SUZHOU, China and ROCKVILLE, Md., June
21, 2020 /PRNewswire/ -- 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 with CALQUENCE® 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 studies in 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, clinical-stage
biotechnology company engaged in developing novel therapies for
cancers, 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, Australia, 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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or otherwise, after the date on which the statements are made or to
reflect the occurrence of unanticipated events. You should read
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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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SOURCE Ascentage Pharma