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Ascentage Announces CFDA Grants Bcl-2/Bcl-XL inhibitor APG-1252 IND Approval for Treatment of Cancers

Date | 2017.06.26

June 26, 2017 – Ascentage Pharma, a global, clinical-stage biopharmaceutical company, announced today that the China Food and Drug Administration (CFDA) granted Investigational New Drug (IND) approval to APG-1252, a novel Bcl-2/Bcl-XL inhibitor which is discovered and developed by Ascentage, for the treatment of cancers. The CFDA received the IND application to APG-1252 at the end of December 2016, and spent less than six months to complete all the review work.

 

APG-1252 is a novel small molecule drug that helps restore programmed cell death process (apoptosis) through selective inhibition of Bcl-2 family members Bcl-2 and Bcl-XL. APG-1252 obtained IND approval from the FDA in December 2016 and is now in Phase I clinical trial in the United States.

 

“Ascentage has been implementing a global development strategy of advancing our programs in both United States and China, in order to accelerate clinical development and to maximize value of our clinical assets.” Yifan Zhai, MD, Ph.D., Chief Medical Officer of Ascentage, commented, “Dual inhibition of both Bcl-2 and Bcl-XLhas distinctly different therapeutic potential from selective inhibition of Bcl-2. The former potentially addresses solid tumors where Bcl-XLis commonly over-expressed whereas the latter one targets only hematologic malignancies.”

 

“The preclinical data of APG-1252 demonstrates good efficacy in Small Cell Lung Cancer (SCLC) for which there is no effective therapy in clinic. APG-1252 holds promise for SCLC patients and we look forward to advancing APG-1252 into clinical development,” said Professor Yi-Long Wu, Principal Investigator of APG-1252, President of Guangdong Lung Cancer Institute, Director of Sun Yat-sen University Cancer Center and President of Chinese Society of Clinical Oncology (CSCO).

 

Ascentage team is one of the forerunners globally in the field of Bcl-2-targeting drug development. Through years of research, Ascentage team gained in-depth knowledge and expertise in Protein-Protein Interactions (PPIs)-targeting drug design and optimization. Ascentage now has a strong clinical pipeline in the apoptosis space with additional compounds in preclinical development.

 

 

About APG-1252

APG-1252 is an investigational small molecule that selectively binds and inhibits Bcl-2 and Bcl-XL proteins which play pivotal roles in regulating programmed cell death (apoptosis). APG-1252 is designed to overcome the commonly seen on-target toxicity of platelets that is due to Bcl-XL inhibition while maintaining strong anti-tumor potency. APG-1252 is being developed by Ascentage Pharma.

 

 

About Ascentage Pharma

Ascentage Pharma is a global, clinical-stage biopharmaceutical company, dedicated to discovery and development of "first-in-class" and "best-in-class" small-molecule targeted therapeutics for addressing unmet medical needs in cancers, hepatitis B and age-related diseases. Ascentage has world-leading proprietary Protein-Protein Interactions (PPIs)-targeting drug discovery technologies and holds over 100 international patents. Ascentage currently has six small molecule drugs in phase I-II trials in US, Australia and China and additional programs in preclinical stages.

 

The established R&D pipeline of Ascentage includes the inhibitors to a number of key proteins, including IAP, Bcl-2/Bcl-XL and MDM2-p53, that regulate programmed cell death process; 2nd and/or 3rd generation of kinase inhibitors that overcome mutant resistance in cancer therapy; and inhibitors of epigenetics. For more information, please visit www.ascentagepharma.com.