Ascentage Pharma to Present Three Clinical Trial Updates for APG-115 and APG-1387 at ASCO 2019
On May 23, 2019, Ascentage Pharma, a clinical-stage biopharmaceutical company dedicated to developing innovative drugs in the fields of oncology, hepatitis B, and age-related diseases, announced that it would present updates from three clinical trials of two apoptosis-targeting investigational products via poster presentations at the 55th Annual Meeting of the American Society of Clinical Oncology (ASCO). The two investigational products are the MDM2-p53 inhibitor APG-115 and the IAP inhibitor APG-1387. The annual meeting is scheduled to take place in Chicago from May 31 to June 3, 2019.
The annual ASCO Annual Meeting is the most important and authoritative academic exchange event in the global oncology field, showcasing the latest international advances in clinical oncology research and cancer treatment technologies.
Dr. Zhai Yifan, Chief Medical Officer of Ascentage Pharma, stated: “We are delighted to showcase our multiple clinical advancements, which also demonstrate Ascentage Pharma’s capability to simultaneously advance the clinical development of several pipeline products both domestically and internationally. Through breakthrough scientific research and accelerated clinical development, we look forward to providing patients with more treatment options in the near future.”
Ascentage Pharma will present three latest clinical trial updates at this year’s ASCO Annual Meeting, including:
· Phase I Study of the Novel MDM2-P53 Inhibitor APG-115 for the Treatment of Advanced Soft Tissue Sarcoma in China
Time: June 1 (Saturday), 8:00–11:00 a.m. (Central Time, US)
Poster Number: #116
Preliminary data indicate that APG-115 exhibits robust antitumor activity in MDM2-amplified, TP53-wild-type liposarcoma. Its safety profile and pharmacodynamic effects are consistent with those of other MDM2 inhibitors. Optimization of the current dosing regimen is ongoing.
· Phase I Study of the Novel MDM2 Inhibitor APG-115 for the Treatment of Advanced Solid Tumors
Time: Saturday, June 1, 8:00–11:00 a.m. (Central Time, US)
Poster Number: #118
APG-115 demonstrated good tolerability, with no uncontrollable adverse events observed. A study evaluating APG-115 as an oral monotherapy in patients with advanced solid tumors established the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D) at 100 mg. Further studies investigating APG-115 in combination with pembrolizumab for the treatment of advanced solid tumors are ongoing.
· Phase I Study of the Novel IAP Inhibitor APG-1387 as Monotherapy or in Combination with Pembrolizumab for the Treatment of Advanced Solid Tumors
Time: Saturday, June 1, 8:00–11:00 AM (Central Time, US)
Poster Number: #117
APG-1387 demonstrated favorable tolerability, with no uncontrolled adverse events reported. The potential efficacy of APG-1387, either as monotherapy or in combination with pembrolizumab, for the treatment of advanced solid tumors warrants further investigation, particularly in patients with metastatic pancreatic cancer.
About APG-115
APG-115 is an orally bioavailable, highly selective small-molecule MDM2-p53 inhibitor under development by Ascentage Pharma. APG-115 exhibits high binding affinity for MDM2 and restores p53 tumor suppressor activity by blocking the MDM2-p53 interaction. Currently, APG-115 is undergoing Phase I clinical trials in China and the United States for patients with adenoid cystic carcinoma (ACC) and other sarcomas, as well as a Phase Ib/II clinical trial in the United States evaluating its combination therapy with pembrolizumab.
About APG-1387
APG-1387 is a novel small-molecule inhibitor of inhibitor of apoptosis proteins (IAPs) under development by Ascentage Pharma. The company is developing APG-1387 globally; it has completed Phase I dose-escalation trials in patients with solid tumors in China and Australia, and is currently conducting a Phase I trial in the United States evaluating its combination therapy with pembrolizumab. APG-1387 is also undergoing clinical trials in China for the treatment of hepatitis B.
About Ascentage Pharma
Ascentage Pharma is a China-based, globally oriented clinical-stage biopharmaceutical company dedicated to developing innovative drugs in the therapeutic areas of oncology, hepatitis B, and age-related diseases. The company possesses a proprietary protein-protein interaction (PPI) targeted drug design platform. Ascentage Pharma’s R&D pipeline primarily focuses on inhibitors of key proteins in the apoptosis pathway, such as BCL-2, IAP, and MDM2-p53, to reactivate apoptotic programs in tumor cells, as well as second- and third-generation inhibitors targeting kinase mutations that emerge during cancer treatment. Currently, eight of the company’s novel drug candidates have entered Phase I-II clinical development in China, the United States, and Australia.