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)
Format: Poster Presentation
Abstract: 3730
Session: 642. Chronic Lymphocytic Leukemia: Clinical and Epidemiological: Poster III
Highlights:
This Chinese, multicenter, open-label, single-agent, Phase I trial is designed to evaluate the safety (including dose-limiting toxicity [DLT] and maximum tolerated dose [MTD]), PK/PD, and preliminary efficacy of lisaftoclax in adults with R/R chronic lymphocytic leukemia (CLL) or non-Hodgkin's lymphoma (NHL).
As of July 27, 2021, 31 patie...
Read More
(All Rights Reserved)