Ascentage Pharma Enters Clinical Collaboration to Evaluate the Combination of Bcl-2 and BTK Inhibitors

SUZHOU,China and ROCKVILLE,Md.,June 22,2020 --Ascentage Pharma (6855.HK),a global,clinical-stage biotechnology company engaged in developing novel therapies for cancers,chronic hepatitis B (CHB),and senescence diseases,today announced a clinical collaboration with Acerta Pharma,the hematology research and development center of excellence of AstraZeneca (LSE/STO/NYSE: AZN). Under the terms of the collaboration,Ascentage will sponsor a clinical trial to study the combination of Ascentage Pharma's APG-2575,a selective Bcl-2 inhibitor,and Acerta's CALQUENCE® (acalabrutinib),a Bruton's Tyrosine Kinase (BTK) inhibitor,evaluating the efficacy and safety of this combination therapy in patients with relapsed/refractory (r/r) chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL).

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 withCALQUENCE®in patients with r/r CLL/SLL. The study has already initiated in US with the dosing of first patient,and planned to expand in Europe,and Australia.

CLL/SLL 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. 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 studiesin CLL showed that combining a BTK inhibitor with another Bcl-2 inhibitor can deepen responses and even shorten cyclic treatment,enabling 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.

"We are delighted to enter this collaboration with Acerta. APG-2575 is a key drug candidate in our development pipeline targeting apoptosis,with great potential in the treatment of hematologic malignancies. Collaborating with Acerta helps to accelerate our global clinical development program for APG-2575," said Dr. Dajun Yang,Chairman & CEO of Ascentage Pharma. "Combination therapy is becoming more important in cancer treatment,and the rationale of a Bcl-2 inhibitor combined with a BTK inhibitor is sound. We hope that APG-2575 combined with CALQUENCE® will show synergistic effects in the treatment of CLL/SLL,offering additional treatment options for patients with otherwise limited treatment options around the world."

References

1. Jain N,Keating M,Thompson P,et al. Ibrutinib and venetoclax for first-line treatment of CLL. N Engl J Med 2019;380:2095-2103.

2. Wiestner A. Ibrutinib and venetoclax — doubling down on CLL. N Engl J Med 2019;380:2169-2171.

About APG-2575

APG-2575 is a novel,orally administered Bcl-2‒selective inhibitor being developed by Ascentage Pharma. APG-2575 is designed to treat a variety of hematologic malignancies by selectively blocking Bcl-2 to restore the normal apoptosis process in cancer cells. Since March 2020,the company has received approvals and clearances for several Phase Ib/II studies of APG-2575 in China,Australia,and the US,and is advancing clinical development of APG-2575 for a variety of hematologic malignancy indications.

About Ascentage Pharma

Ascentage Pharma (6855.HK) is a globally,CHB,and senesce 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 30 Phase I/II clinical trials in the US,and China. The company's core drug candidate HQP1351 was recently granted orphan drug and fast-track designations by the US Food and Drug Administration (FDA),and a New Drug Application for HQP1351 has been submitted in China.

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