Ascentage Pharma and Pfizer Enter Clinical Collaboration to Advance APG-2575 in Combination with CDK4/6 Inhibitor Ibrance® for Metastatic ER+/HER2- Breast Cancer

SUZHOU, China and ROCKVILLE, Md., Nov. 8, 2021 /PRNewswire/ -- a leading biopharmaceutical company dedicated to developing innovative drugs in therapeutic areas such as oncology, hepatitis B, and age-related diseases-- Ascentage Pharma (6855.HK) announced today that the company has entered into a clinical collaboration and drug supply agreement with Pfizer, under which the two parties will jointly develop Ascentage Pharma’s Bcl-2 selective inhibitor lisaftoclax (APG-2575) in combination with Pfizer’s CDK4/6 inhibitor Ibrance.^®(Palbociclib), for the treatment of recurrent, locally advanced or metastatic estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer.

Under the terms of the collaboration, Ascentage Pharma will be responsible for conducting the study, and Pfizer will be responsible for providing the palbociclib required for the study. This global, multicenter, open-label Phase Ib/II dose-escalation and expansion study aims to evaluate the safety, tolerability, and antitumor activity of APG-2575 in combination with palbociclib in patients with metastatic breast cancer.

APG-2575 is a novel investigational oral selective Bcl-2 small-molecule inhibitor developed by Ascentage Pharma. By selectively inhibiting the Bcl-2 protein, it restores the programmed cell death mechanism (apoptosis) in tumor cells, thereby inducing tumor cell apoptosis to achieve the therapeutic goal of cancer treatment. Globally, APG-2575 is, following VENCLEXTA^®(venetoclax), one of the few Bcl-2 selective inhibitors to have entered clinical development. Since June 2021, clinical studies evaluating APG-2575 as monotherapy or in combination therapy for ER-positive breast cancer or solid tumors have been successively approved in the United States and China. The Company has previously been simultaneously advancing the clinical development of APG-2575 for the treatment of various hematologic malignancies in the United States, Europe, China, and Australia.

“This is the first clinical study investigating APG-2575 for the treatment of solid tumors, and we have obtained clinical trial approvals for this study in both the United States and China,” stated Dr. Dajun Yang, Chairman and CEO of Ascentage Pharma. “APG-2575 is a key asset in Ascentage Pharma's apoptosis pipeline, holding significant clinical potential for the treatment of various hematologic malignancies and refractory solid tumors. This collaboration with Pfizer will help accelerate the clinical development of this product. We anticipate that the combination of APG-2575 and palbociclib will demonstrate synergistic effects in the treatment of metastatic breast cancer resistant to the CDK4/6 inhibitor palbociclib, bringing hope to patients worldwide who urgently need new therapeutic options.”

About Ascentage Pharma

Ascentage Pharma is a China-based, globally focused clinical-stage innovative drug R&D company dedicated to developing novel drugs in therapeutic areas such as oncology, hepatitis B, and aging-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 has independently developed a protein-protein interaction (PPI) targeted drug design platform and stands at the forefront of global new drug development in the apoptosis pathway. The company has established a pipeline comprising eight Class 1 innovative small-molecule drugs that have entered clinical development. These include inhibitors targeting key apoptosis pathway proteins such as Bcl-2, IAP, or MDM2-p53, as well as next-generation inhibitors targeting kinase mutations that emerge during cancer therapy. It is the only innovative company globally with clinical-stage candidates across all key protein targets in the apoptosis pathway. Currently, the company is conducting over 40 Phase I/II clinical trials across China, the United States, Australia, and Europe. Ascentage Pharma has undertaken multiple National Science and Technology Major Projects, including five under the "Major New Drug Creation" program (comprising one "Enterprise Innovative Drug Incubation Base" and four "Innovative Drug Research and Development" projects), and one under the "Major Infectious Disease Prevention and Control" program. HQP1351, its core candidate for the treatment of drug-resistant chronic myeloid leukemia (CML), has submitted a New Drug Application (NDA) in China and has been granted priority review and breakthrough therapy designation. This candidate has also received Fast Track designation and Orphan Drug designation from the U.S. FDA. To date, the company has four investigational new drugs that have obtained a total of 12 FDA Orphan Drug designations.

Leveraging its robust R&D capabilities, Ascentage Pharma has established a global intellectual property portfolio and forged worldwide partnerships with leading biotechnology and pharmaceutical companies as well as academic institutions, including UNITY, MD Anderson, Mayo Clinic, Dana-Farber Cancer Institute, Merck, and AstraZeneca. The company has assembled an international team of professionals with extensive experience in the research and clinical development of novel innovative drugs. Concurrently, it is establishing a high-standard commercial manufacturing and marketing team for late-stage products. Ascentage Pharma will continue to enhance its R&D capabilities and accelerate the clinical development of its product pipeline, steadfastly fulfilling its mission to "address unmet clinical needs for patients in China and around the world" to benefit more patients.

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