UZHOU, China, and ROCKVILLE, MD., Nov. 5, 2021 — Ascentage Pharma (6855.HK), a global biopharmaceutical company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and age-related diseases, today announced that abstracts on three clinical trials of the company’s novel drug candidate, olverembatinib (HQP1351), have been selected for poster presentations and one oral presentation at the 63rd American Society of Hematology (ASH) Annual Meeting. Presenter, Qian Jiang, MD, and Xiaojun Huang, MD, from the Hematology Department of Peking University People’s Hospital are the principal investigators of the study selected for oral presentation. This is the fourth consecutive year in which studies of olverembatinib were selected for oral presentation by the ASH Annual Meeting, demonstrating strong recognition of the drug candidate’s promising efficacy and safety by the international hematology community.
Olverembatinib is a novel third-generation BCR-ABL tyrosine kinase inhibitor (TKI) developed by Ascentage Pharma for the treatment of patients with chronic myeloid leukemia (CML) resistant to first- and second-generation TKIs, including those with the T315I mutation, which confers resistance against these agents. The New Drug Application (NDA) submitted by Ascentage Pharma for olverembatinib for the treatment of patients with T315I-mutated CML in chronic-phase (CML-CP) or accelerated-phase (CML-AP) is currently under review in China and has already been granted the Priority Review status. Moreover, olverembatinib was granted a Breakthrough Therapy designation by the Center for Drug Evaluation (CDE) of China National Medical Products Administration (NMPA) for the treatment of patients with CML-CP resistant to and/or intolerant of first- and second-generation TKIs.
The ASH Annual Meeting is one of the largest gatherings of the international hematology field, bringing together the latest and most cutting-edge research and other scientific and clinical developments in hematology. The 63rd ASH Annual Meeting will take place on December 11-14, 2021, both virtually and in-person in Atlanta, Georgia, United States. This year, six abstracts on three of Ascentage Pharma’s drug candidates (olverembatinib, lisaftoclax [APG-2575], and pelcitoclax [APG-1252]) have been selected by the ASH Annual Meeting for poster or oral presentations (information on those abstracts about lisaftoclax [APG-2575] and pelcitoclax [APG-1252] are available in a separate press release published in parallel).
“These data to be reported at the 2021 ASH Annual Meeting are very encouraging as they demonstrated olverembatinib’s promising efficacy and tolerability profiles. This is the fourth year in which the clinical progress of this drug candidate has been selected for oral presentation at the ASH Annual Meeting, a strong indication of the international hematology community’s recognition of olverembatinib’s potential as a new treatment option for patients with CML,” said Dr. Yifan Zhai, Chief Medical Officer of Ascentage Pharma. “As China’s first and the world’s second third-generation BCR-ABL inhibitor, olverembatinib offers patients with CML a potential new treatment with clear efficacy and potentially enhanced safety. We hope that olverembatinib will soon be granted market authorization so that patients with CML in China and around the world can start benefiting from this novel therapeutic.”
These abstracts selected for presentations at 2021 ASH Annual Meeting are as follows:
Updated Safety and Efficacy Results of Phase 1 Study of Olverembatinib (HQP1351), a Novel Third-Generation BCR-ABL Tyrosine Kinase Inhibitor (TKI), in Patients with TKI-Resistant Chronic Myeloid Leukemia (CML)
At 36 months, the progression-free survival (PFS) rate was 96.3% (89.1%-98.8%) in patients with CML-CP and 71.4% (40.6%‒88.2%) in those with CML-AP.
Treatment responses were durable and unaffected by baseline BCR-ABL1 mutational status. Corresponding values in patients with> 4 years of treatment were 100% (CHR), 80% (CCyR), and 60% (MMR). The mean PFS rate was 100% at 36 or 48 months and not reached (NR-NR) at 60 months.
Updated Results of Pivotal Phase 2 Trials of Olverembatinib (HQP1351) in Patients (Pts) with Tyrosine Kinase Inhibitor (TKI)-Resistant BCR-ABL1T315I-Mutated Chronic- and Accelerated-Phase Chronic Myeloid Leukemia (CML-CP and CML-AP)
Trial in Progress: Phase 1b Bridging Study of the Pharmacokinetic (PK), Safety, and Efficacy of Orally Administered Olverembatinib (HQP1351) in Patients with Refractory Chronic Myeloid Leukemia (CML) and Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ ALL)
About Ascentage Pharma
Ascentage Pharma (6855.HK) is a globally focused biopharmaceutical company engaged in developing novel therapies for cancers, chronic hepatitis B, and age-related diseases. On October 28, 2019, Ascentage Pharma was listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code 6855.HK.
Ascentage Pharma focuses on developing therapeutics that inhibit protein-protein interactions to restore apoptosis, or programmed cell death. The company has built a pipeline of eight clinical drug candidates, including novel, highly potent Bcl-2, and dual Bcl-2/Bcl-xL inhibitors, as well as candidates aimed at IAP and MDM2-p53 pathways, and next-generation tyrosine kinase inhibitors (TKIs). Ascentage Pharma is also the only company in the world with active clinical programs targeting all three known classes of key apoptosis regulators. The company is conducting more than 40 Phase I/II clinical trials in the US, Australia, Europe, and China. Ascentage Pharma has been designated for multiple Major National R&D Projects, including five Major New Drug Projects, one New Drug Incubator status, four Innovative Drug Programs, and one Major Project for the Prevention and Treatment of Infectious Diseases. Olverembatinib, the company’s core drug candidate developed for the treatment of drug-resistant chronic myeloid leukemia (CML), has been granted an Orphan Drug Designation (ODD) and a Fast Track Designation (FTD) by the US FDA. A New Drug Application (NDA) for HQP1351 has been submitted and subsequently granted Priority Review status and a Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) in China. To date, Ascentage Pharma has obtained a total of 12 ODDs from the US FDA for four of the company’s investigational drug candidates.
Leveraging its robust R&D capabilities, Ascentage Pharma has built a portfolio of global intellectual property rights and entered into global partnerships with numerous renowned biotechnology and pharmaceutical companies and research institutes such as UNITY Biotechnology, MD Anderson Cancer Center, Mayo Clinic, Dana-Farber Cancer Institute, MSD, and AstraZeneca. The company has built a talented team with global experience in the discovery and development of innovative drugs and is setting up its world-class commercial manufacturing and Sales & Marketing teams. One pivotal aim of Ascentage Pharma is to continuously strengthen its R&D capabilities and accelerate its clinical development programs, in order to fulfil its mission of addressing unmet clinical needs in China and around the world for the benefit of more patients.
The forward-looking statements made in this article relate only to the events or information as of the date on which the statements are made in this article. Except as required by law, Ascentage Pharma undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events, or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. You should read this article completely and with the understanding that our actual future results or performance may be materially different from what we expect. In this article, statements of, or references to, our intentions or those of any of our Directors or our Company are made as of the date of this article. Any of these intentions may alter in light of future development.