Ascentage Pharma's Novel Drug HQP1351 for TKI-Resistant Leukemia Selected for Oral Presentation at ASH Annual Meeting

Ascentage Pharma (6855.HK) recently announced that a clinical study of its investigational original Class 1 new drug, HQP1351, has been selected for an oral presentation at the 61st Annual Meeting of the American Society of Hematology (ASH). Professor Huang Xiaojun and Professor Jiang Qian from the Department of Hematology at Peking University People’s Hospital are the principal investigators of this study, with Professor Jiang Qian scheduled to deliver the presentation during the conference. HQP1351 is a novel third-generation tyrosine kinase inhibitor (TKI) indicated for the treatment of patients with chronic myeloid leukemia (CML) who have developed resistance to first- and second-generation TKIs.

Preliminary results from the Phase I study of HQP1351 were selected for an oral presentation at last year’s ASH Annual Meeting, and its updated clinical data have again been selected for an oral presentation at this year’s ASH Annual Meeting. The selection for oral presentations at the ASH Annual Meeting for two consecutive years fully demonstrates the international hematology community’s recognition of the efficacy and safety of HQP1351.

The 61st Annual Meeting of the American Society of Hematology (ASH) will be held in Orlando, USA, from December 7 to 10, 2019. The annual ASH meeting is one of the largest and most comprehensive international academic conferences in the field of hematology worldwide, bringing together the latest and most cutting-edge research and development advances in the field.

The clinical study selected for oral presentation is an update of the Phase I results on the clinical safety and preliminary efficacy of HQP1351, a third-generation BCR-ABL inhibitor designed to overcome TKI resistance. As of May 27, 2019, a total of 101 patients were enrolled in the study. The data demonstrated that HQP1351 was well tolerated and exhibited significant and durable anti-tumor activity in patients with TKI-resistant chronic myeloid leukemia (CML), including those harboring the T315I mutation. HQP1351 is an original Class 1 investigational new drug developed by Ascentage Pharma, which can effectively overcome the resistance limitations associated with first- and second-generation BCR-ABL inhibitors.

In addition to HQP1351, which was selected for an oral presentation, Ascentage Pharma will also present research progress on APG-1252, a dual BCL-2/BCL-xL inhibitor, in the form of a poster at this year’s ASH Annual Meeting. The study focuses on APG-1252’s ability to overcome ibrutinib resistance caused by integrin pathway activation and BCL-xL upregulation. APG-1252 is one of the key investigational candidates in Ascentage Pharma’s apoptosis product pipeline.

HQP1351 is an original Class 1 new drug under development by Ascentage Pharma. It is an oral third-generation BCR-ABL inhibitor that targets various BCR-ABL mutants, including those with the T315I mutation, for the treatment of patients with resistant chronic myeloid leukemia (CML). A Phase I dose-escalation clinical trial in patients with TKI-resistant CML has been completed in China, and a pivotal Phase II clinical trial is currently underway. In addition, a Phase I clinical trial in patients with gastrointestinal stromal tumors (GIST) has been initiated in China.

APG-1252 is a novel, highly potent small-molecule drug independently developed by Ascentage Pharma. It restores apoptosis by selectively inhibiting the Bcl-2 and Bcl-xL proteins, and is indicated for the treatment of solid tumors such as small cell lung cancer (SCLC) and lymphoma. Currently, Phase I dose-escalation trials in patients with advanced cancer are underway in the United States and Australia, while a Phase I single-agent dose-escalation trial in patients with SCLC is being conducted in China.

Ascentage Pharma (6855.HK) 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. On October 28, 2019, Ascentage Pharma was successfully listed on the Main Board of the Hong Kong Stock Exchange.

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; it also includes second- and third-generation inhibitors targeting kinase mutants that emerge during cancer treatment. The company currently has eight Class 1 novel drugs in clinical development, with 28 Phase I/II clinical trials underway in China, the United States, and Australia.