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Ascentage Pharma to Present New Data at 2019 ASCO Annual Meeting from Clinical Trials of MDM2-p53 Antagonist and IAP Inhibitor in Cancers

SUZHOU, China and HONG KONG and ROCKVILLE, Md., May 22, 2019 /PRNewswire/ -- Ascentage Pharma, a globally-focused, clinical-stage biotechnology company engaged in developing novel therapies for cancers, hepatitis B virus and age-related diseases, today announced the presentation of new clinical data for its investigational apoptosis-targeted drug candidates at the 55th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago from May 31-June 4.

"We are excited to present the progress of our three clinical studies," said Yifan Zhai, M.D., Ph.D., Chief Medical Officer of Ascentage Pharma, "These presentations demonstrate Ascentage's capabilities of moving multiple new drug candidates into clinical development across multiple cancer patient populations. Through breakthrough science and agile development, we are striving to deliver novel medicines of differentiated profiles to benefit patients. "

Three abstracts will be presented at 2019 ASCO including:

  • A Phase I Study of a Novel MDM2-P53 Antagonist APG-115 in Chinese Patients with Advanced Soft Tissue Sarcomas

Session Date and Time: Saturday, June 1 at 8:00am - 11:00am CDT
Poster Board: #116

Preliminary data suggested that APG-115 had promising anti-tumor activity in treatment of patients with MDM2-amplification and TP53-WT liposarcoma. Safety profile and PD effect were consistent with other MDM2 inhibitors. Dosing regimen optimization are ongoing.

  • A Phase I Study of a Novel MDM2 Antagonist APG-115 in Patients with Advanced Solid Tumors

Session Date and Time: Saturday, June 1 at 8:00am - 11:00am CDT
Poster Board: #118

APG-115 was well tolerated and had manageable adverse events. The MTD / RP2D of APG-115 monotherapy with oral administration, QOD for 21 days of a 28-day cycle for treatment of patients with advanced solid tumors was determined as 100 mg. Further evaluation of APG-115 in combination with pembrolizumab in patients with advanced solid tumors is ongoing.

  • A Phase I Study of a Novel IAP Inhibitor APG-1387 as a Monotherapy or in Combination with Pembrolizumab in Treatments of Patients with Advanced Solid Tumors

Session Date and Time: Saturday, June 1 at 8:00am - 11:00am CDT
Poster Board: #117

APG-1387 was well tolerated and had manageable adverse events. The potential effects of APG-1387 alone or in combination with pembrolizumab deserve further exploration in patients with advanced solid tumors, especially in the mPC (metastatic pancreatic cancer) patients.

About APG-115

APG-115 is an orally administered, selective, small molecule inhibitor of the MDM2-p53 PPI. APG-115 has strong binding affinity to MDM2 and is designed to activate p53 tumor suppression activity by blocking the MDM2-p53 PPI. APG-115 is currently in Phase I clinical trials in China and the United States in patients with ACC (Adenoid cystic carcinoma ) and other sarcomas. APG-115 is in Phase Ib/II combination study with pembrolizumab in the U.S.

About APG-1387 
APG-1387 is a novel small molecule IAP inhibitor (Inhibitor of Apoptosis Protein). Ascentage is developing APG-1387 globally, and has completed dose escalation Phase I clinical trials in advanced solid tumors in China and Australia, and a Phase I clinical trial of APG-1387 and pembrolizumab combination is currently ongoing in the U.S. APG-1387 is also being investigated for the treatment of patients with chronic hepatitis B virus in China.

About Ascentage Pharma 
Ascentage Pharma is a globally-focused, clinical-stage biotechnology company engaged in developing novel therapies for cancers, hepatitis B virus and age-related diseases. The Company focuses on developing therapeutics that inhibit protein-protein interactions to restore apoptosis, or programmed cell death. Ascentage Pharma has built a pipeline of eight drug candidates in clinical development, including a novel, highly potent Bcl-2/Bcl-xL inhibitor, APG-1252, as well as candidates aimed at IAP and MDM2-p53 pathways, and next-generation tyrosine kinase inhibitors.

Official website: www.ascentagepharma.com

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SOURCE Ascentage Pharma