclonal antibodies can deepen patient responses and prolong patient survival. These findings provide the rationale for investigating APG-2525 as a single agent or in combination therapies. The Phase I study of APG-2575 monotherapy, previously commenced in the US, Australia, and China, has shown a favorable safety profile and promising anticancer activity, and the preliminary data support the continued clinical investigation of APG-2575.

CLL/SLL is a hematologic malignancy caused by mature B-cell neoplasms, and it mainly affects middle-aged and elderly populations. The condition is characterized by accumulation of cancerous lymphocytes in peripheral blood, bone marrow, spleen, and lymph nodes. CLL/SLL is the most common type of adult leukemia in North America and Europe but is less common in Asian countries such as China and Japan. However, with an aging population, as well as dietary and lifestyle changes in China, CLL/SLL incidences have been increasing, and more patients develop the condition at younger ages and display greater disease progression. Despite significant initial responses to current first-line treatments, many patients with CLL/SLL need continued treatment to maintain these responses, and relapse often portends a poor prognosis. At present, there are even fewer treatment options for patients with CLL/SLL in China than in Europe or North America, hence representing an urgent clinical need for more effective and safe therapies.

"APG-2575 is a key drug candidate in our development pipeline targeting apoptosis, and the first China-made Bcl-2?selective inhibitor to enter clinical studies, with great potential as a monotherapy and in combination therapies in several hematologic malignancies. Upon receiving recent approvals and clearances for several Phase Ib/II studies of APG-2575 in China, Australia, and the US, we are now advancing its clinical development globally," said Dr. Yifan Zhai, Chief Medical Officer of Ascentage Pharma. "There is an enormous unmet clinical need in the treatment of CLL/SLL globally. We will soon initiate this Phase Ib/II study of APG-2575 in China, which hopefully will provide a new treatment option to patients with CLL/SLL."

About Ascentage Pharma

Ascentage Pharma (6855.HK) is a globally focused, clinical-stage biotechnology company engaged in developing novel therapies for cancers, CHB, and age-related diseases. The company focuses on developing therapeutics that inhibit protein-protein interactions to restore apoptosis, or programmed cell death. On October 28, 2019, Ascentage Pharma was listed on the Main Board of the Stock Exchange of Hong Kong Limited.

Ascentage Pharma has built a pipeline of eight clinical drug candidates, including a novel, highly potent Bcl-2/Bcl-xL inhibitor, as well as candidates aimed at IAP and MDM2-p53 pathways, and next-generation tyrosine kinase inhibitors. The company is conducting more than 30 Phase I/II clinical trials to evaluate the eight drug candidates in the US, Australia, and China.

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