SUZHOU, China and ROCKVILLE, Md., Dec. 10, 2019 /PRNewswire/ — Ascentage Pharma (6855.HK), a globally-focused, clinical-stage biotechnology company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and age-related diseases, today announced that the updated results from the Phase I study of the company’s novel investigational drug HQP1351 were reported in an oral presentation at the 61st American Society of Hematology (ASH) Annual Meeting & Exposition. The presentation titled “Updated Safety and Efficacy Results of Phase I Study of HQP1351, a Novel 3rd Generation BCR-ABL Inhibitor in Patients with Tyrosine Kinase Inhibitor-Resistant Chronic Myeloid Leukemia” was delivered by the principal investigator of the study, Qian Jiang, M.D., from Peking University People’s Hospital. In addition, the presentation data was nominated for the “Best of ASH”, a recognition that only a handful of innovative clinical programs from China have achieved.
HQP1351 is a novel, orally active potent 3rd generation BCR-ABL Tyrosine Kinase Inhibitor (TKI) under development for the treatment of patients with chronic myeloid leukemia (CML) resistant to current TKI-therapies including those with T315I mutation.
Key results from the trial:
“Drug-resistance to TKIs is an urgent unmet need and a major challenge in the treatment of CML. No third-generation TKI is currently approved in China, and no imported third-generation TKIs are expected to enter China in the foreseeable future,” said presenting author Dr. Qian Jiang. “The updated results from this Phase I trial of HQP1351 have further validated its tolerability and anti-leukemic potential in refractory chronic myeloid leukemia. We look forward to collecting additional data from the pivotal Phase II trials and hope our work will soon benefit drug-resistant CML patients.”
“The Phase I results on this third-generation BCR-ABL inhibitor have further demonstrated its clinical promise. HQP1351 returned to ASH this year with an oral presentation and a nomination for ‘Best of ASH’, all of which reaffirms the recognition of HQP1351’s potential clinical efficacy and safety by the international hematology community,” said Dr. Yifan Zhai, Chief Medical Officer of Ascentage Pharma. “There are three ongoing pivotal Phase II trials of HQP1351 in China, two of them have reached planned enrollment targets. The data readouts as well as an NDA submission in Chinaare expected in 2020. In addition, the clinical development program of HQP1351 in the U.S. is ready to begin its patient enrollment. We hope HQP1351 will soon get the regulatory approval and reach the market to benefit drug-resistant CML patients in China and around the world.”
HQP1351 is a novel kinase inhibitor developed by Ascentage Pharma. It is an oral third-generation BCR-ABL inhibitor targeting a broad spectrum of BCR-ABL mutants, including those with the T315I mutation, to treat drug-resistant CML patients. A Phase I clinical trial for patients with TKI-resistant CML has been completed and the pivotal Phase II clinical trials are ongoing in China. In addition, a Phase Ib trial in patients with GIST and a Phase Ib trial are also ongoing in China and in the U.S., respectively.
About Ascentage Pharma
Ascentage Pharma (6855.HK) is a globally-focused, clinical-stage biotechnology company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and age-related diseases. The company focuses on developing therapeutics that inhibit protein-protein interactions to restore apoptosis, or programmed cell death. On October 28, 2019, Ascentage Pharma was listed on the Main Board of the Stock Exchange of Hong Kong Limited.
Ascentage Pharma has built a pipeline of eight clinical drug candidates, including a novel, highly potent Bcl-2/Bcl-xL inhibitor, as well as candidates aimed at IAP and MDM2-p53 pathways, and next-generation tyrosine kinase inhibitors. The company has been conducting 28 Phase I/II clinical trials to evaluate the eight drug candidates in the United States, Australia, and China, developing the potential therapies as a single agent or in combination.