SUZHOU, China and ROCKVILLE, Md., June 18, 2024 /PRNewswire/ — Ascentage Pharma (6855.HK), a world biopharmaceutical firm engaged in creating novel therapies for most cancers, continual hepatitis B (CHB), and age-related ailments, introduced at present that it has launched up to date knowledge of the Bcl-2 inhibitor lisaftoclax (APG-2575), one of many firm’s key drug candidates, mixed with novel therapeutic regimens in sufferers with relapsed/refractory (R/R) a number of myeloma (MM) or immunoglobulin light-chain (AL) amyloidosis, in a poster presentation on the 2024 European Hematology Affiliation Hybrid Congress (EHA 2024), happening in Madrid, Spain.

Constructing on outcomes from the research launched for the primary time on the 2023 American Society of Hematology Annual Assembly, the up to date knowledge introduced at EHA 2024 continued to point out spectacular efficacy and favorable security of lisaftoclax-based combos, significantly the mix with pomalidomide and dexamethasone in R/R MM. Furthermore, the research reported an incidence of Grade 3 or increased treatment-related neutropenia of 14.3%, which underscored the regimens’ potential in providing sufferers a secure new therapy choice.

Prof. Sikander Ailawadhi, MD, from Mayo Clinic and the principal investigator of this research, commented, “This is a study of lisaftoclax combined with novel therapeutic regimens in patients with R/R MM or AL amyloidosis. From the primary analysis, it demonstrated that lisaftoclax + pomalidomide in R/R MM could achieve ‰¥very good partial response (VGPR) rate of 33.3%, and higher VGPR along with increasing lisaftoclax dosage. Moreover, lisaftoclax based therapy in both R/R MM and amyloidosis is very well tolerated with Grade 3/4 neutropenia of 14.3%. This convincing data could provide an alternative treatment option to patients with MM and amyloidosis.”

“It is our pleasure to release the updated data of lisaftoclax in patients with R/R MM or AL amyloidosis at this year’s EHA Hybrid Congress,” mentioned Dr. Yifan Zhai, Chief Medical Officer of Ascentage Pharma. “These data underscore the outstanding safety and efficacy profiles of the combination therapies, once again demonstrating these regimens’ global best-in-class potential. We will actively advance this clinical development program to bring patients a safe and effective new treatment option as soon as possible.”

The EHA Hybrid Congress is the biggest gathering of the hematology discipline in Europe. It showcases probably the most cutting-edge research and state-of-the-art modern therapies, attracting over 10,000 scientific consultants and researchers from greater than 100 nations yearly. This 12 months, along with the most recent knowledge of lisaftoclax, Ascentage Pharma additionally launched these of the third-generation BCR-ABL1 inhibitor olverembatinib (HQP1351) and the EED inhibitor APG-5918.

Highlights of the information on lisaftoclax introduced at EHA 2024 are as follows:

Lisaftoclax (APG-2575) Mixed with Novel Therapeutic Regimens in Sufferers (Pts) with Relapsed or Refractory (R/R) A number of Myeloma (MM) or Immunoglobulin Mild-Chain (AL) Amyloidosis

• Summary#: P917
• Presentation Kind: Poster presentation
• Subject: Myeloma and different monoclonal gammopathies “ Medical
• Date & Time: Friday June 14, 2024, 18:00 – 19:00 CEST
• Presenting Writer: Prof. Sikander Ailawadhi, Mayo Clinic Florida

Highlights:

