Ascentage Pharma Announces First Patient Dosed in the Global Phase Ib/II Clinical Study of Bcl-2 Inhibitor APG-2575 in the United States

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 the global Phase Ib/II clinical study of APG-2575, a Bcl-2 selective inhibitor, as a single agent or in combination for the treatment of relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (r/r CLL/SLL), has dosed its first patient in the United States.

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

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. Ascentage Pharma has previously commenced a Phase I study of APG-2575 as a single agent in the United States, Australia, and China. Ascentage Pharma recently received clearances in China and the United States for three Phase Ib/II clinical studies of APG-2575, continuing clinical development of APG-2575 in multiple disease conditions globally.

"APG-2575 is a key drug candidate in our development pipeline targeting apoptosis. Upon receiving clearance from the US FDA, we promptly initiated the trial and achieved dosing of its first patient," said Dr. Yifan Zhai, Chief Medical Officer of Ascentage Pharma. "We look forward to effectively advancing this critical clinical development program, which hopefully will soon benefit patients with r/r CLL/SLL."

About Ascentage Pharma

Ascentage Pharma (6855.HK) is a globally focused, clinical-stage biotechnology company engaged in developing novel therapies for cancers, chronic hepatitis B (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, S.A.R., China 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 28 Phase I/II clinical trials to evaluate the eight drug candidates in the United States, Australia, and China.

Forward-looking Statement

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, we undertake 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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