SUZHOU, China, and ROCKVILLE, MD., Dec. 14, 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 it has released the updated data from six studies of the company’s three novel drug candidates (olverembatinib, lisaftoclax [APG-2575], and pelcitoclax [APG-1252]) at the 63rd American Society of Hematology (ASH) Annual Meeting.
These results include data from two clinical studies of the company’s novel Bcl-2-selective inhibitor lisaftoclax and one preclinical study of its dual Bcl-2/Bcl-xL inhibitor pelcitoclax that were released in poster presentations at the meeting (clinical data of olverembatinib were also presented in an oral presentation and are available in a separate concurrent press release).
It is worth highlighting that the multicenter, open-label Phase I study of lisaftoclax in patients with hematologic malignancies has demonstrated favorable tolerability of lisaftoclax, without evidence of tumor lysis syndrome (TLS). As of data cutoff on July 27, 2021, 9 of the 25 patients who had received at least one tumor evaluation (of 31 enrolled patients) achieved complete responses (CR) or partial responses (PR). At doses ≥ 200 mg, all 6 patients with chronic lymphocytic lymphoma (CLL) achieved objective responses, including 1 with CR and 5 with PR.
Prof. Jianxiang Wang, MD, Vice President of the Chinese Academy of Medical Sciences’ Hematology Hospital (Institute of Hematology Research), and the principal investigator of the Phase I study of lisaftoclax in hematologic malignancies, commented: “We are very encouraged by those data from the China study of lisaftoclax, especially the responses in all patients with CLL who were treated at 200 mg or higher doses. Compared to drugs of the same class approved outside China, lisaftoclax has demonstrated at least comparable efficacy, improved safety in terms of TLS and hematologic toxicity, and the suitability for more convenient dosing. We look forward to seeing more positive clinical data and hope that lisaftoclax will eventually offer a new treatment option to patients.”
Dr. Yifan Zhai, Chief Medical Officer of Ascentage Pharma, said: “For the first time, we presented data of lisaftoclax and pelcitoclax, two key drug candidates of our apoptosis-targeted pipeline, at the ASH Annual Meeting. These results, following those of olverembatinib, demonstrated Ascentage Pharma’s capabilities in developing novel therapeutics for hematologic malignancies, and the widespread interest in the therapeutic utility and potential clinical advantages of these two drug candidates. These promising data presented at this year’s ASH Annual Meeting, especially the poster showing impressive potential efficacy and safety of lisaftoclax, are very encouraging indeed. As the first China-developed Bcl-2-selective inhibitor entering clinical development in China, lisaftoclax is a drug candidate with clear best-in-class potential. We will continue to accelerate the clinical development of this drug candidate in hematologic indications to allow patients in China and around the world to benefit from it as soon as possible.”
These two abstracts on lisaftoclax presented at the 2021 ASH Annual Meeting are as follows:
A Phase 1 Study to Evaluate the Safety, Pharmacokinetics (PK) and Pharmacodynamics (PD) of Lisaftoclax (APG-2575), a Novel BCL-2 Inhibitor (BCL-2i), in Patients (pts) with Certain Relapsed or Refractory (R/R) Hematologic Malignancies (HMs)
Trial in Progress: Phase 1b Study of Lisaftoclax (APG-2575) As a Single Agent or Combined with Other Therapeutic Agents in Patients with Relapsed and/or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (R/R CLL/SLL)
The abstract on pelcitoclax presented at the 2021 ASH Annual Meeting is as follows:
Antitumor Activity of Dual BCL-2/BCL-Xl Inhibitor Pelcitoclax (APG-1252) in Natural Killer/T-Cell Lymphoma (NK/TCL)
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. Olverembatinib, the company’s core drug candidate developed for the treatment of drug-resistant chronic myeloid leukemia (CML), was granted Priority Review status and a Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) of China National Medical Products Administration (NMPA), and is already approved for the indication. In addition, the olverembatinib was also granted an Orphan Drug Designation (ODD) and a Fast Track Designation (FTD) by the US FDA, and an Orphan Designation by the EU. To date, Ascentage Pharma has obtained a total of 12 ODDs from the US FDA and 1 ODD from the EU for four of the company’s investigational drug candidates. Ascentage Pharma has been designated for multiple Major National R&D Projects, including five National Major New Drug Discovery and Manufacturing projects, one New Drug Incubator status, four Innovative Drug Programs, and one Major Project for the Prevention and Treatment of Infectious Diseases.
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, AstraZeneca, and Pfizer. 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.
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