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Article source: Medical Rubik's Cube Info
On June 15th, Yasheng Pharmaceutical announced that the company’s clinical trial application for the original innovative drug Bcl-2 inhibitor APG-2575 under development has been approved by the U.
S.
Food and Drug Administration (FDA) for clinical trials, and will start a single drug or a combination with anti-cancer drugs Research on the treatment of advanced ER+ breast cancer or solid tumors
.
The study is a global multi-center, open, phase Ib/II clinical study, which aims to evaluate the progress of APG-2575 monotherapy in patients with advanced solid tumors, or in combination with CDK4/6 inhibitor palbociclib after treatment with CDK4/6 inhibitors.
Or the safety, tolerability, PK characteristics and preliminary efficacy of relapsed ER+/HER2-metastatic breast cancer patients
.
Breast cancer is one of the most common malignant tumors in women.
About 75% of breast cancer patients are hormone receptor positive (HR+) breast cancer[1], mainly estrogen receptor positive (ER+), and about 85% are Bcl-2 overexpression [2]
.
Endocrine therapy is the cornerstone of the treatment of HR+/HER2- breast cancer in the early and metastatic stages
.
APG-2575 is a novel oral Bcl-2 selective small molecule inhibitor under research by Ascent Pharmaceuticals.
It can restore the programmed cell death mechanism (apoptosis) of tumor cells by selectively inhibiting Bcl-2 protein, thereby inducing tumor cell apoptosis , To achieve the purpose of treating tumors
.
APG-2575 is the first locally developed Bcl-2 selective inhibitor that has entered the clinical stage in China.
It has obtained multiple phase Ib/II clinical trials licenses in China, the United States, Australia and Europe, and it is advancing simultaneously globally.
Previously, the results of preclinical studies of APG-2575 combined with palbociclib showed that palbociclib induces cell senescence by inducing cell cycle arrest, while APG-2575 increases the expression of pro-apoptotic proteins such as BIM, down-regulates ER levels, and reduces phosphorylated Rb and cells.
protein levels of cyclin D1 and E
.
Therefore, the combination of Bcl-2 inhibitor and CDK4/6 inhibitor can not only synergistically enhance the induction of cell cycle arrest, but also promote the apoptosis of ER+ breast cancer cells
.
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