Ascentage Pharma Announces First Patient Dosed in Europe in the Phase Ib/II Study of the Bcl-2 inhibitor APG-2575 in Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

SUZHOU,China and ROCKVILLE,Md.,Nov. 25,2020 -- 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 a Phase Ib/II clinical study of the company's novel Bcl-2 inhibitor APG-2575,as a single agent or in combinations for the treatment of patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (r/r CLL/SLL) (APG2575CU101; EudraCT#2020-002736-73),has dosed its first patient in Ukraine. This is the first global clinical study conducted by Ascentage Pharma in Europe.

This global multicenter Phase Ib/II study was designed to evaluate the safety and efficacy of APG-2575 as a single agent or in combinations for the treatment of patients with r/r CLL/SLL. The study has recently obtained Clinical Trial Application (CTA) approvals from the Ministry of Health of Ukraine and the Ministry of Health of the Russian Federation.

CLL is a hematologic malignancy caused by mature B-cell neoplasms and constitutes the most common form of adult leukemia in North America and Europe,accounting for about 30% of all new leukemia cases. The annual incidence rate of CLL is around 2-6 cases per 100,000,and 12.8 cases per 100,000 in the population aged 65 years or older. Despite significant initial responses to current first-line treatments,many patients with CLL need ongoing treatment to maintain these responses,and relapse often portends a poor prognosis. Recent studies in CLL showed that combining a BTK inhibitor with a Bcl-2 inhibitor can deepen responses and shorten treatment durations from long-term to cyclic treatments,making it possible for patients to achieve complete remission and therefore discontinue treatment[1],[2]. These findings have provided a compelling rationale for exploring APG-2575 in combination with BTK inhibitors.

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. APG-2575 is the first China-developed Bcl-2 inhibitor having entered clinical development in China. APG-2575 has received clearances and approvals for multiple Phase Ib/II clinical studies in China,Australia,and the US,and is currently being developed in a range of hematologic malignancies globally. This year,APG-2575 has been granted two Orphan Drug Designations from the US FDA for the treatment of Waldenström macroglobulinemia (WM) and CLL.

"Dosing the first patient in our first clinical study in Europe marks yet another major milestone for Ascentage Pharma. This is the first step for Ascentage to execute expansion of clinical studies to Europe," said Dr. Yifan Zhai,Chief Medical Officer of Ascentage Pharma. "APG-2575 is a key drug candidate in our pipeline targeting apoptosis,and it has demonstrated great therapeutic potential in the treatment of hematologic malignancies. We will expedite the clinical development of APG-2575 and make strides toward offering more treatment options to patients with CLL/SLL globally including in Europe."

References

[1] Cancer Statistics 2020,American Cancer Society

[2] 2020 Cancer Incidence Data,Surveillance,Epidemiology,and End Results Program,US National Cancer Institute

About Ascentage Pharma

Ascentage Pharma (6855.HK) is a globally,CHB,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. 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,and China. HQP1351,the company's core drug candidate developed for the treatment of drug-resistant chronic myeloid leukemia has been granted an Orphan Drug Designation (ODD) and a Fast Track designation by the US Food and Drug Administration (FDA),and a New Drug Application for the drug candidate has been submitted in China. To date,Ascentage Pharma has obtained a total of six ODDs from the FDA for four of the company's investigational drug candidates.

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