07 June 2019 | News
Ascentage Pharma presented the data from its most recent clinical trials of APG-115 in China and U.S.
Ascentage Pharma, a globally-focused, clinical-stage biotechnology company engaged in developing novel therapies for cancers, hepatitis B virus and age-related diseases has announced that the company presented new data of two apoptosis-targeted drug candidates APG-115 (a novel MDM2-p53 inhibitor) and APG-1387 (a novel IAP inhibitor) at the 55th Annual Meeting of the American Society of Clinical Oncology (ASCO).
With the theme "Caring for Every Patient, Learning from Every Patient", 2019 ASCO Annual Meeting attracted over 40,000 oncologists and researchers globally to present and share the cutting-edge research and achievements in clinical oncology in Chicago from May 31-June 4.
Ascentage Pharma presented the data from its most recent clinical trials of APG-115 in China and U.S. and the data of phase I study of APG-1387 as a monotherapy or in combination with pembrolizumab in treatments of patients with advanced solid tumors (Board #117).
It is encouraging that in the study of APG-115 as a monotherapy, a confirmed PR was observed in 1 patient with liposarcoma (TP53-WT and MDM2Amp), with target lesion decreased 64%.
"Liposarcoma is a common histological type of malignant soft tissue sarcomas, accounting for about 15% of soft tissue sarcomas. There is no effective treatment for it and the probability of recurrence is high. Liposarcoma belongs to the 'cold tumor' type and has a poor response to immunotherapy," said Pro. Xing Zhang, Chief physician of Melanoma and Sarcoma Medical Oncology Unit of Sun Yat-sen University Cancer Center. She continued, "We believe APG-115 is an efficient MDM2-p53 inhibitor. The data of Phase I study of APG-115 in Chinese patients with liposarcomas is encouraging. We enrolled 14 patients, 8 with liposarcoma; a confirmed PR was observed in one liposarcoma patient after 4 months of treatment discontinuance. Another 5 patients achieved SD (including 2 liposarcoma patients). Based on clinical trial results, APG-115 is well-tolerated and with acceptable safety profile. We expect further data to address the unmet medical needs."
There have also been promising advances in the Phase I study of a novel IAP inhibitor, APG-1387, as a monotherapy in treatments of patients with advanced solid tumors. Drew W. Rasco, M.D., Associate Director of Clinical Research at the START Center for Cancer Care in San Antonio commented: "Among 10 mPC (metastatic pancreatic cancer) patients treated with APG-1387 monotherapy, 3 patients achieved SD. One patient at MTD received SD for >9 cycles (3-wk a cycle) with the best response +6%, still ongoing; one patient achieved SD for > 8 months with best response of -16.7% tumor shrinkage. This preliminary result is worth mentioning, because mPC patients in general have only 3-6 months survival time, and overall survival rate of one year is 8.8%. Currently there is no effective treatment. We look forward to additional data from the on-going studies."
"APG-115 and APG-1387 are two apoptosis targeting products in clinical development of Ascentage Pharma. These results show our further progress in clinical development of targeting apoptosis. We are working hard to provide more therapy options for patients as soon as possible,"said Dr. Dajun Yang, Chairman and CEO of Ascentage Pharma.
- A Phase I Study of a Novel MDM2-P53 Antagonist APG-115 in Chinese Patients with Advanced Solid Tumors
- A Phase I study of a Novel MDM2 Antagonist APG-115 in Patients with Advanced Solid Tumors
- 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
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.
APG-1387 is a novel small molecule IAP inhibitor (Inhibitor of Apoptosis Protein). Ascentage Pharma 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.