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 six studies of the company's three drug candidates (olverembatinib [HQP1351], lisaftoclax [APG-2575], and pelcitoclax [APG-1252]) have been selected for poster presentations and one oral presentation at the 63rd American Society of Hematology (ASH) Annual Meeting. These data include two clinical studies of the company's novel Bcl-2-selective inhibitor lisaftoclax and one preclinical study of the dual Bcl-2/Bcl-xL inhibitor pelcitoclax.
Among those studies, 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 response (CR) or partial response (PR). At doses ≥ 200 mg, all 6 patients with chronic lymphocytic lymphoma (CLL) achieved objective responses, including 1 with CR and 5 with PR.
"For the first time, we are presenting data of lisaftoclax and pelcitoclax, two key drug candidates of our apoptosis-targeted pipeline, at the ASH Annual Meeting, amid widespread interest in the therapeutic utility and potential clinical advantages of these two drug candidates," said Dr. Yifan Zhai, Chief Medical Officer of Ascentage Pharma. "We are very encouraged by those promising data to be reported at this year's ASH Annual Meeting, especially the poster showing impressive potential efficacy and safety of lisaftoclax. Lisaftoclax is the first China-developed Bcl-2-selective inhibitor entering clinical development in China. We will 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."
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 development 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 (information on these abstracts of olverembatinib are available in a separate press release published in parallel).
These two abstracts on lisaftoclax that have been selected for presentations 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)
Format: Poster Presentation
Abstract: 3730
Session: 642. Chronic Lymphocytic Leukemia: Clinical and Epidemiological: Poster III
Time: Monday, December 13, 2021; 6:00 PM – 8:00 PM EDT
Highlights:
This Chinese, multicenter, open-label, single-agent, Phase I trial is evaluating the safety (including dose-limiting toxicity [DLT] and maximum tolerated dose [MTD]), efficacy, PK, and PD of lisaftoclax in adults with R/R chronic lymphocytic leukemia (CLL) or non-Hodgkin's lymphoma (NHL).
As of July 27, 2021, 31 patients had been enrolled and treated with lisaftoclax at doses ranging from 20 to 800 mg. Patients had a median (range) of 4 (1-14) prior lines of treatment and diagnoses of CLL/SLL (n=9), mantle cell lymphoma (MCL; n=6), marginal zone lymphoma (MZL...
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