July 18, 2017 - Yasheng Pharmaceutical, China's leading original drug research and development company, today announced that it has independently developed and developed a new anti-tumor class 1 drug APG-MIP2-p53 with global intellectual property rights. 115 Obtained approval from the State Food and Drug Administration (CFDA) to enter China's clinical practice. This is another significant progress made by APG-115 following the clinical approval of the US FDA in June 2016. It is particularly noteworthy that it is the first MDM2-p53 inhibitor to enter the clinic in China and will fill the domestic target at this target. A gap in the field of drug development.
APG-115 is a small molecule inhibitor that is orally effective and highly selective for targeting MDM2-p53 protein interactions. The p53 gene is the most widely studied tumor suppressor gene. The inactivation of p53 gene plays an important role in tumor formation, and MDM2 is one of the most important inhibitors of p53. When the two are combined, the p53 protein is degraded and the activity is decreased. The anti-cancer effect is weakened. Designing and developing a new mechanism of anti-tumor drugs targeting MDM2-p53 is one of the hotspots and focuses of the global cancer drug research and development field. However, due to the particularity of the MDM2-p53 protein interaction, the development of small molecule inhibitors has brought considerable difficulties, resulting in a handful of research drugs in this field in the world. There are no listed drugs in the world for this target, and there are no other reports in the field of research drugs in this field other than APG-115.
â–²MDM2 regulation of p53 protein
From the perspective of mechanism of action, APG-115 is a second-generation MDM2-p53 inhibitor that can effectively activate p53-regulated apoptosis. "APG-115 is a new mechanism for the new target MDM2-p53, a new structure of small molecule inhibitors, its successful development, will fill the domestic drug gap in the field of MDM2-p53 target. Compared with similar drugs, APG-115 has a better prospect of drug-making and has the best potential of its kind,†said Professor Wang Shaomeng, chief scientific officer of Yasheng Pharmaceutical.
According to Professor Wang Shaomeng, the drugs targeting MDM2 targets are currently in the research and development stage. Roche's idasanutlin (RG-7388), Amgen's AMG-232 and Novartis's HDM201 are among the fastest. Compared with the above drugs, APG-115 has significant activity and drug-administration advantages; and APG-115 can overcome the short-term isomerization reaction of the clinical compound MI-773 and the poor pharmaceutical solubility in the neutral environment, and the activity is More than 10 times that of MI-773.
Preclinical studies have shown that APG-115 can form high-efficiency inhibition on sarcoma, primary liver cancer, primary gastric cancer and other tumors, and the tumor test can completely disappear. In addition, the combination of an MDM2-p53 inhibitor with a Bcl-2 selective inhibitor enhances tumor inhibition. Previous studies [2] have shown that the combination of MDM2-p53 inhibitor and Bcl-2 inhibitor can be produced in both in vitro and in vivo models of Acute Myeloid Leukemia (AML) compared to either drug alone. Strong synergistic anti-tumor effect. Since MDM2-p53 inhibitors are cell cycle-dependent, the induction of apoptosis is only evident when the cells undergo at least two cycles, and Bcl-2 inhibitors can remove this dependence and cause cell death. The power of the program is speeding up. Currently, Roche is conducting a clinical phase I study of its MDM2-p53 inhibitor (idasanutlin/RG-7388) in combination with a Bcl-2 inhibitor (venetoclax/ABT-199) for relapsed or refractory AML.
Dr. Yang Dajun, Chairman and CEO of Yasheng Pharmaceutical, said, “We are very much looking forward to the launch of APG-115 clinical trials in China. The company will accelerate the simultaneous clinical development of APG-115 in China and the United States, and strive to bring the project to market as soon as possible. Patients with clinically malignant tumors such as sarcoma, AML, and Adenoid Cystic Carcinoma (ACC) provide safer and more effective new therapeutic drugs." He pointed out that p53 protein is involved in human tumors. The important role also provides more exploration space for the clinical combination therapy of APG-115. For example, in the United States earlier this year, some patients reported “hyperprogressive†disease during the treatment of PD-1 inhibitors, in which tumors grew abnormally rapidly. An important change in the analysis of tumor genes in these patients is the gene amplification of MDM2 (increased copy number). Therefore, APG-115 is not only to fill the gaps in the country, but more importantly, it can be achieved in clinical joint therapy.
It is noteworthy that Yasheng Pharmaceutical has developed a unique leading core technology in the field of protein-protein interaction targeted drug design and development after several years of continuous research and research. It has been established in the field of apoptosis including MDM2- The rich clinical phase product pipelines such as p53, Bcl-2 and IAP, and the perfect layout make Yasheng Pharmaceutical have more flexible and diverse choices in the design of future clinical combination therapy.
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