• Background: R/R MM is incurable, with just about inevitable relapse with out applicable therapeutic intervention. AL amyloidosis is a uncommon illness that will trigger severe organ injury or loss of life. Lisaftoclax is a novel, potent, selective BCL-2 inhibitor with scientific advantages in hematologic malignancies and strong tumors and a low reported incidence of opposed occasions (AEs).
• Introduction: The goal of this multicenter research was to guage the protection and efficacy of lisaftoclax mixed with pomalidomide and dexamethasone (Arms A and C) or daratumumab, lenalidomide, and dexamethasone (Arm B) in sufferers with R/R MM (Arms A and B) or R/R AL amyloidosis (Arm C).
• Affected person enrollment and strategies: Sufferers with an Japanese Cooperative Oncology Group (ECOG) efficiency standing ‰¤2 had been administered lisaftoclax every day in repeated 28-day cycles. Pomalidomide, daratumumab, and lenalidomide had been administered per label use. Dexamethasone was administered at 40 mg/day, and sufferers aged>75 had been administered on the lowered dose of 20 mg/day.
  • As of January 25, 2024, 44 sufferers that included 36 sufferers with R/R MM and eight sufferers with R/R AL  amyloidosis had been enrolled within the 3 arms of the research (Arms A, B, and C) to obtain lisaftoclax at varied doses.
  • The median (vary) age of sufferers was 70.5 (24-88) years, 68.2% had been male, and 65.9% had been older than 65 years.
  • The median (vary) variety of strains of prior therapies was 3 (1-19), median (vary) time from prognosis to the primary dose of research drug was 5.5 (1-29) years, and median (vary) variety of therapy cycles was 4 (1-26).
• Efficacy outcomes:
  • In Arm A, 27 sufferers with R/R MM had been efficacy  evaluable. Amongst them, 10 had partial response (PR), 7 had superb PR (VGPR), and a pair of had full response (CR). The general response charge (ORR [PR+VGPR+CR]) was 70.4%.
  • In Arm B, 2 sufferers with R/R MM achieved  CR.
  • In Arm  C, 7 sufferers with R/R AL amyloidosis had been efficacy evaluable, and the ORR was 85.7% (4 VGPRs, 2 CR).
• Security outcomes:
  • Of the 42 sufferers included in security analysis, 10 sufferers skilled Grade ‰¥3 treatment-related opposed occasions (TRAEs), together with neutropenia (14.3%), febrile neutropenia (2.4%). 3 sufferers skilled severe TRAEs that included febrile neutropenia, acute kidney harm, and diarrhea with electrolyte imbalance (1 every).
  • A complete of 24 sufferers discontinued therapy due to illness development (n=15), treatment-emergent  AE (TEAE, n=3), nonadherence (n=1), or investigator/affected person choice (n=5).
• Conclusions: Lisaftoclax plus novel therapeutic regimens was properly tolerated and demonstrated preliminary antitumor exercise in sufferers with both R/R MM or AL amyloidosis.

Lisaftoclax is an investigational drug that has not been permitted in any nation and area.

About Ascentage Pharma

Ascentage Pharma (6855.HK) is a globally centered biopharmaceutical firm engaged in creating novel therapies for cancers, continual hepatitis B, and age-related ailments. On October 28, 2019, Ascentage Pharma was listed on the Foremost Board of the Inventory Trade of Hong Kong Restricted with the inventory code 6855.HK.

Ascentage Pharma focuses on creating therapeutics that inhibit protein-protein interactions to revive apoptosis, or programmed cell loss of life. The corporate has constructed a pipeline of 9 scientific drug candidates, together with novel, extremely potent Bcl-2, and twin Bcl-2/Bcl-xL inhibitors, in addition to candidates geared toward IAP and MDM2-p53 pathways, and next-generation tyrosine kinase inhibitors (TKIs). Ascentage Pharma can be the one firm on the earth with energetic scientific applications focusing on all three identified courses of key apoptosis regulators. The corporate is conducting greater than 40 Section I/II scientific trials, together with 5 world registrational section III research, within the US, Australia, Europe, and China. Ascentage Pharma has been designated for a number of Main Nationwide R&D Initiatives, together with 5 Main New Drug Initiatives, one New Drug Incubator standing, 4 Progressive Drug Applications, and one Main Challenge for the Prevention and Remedy of Infectious Illnesses.

Olverembatinib, the corporate’s core drug candidate developed for the therapy of drug-resistant continual myeloid leukemia (CML) and the corporate’s first permitted product, has been granted Precedence Overview Designations and Breakthrough Remedy Designations by the Heart for Drug Analysis (CDE) of China Nationwide Medical Merchandise Administration (NMPA). Thus far, the drug had been included into the China 2022 Nationwide Reimbursement Drug Record (NRDL). Moreover, olverembatinib has been granted an Orphan Drug Designation (ODD) and a Quick Monitor Designation (FTD) by the US FDA, and an Orphan Designation by the EMA of the EU. Thus far, Ascentage Pharma has obtained a complete of 16 ODDs from the US FDA and 1 Orphan Designation from the EMA of the EU for 4 of the corporate’s investigational drug candidates.

Leveraging its sturdy R&D capabilities, Ascentage Pharma has constructed a portfolio of world mental property rights and entered into world partnerships with quite a few famend biotechnology and pharmaceutical firms and research institutes reminiscent of UNITY Biotechnology, MD Anderson Most cancers Heart, Mayo Clinic, Dana-Farber Most cancers Institute, MSD, and AstraZeneca (NASDAQ:). The corporate has constructed a gifted workforce with world expertise within the discovery and improvement of modern medication and is setting up its world-class business manufacturing and Gross sales & Advertising groups. One pivotal goal of Ascentage Pharma is to repeatedly strengthen its R&D capabilities and speed up its scientific improvement applications, in an effort to fulfil its mission of addressing unmet scientific wants in China and world wide for the good thing about extra sufferers.

Ahead-Wanting Statements

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