ASH 2024: Three Clinical Studies of Ascentage Pharma's Bcl-2 Inhibitor Lisaftoclax to be Presented

ROCKVILLE, Md. and SUZHOU, China, Nov. 6, 2024 -- Ascentage Pharma (6855.HK), a renowned biopharmaceutical company engaged in the discovery, development, and commercialization of therapies addressing global unmet medical needs, particularly for malignancies, recently announced that findings from three clinical studies of their pivotal drug candidate, lisaftoclax (APG-2575), have been chosen for presentation at the 66th American Society of Hematology (ASH) Annual Meeting. This marks the third year in a row that clinical results on lisaftoclax have been selected by the ASH Annual Meeting. The 2024 presentations will also include data from multiple clinical and preclinical studies on four other investigational drugs by Ascentage Pharma: olverembatinib, lisaftoclax, APG-2449, and APG-5918.

Lisaftoclax, an orally administered Bcl-2 inhibitor developed by Ascentage Pharma, has shown promising clinical benefits in treating various hematologic malignancies and solid tumors. At the ASH Annual Meeting this year, Ascentage Pharma will deliver an Oral Report showcasing the latest results from a Phase I/II study involving lisaftoclax in patients with relapsed/refractory multiple myeloma (R/R MM) or immunoglobulin light-chain (AL) amyloidosis. Additionally, the newest data from lisaftoclax combinations in treating chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and myelodysplastic syndrome (MDS) will be presented as posters.

The ASH Annual Meeting is one of the largest global gatherings for the hematology community, featuring the latest scientific advancements in the understanding and treatment of blood diseases. The 66th meeting will be held from December 7-10, 2024, both online and in-person in San Diego, CA.

Dr. Yifan Zhai, Chief Medical Officer of Ascentage Pharma, expressed pride in the repeated selection of lisaftoclax clinical results by the ASH meeting, noting it emphasizes the therapeutic potential of the drug in hematologic malignancies. Dr. Zhai also highlighted the company's extensive capabilities in global innovation and clinical development, as evidenced by multiple studies of their investigational drugs being featured this year. He emphasized Ascentage Pharma's commitment to accelerating their clinical programs to provide more treatment options to patients globally.

The presentations at ASH 2024 will cover various aspects of lisaftoclax research:

1. **Oral Presentation**: Research on lisaftoclax combined with novel therapeutic regimens in patients with R/R MM or AL amyloidosis will be presented. This study evaluates the safety and efficacy of lisaftoclax combined with pomalidomide and dexamethasone (Pd) or daratumumab, lenalidomide, and dexamethasone (DRd) in R/R MM, and with Pd in R/R AL amyloidosis. The study enrolled 52 patients, including 42 with R/R MM and 10 with AL amyloidosis. The results showed significant clinical activity with favorable safety profiles, suggesting lisaftoclax's potential in enhancing treatment outcomes for these conditions.

2. **Poster Presentations**: One of the posters will present findings on lisaftoclax's activity and safety when administered with accelerated ramp-up and then combined with acalabrutinib or rituximab in patients with CLL/SLL, including those previously treated with venetoclax. The study enrolled 176 patients, with the majority being relapsed/refractory. The data indicated high overall response rates, especially in those naive to prior venetoclax therapy, demonstrating lisaftoclax's effectiveness and manageable safety profile.

3. **Poster on MDS**: Another poster will discuss the combination of lisaftoclax with azacitidine in treating MDS. The study involves patients with higher-risk MDS, both treatment-naive and relapsed/refractory. Preliminary results showed promising efficacy and a favorable safety profile, supporting further clinical exploration of this combination therapy.

Ascentage Pharma continues to push the boundaries of research and development in the biopharmaceutical field, aiming to bring innovative therapies to patients worldwide. Their robust pipeline and ongoing clinical trials underscore their commitment to addressing unmet medical needs in oncology and hematology.